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1.  P009: Fighting Fatigue: Designing a Multidisciplinary Intervention for Cancer-Related Fatigue 
Current Oncology  2012;19(5):e373.
This program was developed in response to the pervasiveness of fatigue reported by cancer patients. Patients of the Northeast Cancer Centre (necc), including those receiving care at one of 14 Community Oncology Clinic Network (cocn) sites, are routinely screened for distress using the Edmonton Symptom Assessment System (esas). Patients reporting cancerrelated fatigue (crf) were referred to the Supportive Care Program (scp) for individual interventions, including psychosocial, nutrition, and physiotherapy services. To ensure access for patients to receive guidance encompassing a variety of strategies for crf, a psychoeducational class was developed by an inter-professional team within the scp at necc.
The scp created an inter-professional committee to develop an interactive, psychoeducational class for cancer patients. The focus was multidimensional, supported with current evidence-based guidelines on fatigue, and developed with expertise from the fields of social work, neuropsychology, nutrition, and physiotherapy. Additional input was received from a group of cancer survivors. A electronic slide presentation and patient workbook highlight objectives, including understanding crf, learning management strategies, and building a personalized plan. The class is professionally facilitated by members of the scp and offered monthly at the necc. Patients are welcome to bring caregivers. Several strategies to promote the intervention included centre-wide distribution of posters and information sessions for oncology health care providers.
An integrated psychoeducational intervention targeting crf was created and offered to patients of the necc beginning in spring 2012. Initial feedback via formal evaluation was overwhelmingly positive as it related to patients receiving evidence-based guidelines to self-manage crf.
To improve accessibility for patients throughout Northeastern Ontario, this intervention will be offered by telemedicine in fall 2012. In future research, patient-reported outcomes for the management of crf will be tracked.
PMCID: PMC3457896
2.  Patient education integrated with acupuncture for relief of cancer-related fatigue randomized controlled feasibility study 
Cancer-related fatigue (CRF) is a prominent clinical problem. There are calls for multi-modal interventions.
We assessed the feasibility of delivering patient education integrated with acupuncture for relief of CRF in a pilot randomized controlled trial (RCT) with breast cancer survivors using usual care as control. Social cognitive and integrative medicine theories guided integration of patient education with acupuncture into a coherent treatment protocol. The intervention consisted of two parts. First, patients were taught to improve self-care by optimizing exercise routines, improving nutrition, implementing some additional evidence-based cognitive behavioral techniques such as stress management in four weekly 50-minute sessions. Second, patients received eight weekly 50-minute acupuncture sessions. The pre-specified primary outcome, CRF, was assessed with the Brief Fatigue Inventory (BFI). Secondary outcomes included three dimensions of cognitive impairment assessed with the FACT-COGv2.
Due to difficulties in recruitment, we tried several methods that led to the development of a tailored recruitment strategy: we enlisted oncologists into the core research team and recruited patients completing treatment from oncology waiting rooms. Compared to usual care control, the intervention was associated with a 2.38-point decline in fatigue as measured by the BFI (90% Confidence Interval from 0.586 to 5.014; p <0.10). Outcomes associated with cognitive dysfunction were not statistically significant.
Patient education integrated with acupuncture had a very promising effect that warrants conducting a larger RCT to confirm findings. An effective recruitment strategy will be essential for the successful execution of a larger-scale trial.
Trial registration
PMCID: PMC3144009  PMID: 21703001
3.  ASCPRO Recommendations for the Assessment of Fatigue as an Outcome in Clinical Trials 
Development of pharmacologic and behavioral interventions for cancer-related fatigue (CRF) requires adequate measures of this symptom. A guidance document from the Food and Drug Administration offers criteria for the formulation and evaluation of patient-reported outcome measures used in clinical trials to support drug or device labeling claims.
An independent working group, ASCPRO (Assessing Symptoms of Cancer Using Patient-Reported Outcomes), has begun developing recommendations for the measurement of symptoms in oncology clinical trials. The recommendations of the Fatigue Task Force for measurement of CRF are presented here.
There was consensus that CRF could be measured effectively in clinical trials as the sensation of fatigue or tiredness, impact of fatigue/tiredness on usual functioning or as both sensation and impact. The ASCPRO Fatigue Task Force constructed a definition and conceptual model to guide measurement of CRF. ASCPRO recommendations do not endorse a specific fatigue measure but clarify how to evaluate and implement fatigue assessments in clinical studies. The selection of a CRF measure should be tailored to the goals of the research. Measurement issues related to various research environments were also discussed.
There exist in the literature good measures of CRF for clinical trials with strong evidence of clarity and comprehensibility to patients, content and construct validity, reliability, sensitivity to change in conditions in which one would expect them to change (assay sensitivity), and sufficient evidence to establish guides for interpreting changes in scores. Direction for future research is discussed.
PMCID: PMC2909842  PMID: 20538190
Cancer-related fatigue; self-report measures; clinical trials; patient-reported outcomes
4.  Wide Awake Parenting: study protocol for a randomised controlled trial of a parenting program for the management of post-partum fatigue 
BMC Public Health  2013;13:26.
Exhaustion and fatigue are commonly experienced by parents during the post-partum period, and can have implications for daily functioning, mental health and parenting practices. There is a need for the development of effective interventions to assist parents with the management of fatigue. This paper outlines the procedure for a randomised controlled study which aims to test the efficacy of Wide Awake Parenting, a program for the management of fatigue in the postnatal period.
Parents with an infant less than 6 months of age, and from seven Local Government Areas in Melbourne, Australia were invited to participate in this study. Parents were randomised to receive the Wide Awake Parenting program (intervention groups) or usual care (control group) offered by health services. The Wide Awake Parenting program provides parents with psycho-education and information about fatigue, and strategies to reduce its effects either via a self-directed method, or professionally led with a home visit and telephone support. Baseline data will be collected prior to randomisation, and further data will be collected at 2- and 6-weeks post intervention.
To our knowledge this is the first randomised controlled trial of a program which compares the efficacy of a self-management approach and health professional assistance for the management of fatigue in the early post-partum period. If effective, it could offer an important, universal public health management approach to this common health concern.
Trial registration number
Australian New Zealand Clinical Trials Registry, ACTRN12611000133932.
PMCID: PMC3553020  PMID: 23311498
Fatigue; Parents; Post-partum; Pycho-educational Intervention
5.  Assessment of Cancer-Related Fatigue: Role of the Oncology Nurse in Translating NCCN Assessment Guidelines into Practice 
Despite the availability of the National Comprehensive Cancer Network’s (NCCN) evidence-based practice guidelines for the assessment and management of Cancer-Related Fatigue (CRF), assessment of CRF still is not routinely performed at many institutions and oncology practice settings. Numerous patient-, provider-, and system-related barriers exist that hinder the translation of these guidelines into practice by oncology nurses and other health care providers. Oncology nurses can play vital roles in decreasing these barriers to promote the translation of these guidelines into practice to insure that CRF is routinely assessed, managed, and documented. This article briefly reviews the NCCN CRF guidelines for CRF assessment and discusses many of the common barriers that exist that hinder the translation of the CRF guidelines into practice settings. Current assessment/screening and measurement scales validated in patients with cancer are highlighted, and case studies reflect the vital roles that oncology nurses can play in the assessment, documentation, and ongoing monitoring of a patient with CRF.
PMCID: PMC3776587  PMID: 18842523
6.  RESTORE: an exploratory trial of an online intervention to enhance self-efficacy to manage problems associated with cancer-related fatigue following primary cancer treatment: study protocol for a randomized controlled trial 
Trials  2013;14:184.
There are over 25 million people worldwide living with or beyond cancer and this number is increasing. Cancer survivors face a range of problems following primary treatment. One of the most frequently reported and distressing symptoms experienced by cancer survivors is fatigue. There is growing support for survivors who are experiencing problems after cancer treatment to engage in supported self-management. To date there is some evidence of effective interventions to manage fatigue in this population; however, to our knowledge there are no online resources that draw on this information to support self-management of fatigue. This paper describes the protocol for an exploratory randomized controlled trial of an online intervention to support self-management of cancer-related fatigue after primary cancer treatment.
This is a parallel-group two-armed (1:1) exploratory randomized controlled trial including 125 cancer survivors experiencing fatigue (scoring ≥4 on a unidimensional 11-point numeric rating scale for fatigue intensity) within five years of primary treatment completion with curative intent. Participants will be recruited from 13 NHS Trusts across the UK and randomized to either the online intervention (RESTORE), or a leaflet comparator (Macmillan Cancer Backup, Coping with Fatigue). The primary outcome is a change in Perceived Self-Efficacy for Fatigue Self-Management (as measured by the Perceived Self-Efficacy for Fatigue Self-Management Instrument). Secondary outcomes include impact on perception and experience of fatigue (measured by the Brief Fatigue Inventory), and quality of life (measured by the Functional Assessment of Cancer Therapy - General and the Personal Wellbeing Index). Outcome measures will be collected at baseline, 6 weeks (completion of intervention), and 3 months. Process evaluation (including telephone interviews with recruiting staff and participants) will determine acceptability of the intervention and trial processes.
Data from this trial will be used to refine the intervention and contribute to the design of an effectiveness trial. This intervention will be expanded to address other cancer-related problems important to cancer survivors following primary cancer treatment.
Trial registration
PMCID: PMC3698162  PMID: 23786716
Cancer survivors; Fatigue; Online; Self-efficacy; Self-management
7.  Testing a Theoretical Model of Perceived Self-Efficacy for Cancer-Related Fatigue Self-Management and Optimal Physical Functional Status 
Nursing research  2009;58(1):32-41.
Critical gaps exist in the understanding of cancer symptoms, particularly for cancer-related fatigue (CRF). Existing theories and models do not examine the key role perceived self-efficacy (PSE) plays in a person's ability to manage symptoms.
To test the hypothesis that physical functional status (PFS) is predicted through patient characteristics, CRF, other symptoms, and PSE for fatigue self-management in persons with cancer.
This study is a secondary data analysis from the baseline observation of two randomized control trials. The combined data set includes 298 subjects who were undergoing a course of chemotherapy. Key variables included physiological and contextual patient characteristics, the severity from CRF and other symptoms, PSE, and PFS. Path analysis examined the relationships among the variables in the proposed theoretical model.
Persons with cancer reported CRF as the most prevalent symptom among a mean of 7.4 other concurrent symptoms. The severity from CRF had a direct and indirect effect on PFS, with CRF having a direct adverse impact on PFS (t = -7.02) and an indirect adverse effect as part of the severity from the other symptoms (t = 9.69) which also adversely impacted PFS (t = -2.71). Consistent with the proposed theoretical model, PSE had a positive effect on the PFS (t = 2.87) of persons with cancer while serving as a mediator between CRF severity and PFS.
Cancer-related fatigure is prevalent and related to the presence of other symptoms, and PSE for fatigue self-management is an important factor influencing CRF and PFS. A foundation is provided for future intervention studies to increase PSE to achieve optimal PFS in persons with cancer.
PMCID: PMC3108333  PMID: 19092553
8.  A Randomized Controlled Trial of Home-Based Exercise for Cancer-Related Fatigue in Women during and after Chemotherapy with or without Radiation Therapy 
Cancer nursing  2010;33(4):245-257.
Few studies have evaluated an individualized home-based exercise prescription during and after cancer treatment.
The purpose was to evaluate the effectiveness of a home-based exercise training intervention, the PRO-SELF FATIGUE CONTROL PROGRAM on the management of cancer related fatigue.
Participants (N=119) were randomized into one of three groups: Group 1 (EE) received the exercise prescription throughout the study; Group 2 (CE) received their exercise prescription after completing cancer treatment; Group 3 (CC) received usual care. Patients completed the Piper Fatigue Scale, General Sleep Disturbance Scale, Center for Epidemiological Studies-Depression scale, and Worst Pain Intensity Scale.
All groups reported mild fatigue levels, sleep disturbance and mild pain, but not depression. Using multilevel regression analysis significant linear and quadratic trends were found for change in fatigue and pain (i.e., scores increased, then decreased over time). No group differences were found in the changing scores over time. A significant quadratic effect for the trajectory of sleep disturbance was found, but no group differences were detected over time. No significant time or group effects were found for depression.
Our home-based exercise intervention had no effect on fatigue or related symptoms associated with cancer treatment. The optimal timing of exercise remains to be determined.
Implications for practice
Clinicians need to be aware that some physical activity is better than none, and there is no harm in exercise as tolerated during cancer treatment. Further analysis is needed to examine the adherence to exercise. More frequent assessments of fatigue, sleep disturbance, depression, and pain may capture the effect of exercise.
PMCID: PMC2891044  PMID: 20467301
9.  Impact of an Evidence-Based Medicine Curriculum Based on Adult Learning Theory 
To develop and implement an evidence-based medicine (EBM) curriculum and determine its effectiveness in improving residents' EBM behaviors and skills.
Description of the curriculum and a multifaceted evaluation, including a pretest-posttest controlled trial.
University-based primary care internal medicine residency program.
Second- and third-year internal medicine residents (N =34).
A 7-week EBM curriculum in which residents work through the steps of evidence-based decisions for their own patients. Based on adult learning theory, the educational strategy included a resident-directed tutorial format, use of real clinical encounters, and specific EBM facilitating techniques for faculty.
Behaviors and self-assessed competencies in EBM were measured with questionnaires. Evidence-based medicine skills were assessed with a 17-point test, which required free text responses to questions based on a clinical vignette and a test article. After the intervention, residents participating in the curriculum (case subjects) increased their use of original studies to answer clinical questions, their examination of methods and results sections of articles, and their self-assessed EBM competence in three of five domains of EBM, while the control subjects did not. The case subjects significantly improved their scores on the EBM skills test (8.5 to 11.0, p =.001), while the control subjects did not (8.5 to 7.1, p =.09). The difference in the posttest scores of the two groups was 3.9 points (p =.001, 95% confidence interval 1.9, 5.9).
An EBM curriculum based on adult learning theory improves residents' EBM skills and certain EBM behaviors. The description and multifaceted evaluation can guide medical educators involved in EBM training.
PMCID: PMC1497200  PMID: 9436893
evidence-based medicine (EBM); curriculum; residents; medical education; adult learning theory
10.  Communication Skills Training for Oncology Professionals 
Journal of Clinical Oncology  2012;30(11):1242-1247.
To provide a state-of-the-art review of communication skills training (CST) that will guide the establishment of a universal curriculum for fellows of all cancer specialties undertaking training as oncology professionals today.
Extensive literature review including meta-analyses of trials, conceptual models, techniques, and potential curricula provides evidence for the development of an appropriate curriculum and CST approach. Examples from the Memorial Sloan-Kettering Cancer Center CST program are incorporated.
A core curriculum embraces CST modules in breaking bad news and discussing unanticipated adverse events, discussing prognosis, reaching a shared treatment decision, responding to difficult emotions, coping with survivorship, running a family meeting, and transitioning to palliative care and end of life. Achievable outcomes are growth in clinician's self-efficacy, uptake of new communication strategies and skills, and transfer of these strategies and skills into the clinic. Outcomes impacting patient satisfaction, improved adaptation, and enhanced quality of life are still lacking.
Future communication challenges include genetic risk communication, concepts like watchful waiting, cumulative radiation risk, late effects of treatment, discussing Internet information and unproven therapies, phase I trial enrollment, and working as a multidisciplinary team. Patient benefits, such as increased treatment adherence and enhanced adaptation, need to be demonstrated from CST.
PMCID: PMC3341141  PMID: 22412145
11.  Effects and feasibility of a multi-disciplinary orientation program for newly registered cancer patients: design of a randomised controlled trial 
Diagnosis and treatment of cancer can contribute to psychological distress and anxiety amongst patients. Evidence indicates that information giving can be beneficial in reducing patient anxiety, so oncology specific information may have a major impact on this patient group. This study investigates the effects of an orientation program on levels of anxiety and self-efficacy amongst newly registered cancer patients who are about to undergo chemotherapy and/or radiation therapy in the cancer care centre of a large tertiary Australian hospital.
The concept of interventions for orienting new cancer patients needs revisiting due to the dynamic health care system. Historically, most orientation programs at this cancer centre were conducted by one nurse. A randomised controlled trial has been designed to test the effectiveness of an orientation program with bundled interventions; a face-to-face program which includes introduction to the hospital facilities, introduction to the multi-disciplinary team and an overview of treatment side effects and self care strategies. The aim is to orientate patients to the cancer centre and to meet the health care team. We hypothesize that patients who receive this orientation will experience lower levels of anxiety and distress, and a higher level of self-efficacy.
An orientation program is a common health care service provided by cancer care centres for new cancer patients. Such programs aim to give information to patients at the beginning of their encounter at a cancer care centre. It is clear in the literature that interventions that aim to improve self-efficacy in patients may demonstrate potential improvement in health outcomes. Yet, evidence on the effects of orientation programs for cancer patients on self-efficacy remains scarce, particularly with respect to the use of multidisciplinary team members. This paper presents the design of a randomised controlled trial that will evaluate the effects and feasibility of a multidisciplinary orientation program for new cancer patients.
Trial registration
Current Controlled Trials ACTRN12609000018213
PMCID: PMC2781003  PMID: 19906312
12.  Randomized controlled trial of a teleconference fatigue management plus physical activity intervention in adults with multiple sclerosis: rationale and research protocol 
BMC Neurology  2012;12:122.
Chronic fatigue and inactivity are prevalent problems among individuals with multiple sclerosis (MS) and may independently or interactively have detrimental effects on quality of life and ability to participate in life roles. However, no studies to date have systematically evaluated the benefits of an intervention for both managing fatigue and promoting physical activity in individuals with MS. This study involves a randomized controlled trial to examine the effectiveness of a telehealth intervention that supports individuals with MS in managing fatigue and increasing physical activity levels.
A randomly-allocated, three-parallel group, time-series design with a social support program serving as the control group will be used to accomplish the purpose of the study. Our goal is to recruit 189 ambulatory individuals with MS who will be randomized into one of three telehealth interventions: (1) a contact-control social support intervention, (2) a physical activity-only intervention, and (3) a physical activity plus fatigue management intervention. All interventions will last 12 weeks and will be delivered entirely over the phone. Our hypothesis is that, in comparison to the contact-control condition, both the physical activity-only intervention and the physical activity plus fatigue management intervention will yield significant increases in physical activity levels as well as improve fatigue and health and function, with the physical activity plus fatigue management intervention yielding significantly larger improvements. To test this hypothesis, outcome measures will be administered at Weeks 1, 12, and 24. Primary outcomes will be the Fatigue Impact Scale, the Godin Leisure-Time Exercise Questionnaire (GLTEQ), and Actigraph accelerometers. Secondary outcomes will include the SF-12 Survey, Mental Health Inventory, Multiple Sclerosis Impact Scale, the Community Participation Indicator, and psychosocial constructs (e.g., self-efficacy).
The proposed study is novel, in that it represents a multi-disciplinary effort to merge two promising lines of research on MS: fatigue management and physical activity promotion. Collectively, the proposed study will be the largest randomized controlled trial to examine the effects of a lifestyle physical activity intervention in people with MS.
Trial registration
PMCID: PMC3495833  PMID: 23072517
13.  Reducing Patient Barriers to Pain and Fatigue Management 
Pain and fatigue are recognized as critical symptoms that impact quality of life (QOL) for cancer patients. The barriers to pain and fatigue relief have been classified into three categories: patient, professional and system barriers. The overall objective of this trial is to test the effects of the “Passport to Comfort” intervention on reducing barriers to pain and fatigue management for ambulatory care cancer patients. This intervention demonstrates innovation by translating the evidence-based guidelines for pain and fatigue as developed by the National Comprehensive Cancer Network (NCCN) into practice. This quasi-experimental, comparative study utilizes a Phase 1 control group of usual care followed sequentially by a Phase 2 intervention group in which educational and systems change efforts were directed toward improved pain and fatigue management. This paper reports on the patient barriers and the patient education intervention to overcome these barriers. A sample of 187 cancer patients with breast, lung, colon, or prostate cancers, and pain and/or fatigue of ≥ 4 (moderate to severe), were recruited. Patients in the intervention group received four educational sessions on pain/fatigue assessment and management, whereas patients in the control group received usual care. Pain and fatigue barriers and patient knowledge were measured at baseline, one month, and three months post-accrual. Patients in the intervention group experienced significant improvements in pain and fatigue measures immediately post-intervention, and these improvements were sustained over time. The “Passport to Comfort” intervention was effective in reducing patient barriers to pain and fatigue management, as well as increasing patient knowledge regarding pain and fatigue.
PMCID: PMC2844345  PMID: 20303026
Barriers; pain; fatigue
14.  Design of the Physical exercise during Adjuvant Chemotherapy Effectiveness Study (PACES):A randomized controlled trial to evaluate effectiveness and cost-effectiveness of physical exercise in improving physical fitness and reducing fatigue 
BMC Cancer  2010;10:673.
Cancer chemotherapy is frequently associated with a decline in general physical condition, exercise tolerance, and muscle strength and with an increase in fatigue. While accumulating evidence suggests that physical activity and exercise interventions during chemotherapy treatment may contribute to maintaining cardiorespiratory fitness and strength, the results of studies conducted to date have not been consistent. Additional research is needed to determine the optimal intensity of exercise training programs in general and in particular the relative effectiveness of supervised, outpatient (hospital- or physical therapy practice-based) versus home-based programs.
This multicenter, prospective, randomized trial will evaluate the effectiveness of a low to moderate intensity, home-based, self-management physical activity program, and a high intensity, structured, supervised exercise program, in maintaining or enhancing physical fitness (cardiorespiratory fitness and muscle strength), in minimizing fatigue and in enhancing the health-related quality of life (HRQoL). Patients receiving adjuvant chemotherapy for breast or colon cancer (n = 360) are being recruited from twelve hospitals in the Netherlands, and randomly allocated to one of the two treatment groups or to a 'usual care' control group. Performance-based and self-reported outcomes are assessed at baseline, at the end of chemotherapy and at six month follow-up.
This large, multicenter, randomized clinical trial will provide additional empirical evidence regarding the effectiveness of physical exercise during adjuvant chemotherapy in enhancing physical fitness, minimizing fatigue, and maintaining or enhancing patients' quality of life. If demonstrated to be effective, exercise intervention programs will be a welcome addition to the standard program of care offered to patients with cancer receiving chemotherapy.
Trial registration
This study is registered at the Netherlands Trial Register (NTR 2159)
PMCID: PMC3002358  PMID: 21138561
15.  A Randomized Controlled Trial of Qigong Exercise on Fatigue Symptoms, Functioning, and Telomerase Activity in Persons with Chronic Fatigue or Chronic Fatigue Syndrome 
Annals of Behavioral Medicine  2012;44(2):160-170.
Chronic fatigue is common in the general population. Complementary therapies are often used by patients with chronic fatigue or chronic fatigue syndrome to manage their symptoms.
This study aimed to assess the effect of a 4-month qigong intervention program among patients with chronic fatigue or chronic fatigue syndrome.
Sixty-four participants were randomly assigned to either an intervention group or a wait list control group. Outcome measures included fatigue symptoms, physical functioning, mental functioning, and telomerase activity.
Fatigue symptoms and mental functioning were significantly improved in the qigong group compared to controls. Telomerase activity increased in the qigong group from 0.102 to 0.178 arbitrary units (p < 0.05). The change was statistically significant when compared to the control group (p < 0.05).
Qigong exercise may be used as an alternative and complementary therapy or rehabilitative program for chronic fatigue and chronic fatigue syndrome.
PMCID: PMC3442161  PMID: 22736201
Qigong; Exercise; Chronic fatigue; Telomerase; Randomized controlled trial
16.  A 4-Week Home-Based Aerobic and Resistance Exercise Program During Radiation Therapy: A Pilot Randomized Clinical Trial 
During radiation therapy, cancer patients may report cancer-related fatigue (CRF), which impairs aerobic capacity, strength, muscle mass, and, ultimately, quality of life (QOL). The purpose of this pilot clinical trial was to examine the feasibility and initial efficacy of a home-based aerobic and progressive resistance exercise intervention for aerobic capacity, strength, muscle mass, CRF, and QOL. Daily steps walked (DSW), daily minutes of resistance exercise (MRE), and number of resistance exercise days (RED) were assessed to evaluate intervention adherence. Breast and prostate cancer patients (n = 38) beginning radiation therapy were randomized to undergo 4 weeks of exercise or no exercise. Participants in the exercise group demonstrated good adherence to the exercise intervention, with significantly more DSW, MRE, and RED at post intervention and 3 month follow-up than controls. Participants in the exercise intervention exhibited significantly higher QOL and significantly lower CRF post intervention and at 3-month follow-up than controls. Results of this pilot study provide positive preliminary evidence that exercise during radiation may be beneficial for cancer patients.
PMCID: PMC3034389  PMID: 19831159
17.  Evaluation of an internet-based aftercare program to improve vocational reintegration after inpatient medical rehabilitation: study protocol for a cluster-randomized controlled trial 
Trials  2013;14:26.
Mental disorders are the main reasons for rising proportions of premature pension in most high-income countries. Although inpatient medical rehabilitation has increasingly targeted work-related stress, there is still a lack of studies on the transfer of work-specific interventions into work contexts. Therefore, we plan to evaluate an online aftercare program aiming to improve vocational reintegration after medical rehabilitation.
Vocationally strained patients (n = 800) aged between 18 and 59 years with private internet access are recruited in psychosomatic, orthopedic and cardiovascular rehabilitation clinics in Germany. During inpatient rehabilitation, participants in stress management group training are cluster-randomized to the intervention or control group. The intervention group (n = 400) is offered an internet-based aftercare with weekly writing tasks and therapeutic feedback, a patient forum, a self-test and relaxation exercises. The control group (n = 400) obtains regular e-mail reminders with links to publicly accessible information about stress management and coping. Assessments are conducted at the beginning of inpatient rehabilitation, the end of inpatient rehabilitation, the end of aftercare, and 9 months later. The primary outcome is a risk score for premature pension, measured by a screening questionnaire at follow-up. Secondary outcome measures include level of vocational stress, physical and mental health, and work capacity at follow-up.
We expect the intervention group to stabilize the improvements achieved during inpatient rehabilitation concerning stress management and coping, resulting in an improved vocational reintegration. The study protocol demonstrates the features of internet-based aftercare in rehabilitation.
Trial registration
International Standard Randomised Controlled Trial Number Register (ISRCTN:ISRCTN33957202)
PMCID: PMC3598370  PMID: 23351836
Internet-based intervention; Medical rehabilitation; Premature pension; Rehabilitation aftercare; Stress management; Work disability; Work stress
18.  Time Course and Predictors for Cancer-Related Fatigue in a Series of Oropharyngeal Cancer Patients Treated with Chemoradiation Therapy 
The Oncologist  2012;17(4):569-576.
Cancer-related fatigue (CRF) is an underestimated phenomenon and is prevalent in head and neck cancer patients. Results on aspects of the time course of CRF and its correlation with pain as well as the impact of pain on CRF are discussed.
Learning Objectives
After completing this course, the reader will be able to: Discuss the incidence of cancer-related fatigue and the impact it has on cancer patients.Evaluate clinical correlates of cancer-related fatigue and describe possible interventions.Explain the time course of cancer-related fatigue before, during, and post-treatment and the effect treatment has on patients for years after treatment.
This article is available for continuing medical education credit at
Cancer-related fatigue (CRF) is a highly prevalent and underestimated symptom in cancer patients. This study aims to analyze CRF solely in a cohort of oropharyngeal cancer patients who underwent treatment with radiotherapy (RT).
In January 2008 to June 2010, 87 consecutive oropharyngeal carcinoma patients underwent definitive RT. Concurrent chemotherapy was used for 94% of patients. The median prescription dose to the planning target volume of the gross or clinical tumor volume was 70 Gy for definitive cases (n = 84) and 66 Gy for postoperative cases (n = 3), both delivered over 6.5 weeks. A normalized 12-point numeric rating scale assessed CRF from patient visits before, during, and after RT.
The median follow-up of living patients was 14 months. Fatigue peaked 1–2 weeks post-RT and remained higher than baseline for up to 2 years post-RT in 50% of patients. The average fatigue score at the time of completion of therapy or maximum thereafter up to 1 year post-RT was significantly worse than baseline. Patients who experienced pain had a trend toward significance with association for a higher maximum difference in fatigue from baseline. Karnofsky performance status score, weight change, and mood disorders did not correlate with CRF.
Fatigue was a common treatment-related symptom in this uniform cohort of patients with oropharyngeal cancer. RT was highly correlated with worsening of CRF. Pain control has the potential to help mitigate CRF in patients experiencing pain, and will need to be confirmed using larger datasets.
PMCID: PMC3336831  PMID: 22398160
Oropharynx; Fatigue; Pain; Radiotherapy; Cancer; Chemotherapy; Head and neck; Pain
19.  Effect of Methylphenidate in Patients with Cancer-Related Fatigue: A Systematic Review and Meta-Analysis 
PLoS ONE  2014;9(1):e84391.
Cancer-related fatigue (CRF) is a common symptom affecting patients with cancer. There are an increasing number of trials examining potential treatments for CRF. Methylphenidate represents one of the most researched drugs and an up-to-date assessment of the evidence for its use is needed. Trials of methylphenidate for CRF provided inconsistent results. This meta-analysis was aimed at assessing the effect and safety of methylphenidate on CRF.
We comprehensively searched the Pubmed, EMBASE, PSYCHInfo and the Cochrane databases in order to identify published studies on the effect of methylphenidate on CRF. Primary outcomes included fatigue. Secondary outcomes included depression, cognition and adverse effects.
A meta-analysis was conducted on five randomized controlled trials and 498 patients were enrolled. Despite a large placebo effect observed in the studies included, pooled data suggested therapeutic effect of methylphenidate on CRF. Subgroup Analyses showed that the efficacy of methylphenidate on CRF is getting better with prolonging treatment duration, with a MD of −3.70 (95% CI −7.03– −0.37, p = 0.03) for long-time group and a MD of −2.49 (95% CI −6.01–1.03, p = 0.17) for short-time group. In general, there was no impact of methylphenidate on depression and cognition associated with CRF. Adverse events were similar between methylphenidate and placebo groups except that more patients reported vertigo, anxiety, anorexia and nausea in methylphenidate group compared to placebo group.
Existing trials of methylphenidate on CRF provided limited evidence for the use of methylphenidate to treat CRF. The absolute numbers still remain small, and further confirmation is needed before firm recommendations on their usage and safety can be made in the treatment of CRF.
PMCID: PMC3885551  PMID: 24416225
20.  Web-based self-management with and without coaching for type 2 diabetes patients in primary care: design of a randomized controlled trial 
Self-management is recognized as the cornerstone of overall diabetes management. Web-based self-management programs have the potential of supporting type 2 diabetes patients with managing their diabetes and reducing the workload for the care provider, where the addition of online coaching could improve patient motivation and reduce program attrition. This study aims to test the hypothesis that a web-based self-management program with coaching will prove more effective on improving patient self-management behavior and clinical outcome measures than a web-based self-management program without coaching.
The effects of a web-based self-management program with and without coaching will be tested with a nested randomized controlled trial within a healthcare group in the Netherlands. In one year 220 type 2 diabetes patients will be randomized into an intervention group (n = 110) or a control group (n = 110). The control group will receive only the online self-management program. The intervention group will receive the online self-management program and additional online coaching. Participants will be followed for one year, with follow-up measurements at 6 and 12 months.
The intervention being tested is set to support type 2 diabetes patients with their diabetes self-management and is expected to have beneficial effects on self-care activities, well being and clinical outcomes. When proven effective this self-management support program could be offered to other health care groups and their type 2 diabetes patients in the Netherlands.
Trial registration
Nederlands Trial Register NTR4064
PMCID: PMC3840688  PMID: 24238104
Type 2 diabetes mellitus; Self-management; Web-based; Asynchronized coaching
21.  Mindfulness based stress reduction study design of a longitudinal randomized controlled complementary intervention in women with breast cancer 
The stress of a breast cancer diagnosis and its treatment can produce a variety of psychosocial sequelae including impaired immune responses. Mindfulness Based Stress Reduction (MBSR) is a structured complementary program that incorporates meditation, yoga and mind-body exercises. Despite promising empirical evidence for the efficacy of MBSR, there is a need for randomized controlled trials (RCT). There is also a need for RCTs investigating the efficacy of psychosocial interventions on mood disorder and immune response in women with breast cancer. Therefore, the overall aim is to determine the efficacy of a Mindfulness Based Stress Reduction (MBSR) intervention on well-being and immune response in women with breast cancer.
Methods and design
In this RCT, patients diagnosed with breast cancer, will consecutively be recruited to participate. Participants will be randomized into one of three groups: MBSR Intervention I (weekly group sessions + self-instructing program), MBSR Intervention II (self-instructing program), and Controls (non-MBSR). Data will be collected before start of intervention, and 3, 6, and 12 months and thereafter yearly up to 5 years. This study may contribute to evidence-based knowledge concerning the efficacy of MBSR to support patient empowerment to regain health in breast cancer disease.
The present study may contribute to evidence-based knowledge concerning the efficacy of mindfulness training to support patient empowerment to regain health in a breast cancer disease. If MBSR is effective for symptom relief and quality of life, the method will have significant clinical relevance that may generate standard of care for patients with breast cancer.
Trial registration NCT01591915
PMCID: PMC3850932  PMID: 24088535
Breast cancer; Mindfulness based stress reduction; Randomized controlled trials; Well-being
22.  Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE): a randomized controlled trial protocol 
BMC Neurology  2013;13:5.
Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting.
The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP), compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC). Two secondary objectives are to compare ASAP to a true (active monitoring only) usual and customary (UCC) therapy group and to compare DEUCC and UCC.
Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT) time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS) hand domain is a secondary outcome measure.
The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary hypothesis is that the improvement in log-transformed WMFT time will be greater for the ASAP than the DEUCC group. This pre-planned hypothesis will be tested at a significance level of 0.05.
ICARE will test whether ASAP is superior to the same number of hours of usual therapy. Pre-specified secondary analyses will test whether 30 hours of usual therapy is superior to current usual and customary therapy not controlled for dose.
Trial registration Identifier: NCT00871715
PMCID: PMC3547701  PMID: 23311856
Stroke; Brain infarction; Hemiparesis; Neurorehabilitation; Task-specific training; Motor recovery; Occupational therapy; Physical therapy
23.  Methylphenidate and/or a Nursing Telephone Intervention for Fatigue in Patients With Advanced Cancer: A Randomized, Placebo-Controlled, Phase II Trial 
Journal of Clinical Oncology  2013;31(19):2421-2427.
Cancer-related-fatigue (CRF) is common in advanced cancer. The primary objective of the study was to compare the effects of methylphenidate (MP) with those of placebo (PL) on CRF as measured using the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) fatigue subscale. The effect of a combined intervention including MP plus a nursing telephone intervention (NTI) was also assessed.
Patients and Methods
Patients with advanced cancer with a fatigue score of ≥ 4 out of 10 on the Edmonton Symptom Assessment Scale (ESAS) were randomly assigned to one of the following four groups: MP+NTI, PL+NTI, MP + control telephone intervention (CTI), and PL+CTI. Methylphenidate dose was 5 mg every 2 hours as needed up to 20 mg per day. The primary end point was the median difference in FACIT-F fatigue at day 15. Secondary outcomes included anxiety, depression, and sleep.
One hundred forty-one patients were evaluable. Median FACIT-F fatigue scores improved from baseline to day 15 in all groups: MP+NTI (median score, 4.5; P = .005), PL+NTI (median score, 8.0; P < .001), MP+CTI (median score, 7.0; P = .004), and PL+CTI (median score, 5.0; P = .03). However, there were no significant differences in the median improvement in FACIT-F fatigue between the MP and PL groups (5.5 v 6.0, respectively; P = .69) and among all four groups (P = .16). Fatigue (P < .001), nausea (P = .01), depression (P = .02), anxiety (P = .01), drowsiness (P < .001), appetite (P = .009), sleep (P < .001), and feeling of well-being (P < .001), as measured by the ESAS, significantly improved in patients who received NTI. Grade ≥ 3 adverse events did not differ between MP and PL (40 of 93 patients v 29 of 97 patients, respectively; P = .06).
MP and NTI alone or combined were not superior to placebo in improving CRF.
PMCID: PMC3691358  PMID: 23690414
24.  A Qualitative Analysis of Cancer-Related Fatigue in Ambulatory Oncology 
Clinical journal of oncology nursing  2012;16(1):10.1188/12.CJON.E26-E32.
The purpose of this study was to describe patients’ perceptions of the causes, relief, related symptoms, meaning, and suffering secondary to cancer-related fatigue (CRF). Two hundred and fifty two (n=252) patients with breast, lung, colon, and prostate cancers were enrolled in a quasi-experimental study to test the effects of a clinical intervention on reducing barriers to symptom management in ambulatory care. Analysis of data reported in this paper was derived from the Piper Fatigue Scale-Revised (PFS-R). Using qualitative research methods and content analysis, written statements related to the impact of CRF were coded using the following themes: patients’ perceptions of cancer related fatigue, the causes, relief, related symptoms, meaning, and suffering. Comments were categorized and reviewed for content.
Overall, CRF had a significant impact on the physical, psychological, social, and spiritual wellbeing. CRF limited the ability of participants to function, socialize, and participate in enjoyable activities. Emotional issues as a result of CRF were common. The negative impact of CRF on patient’s overall well-being alters the meaning and suffering related to the cancer experience. The assessment of personal meaning and suffering related to CRF is an important component of the multidimensional assessment of CRF. This will enable nurses to better understand the suffering related to CRF.
PMCID: PMC3822779  PMID: 22297018
25.  Feasibility of a Patient-Controlled Cognitive Behavioral Intervention for Pain, Fatigue, and Sleep Disturbance in Cancer 
Oncology nursing forum  2010;37(3):E151-E159.
To evaluate the feasibility of a patient-controlled cognitive-behavioral intervention for pain, fatigue, and sleep disturbance during treatment for advanced cancer, and to assess initial efficacy of the intervention in controlling symptoms.
One-group pretest-posttest design.
Outpatient oncology clinics at a Comprehensive Cancer Center in the Midwestern United States.
30 adults with advanced (recurrent or metastatic) colorectal, lung, prostate, or GYN cancer receiving chemotherapy or radiotherapy.
Participants completed baseline measures (demographics, symptom inventory) and received education and training to use an MP3 player loaded with 12 cognitive-behavioral strategies (e.g., relaxation exercises, guided imagery, nature sound recordings). Participants used the strategies as needed for symptom management over the following 2-weeks, keeping a log of symptom ratings with each use. Following the two-week intervention, participants completed a second symptom inventory and an evaluation of the intervention.
Main Research Variables
Feasibility, patient-controlled cognitive-behavioral intervention, pain, fatigue, sleep disturbance.
73% of the 43 eligible patients agreed to participate (N=30) and of these, 90% (n=27) completed the study. The majority of participants reported that they enjoyed the intervention, had learned useful skills, and perceived improvement in their symptoms. Symptom scores at 2-weeks did not differ significantly from baseline, however significant reductions in pain, fatigue, and sleep disturbance severity were found in ratings made immediately before and after use of a cognitive-behavioral strategy.
The patient-controlled cognitive-behavioral intervention appears feasible for further study and could reduce day-to-day severity of co-occurring pain, fatigue, and sleep disturbance.
Implications for Nursing
A randomized controlled trial is necessary to test efficacy of the intervention for co-occurring pain, fatigue, and sleep disturbance. In the mean time, based on previous efficacy studies, cognitive-behavioral strategies can be recommended for certain individual symptoms.
PMCID: PMC2864954  PMID: 20439200

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