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1.  The EORTC emotional functioning computerized adaptive test: phases I–III of a cross-cultural item bank development 
Psycho-oncology  2013;23(4):397-403.
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group is currently developing computerized adaptive testing measures for the Quality of Life Questionnaire Core-30 (QLQ-C30) scales. The work presented here describes the development of an EORTC item bank for emotional functioning (EF), which is one of the core domains of the QLQ-C30.
According to the EORTC guidelines on module development, the development of the EF item bank comprised four phases, of which the phases I–III are reported in the present paper. Phase I involved defining the theoretical framework for the EF item bank and a literature search. Phase II included pre-defined item selection steps and a multi-stage expert review process. In phase III, feedback from cancer patients from different countries was obtained.
On the basis of literature search in phase I, a list of 1750 items was generated. These were reviewed and further developed in phase II with a focus on relevance, redundancy, clarity, and difficulty. The development and selection steps led to a preliminary list of 41 items. In phase III, patient interviews (N = 41; Austria, Denmark, Italy, and the UK) were conducted with the preliminary item list, resulting in some minor changes to item wording. The final list comprised 38 items.
The phases I–III of the developmental process have resulted in an EF item list that was well accepted by patients in several countries. The items will be subjected to larger-scale field testing in order to establish their psychometric characteristics and their fit to an item response theory model.
PMCID: PMC3974657  PMID: 24217943
2.  Project Onward: An Innovative E-health Intervention for Cancer Survivors 
Psycho-oncology  2012;22(4):947-951.
This study examined the feasibility and acceptability of an Individual Internet Intervention (III) embedded and integrated into an Internet Support Group (ISG) with the ultimate goal of enhancing adherence and learning, compared to an individual internet invention alone.
Thirty-one post-treatment cancer survivors were randomized in groups of seven to nine to either the 8-week III+ISG intervention or the 8-week III condition. Seventeen participants met HADS criteria for depressive symptoms (HADS>=8).
Among all participants, the mean number of logins over 8 weeks was 20.8±17.7 logins for the III+ISG compared to 12.5±12.5 in III-only (p=0.15). Two participants in the III+ISG dropped out, compared to 5 in III (p=0.39). Among the 17 participants with depressive symptoms at baseline, both the Onward and the III-only condition showed large reductions in the HADS-dep (d=1.27 & 0.89, respectively). Improvement over time and time×treatment effects only reached trend significance levels (ps=0.07 & 0.12) as this pilot was not powered to detect these differences.
Both the III+ISG and III-only demonstrated pre-post reductions in depressive symptoms and high rates of utilization compared to other web-based treatments for depression. While it is premature to make any determination as to the efficacy of the interventions tested in this feasibility study, these results indicate that pursuing the III+ISG model as well as standard IIIs, may be fruitful areas of future research.
PMCID: PMC3387296  PMID: 22438297
Cancer; Oncology; E-health; Internet; Depression; Collaborative Learning
3.  Associations between cognitive impairment in advanced cancer patients and psychiatric disorders in their caregivers 
Psycho-oncology  2012;22(4):952-955.
This study examined whether cognitive impairment in advanced cancer patients is associated with a heightened frequency of psychiatric disorders in their primary caregivers.
356 patient-caregiver dyads were interviewed and administered the SPMSQ (Short Portable Mental Status Questionnaire) and the Structured Clinical Interview of the Diagnostic and Statistical Manual of Mental Disorder Fourth Edition (SCID) approximately 3.4 months before the patient's death. The SCID was administered to caregivers again approximately 6 months after the patient's death.
46 (12.9%) patients displayed signs of mild cognitive impairment at the baseline interview. After adjustment for relevant confounders, patient cognitive impairment was significantly associated with caregiver pre-loss major depressive disorder (MDD) [OR 6.88 (95% CI 1.32–35.92); p=0.02], without associated increases in suicidality. There were no significant associations between patient cognitive impairment and caregiver pre-loss generalized anxiety disorder, posttraumatic stress disorder, panic disorder, or grief. Likewise, there were no significant associations between patient cognitive impairment and caregiver post-loss psychiatric disorders, but caregivers of cognitively impaired patients appeared to be less satisfied with the patient's manner of death (p=0.01).
Caregivers of cognitively impaired advanced cancer patients appear at heightened risk of major depression that resolves after the patient's death. Further study with a larger sample and more sensitive longitudinal cognitive measures is indicated.
PMCID: PMC3391537  PMID: 22451155
cancer; oncology; caregiver; cognitive impairment; depression; psychiatric disorder
4.  Factors associated with breast cancer worry three years after completion of adjuvant treatment 
Psycho-oncology  2012;22(4):936-939.
Although many survivors continue to worry about cancer years after completing treatment, little is known about factors associated with cancer worry. This study examined associations between breast cancer worry and demographic and clinical variables, as well as fatigue, symptom burden, and risk perception in a sample of breast cancer survivors three years post-adjuvant treatment. We hypothesized that after controlling for demographic and treatment factors, a significant proportion of variance in cancer worry would be explained by greater fatigue severity, more symptom burden, and greater perceived risk of recurrence.
Stage 0–II breast cancer patients (N = 202) completed measures of risk perception, cancer worry (modified Lerman's Cancer Worry Scale), symptom burden (Memorial Symptom Assessment Scale), and fatigue severity (Fatigue Symptom Inventory) three years after completing adjuvant treatment. Multiple regression analyses were used to determine the proportion of variance in cancer worry accounted for by fatigue, symptom burden, and risk perception after controlling for demographic and clinical variables.
Age, fatigue, symptom burden, and risk perception each explained a significant proportion of variance in cancer worry (p < .05). Fatigue, symptom burden, and risk perception together accounted for 27% of the variance in cancer worry after controlling for demographic and clinical factors (p < .01).
The hypothesis was supported that fatigue, symptom burden, and risk perception are associated with cancer worry among breast cancer survivors. It is possible that lingering fatigue and other symptoms may remind breast cancer survivors of their disease.
PMCID: PMC3392435  PMID: 22419546
breast cancer; worry; fatigue; symptom burden; risk perception; survivorship
5.  Feasibility and Value of PatientViewpoint: A Web System for Patient-Reported Outcomes Assessment in Clinical Practice 
Psycho-oncology  2012;22(4):895-901.
The PatientViewpoint website collects patient-reported outcomes (PROs) and links them with the electronic health record to aid patient management. This pilot-test evaluated PatientViewpoint’s use, usefulness, and acceptability to patients and clinicians.
This was a single-arm prospective study that enrolled breast and prostate cancer patients undergoing treatment and the clinicians who managed them. Patients completed PROs every two weeks, and clinicians could access the results for patient visits. Scores that were poor relative to norms or substantially worse than the previous assessment were highlighted. After three on-study visits, we assessed patient and clinician perspectives on PatientViewpoint using close-ended and open-ended questions.
11/12 eligible clinicians (92%) and 52/76 eligible patients (68%) enrolled. Patients completed a median of 71% of assigned questionnaires; clinicians reported using the information for 79% of patients, most commonly as a source of additional information (51%). At the median, score reports identified 3 potential issues, of which 1 was discussed during the visit. Patients reported the system was easy to use (92%), useful (70%), aided recall of symptoms/side effects (72%), helped them feel more in control of their care (60%), improved discussions with their provider (49%), and improved care quality (39%). Patients and clinicians desired more information on score interpretation and minor adjustments to site navigation.
These results support the feasibility and value of PatientViewpoint. An ongoing study is using a continuous quality improvement approach to further refine PatientViewpoint. Future studies will evaluate its impact on patient care and outcomes.
PMCID: PMC3415606  PMID: 22544513
6.  Correlates of continued smoking versus cessation among survivors of smoking-related cancers 
Psycho-oncology  2012;22(4):799-806.
We examined correlates of continued smoking versus cessation among a sample of survivors of smoking-related cancers who were actively smoking at the time of cancer diagnosis.
Participants with a history of smoking and a smoking-related cancer diagnosis (lung, oral, pharynx, larynx, esophagus, bladder, stomach, cervix, kidney, pancreas, acute myeloid leukemia) within the past four years were identified in the electronic medical record. We recruited 613 individuals to complete a mail-based survey and received 139 completed surveys (22.7% response rate). We focused on 105 participants who smoked at the time of diagnosis and dichotomized them to having either quit since diagnosis (48.6%; n=51) or continued smoking (51.4%; n=54). We assessed sociodemographics, type of cancer and treatment(s), and psychosocial factors (depressive symptoms, social support, hope, quality of life). We then conducted structured interviews with a subset of 21 survey respondents.
Binary logistic regression indicated that, controlling for age, gender, ethnicity, marital status, and income, factors associated with continued smoking versus cessation included being diagnosed with other smoking-related cancers versus lung or head and neck cancer (OR=11.21, CI 2.85, 44.02) and having significant depressive symptoms (OR=1.25, CI 1.08, 1.45). Qualitative findings highlighted motivators for cessation (impact of being diagnosed with cancer, doctor advice to quit, social influences) and barriers to cessation (hopelessness, stress, addiction).
These findings highlight the need to address depressive symptoms among cancer survivors, particularly those continuing to smoke, and the importance of exploring messages cancer survivors are given regarding the need for cessation post cancer diagnosis.
PMCID: PMC3425712  PMID: 22488864
Smoking; smoking cessation; survivors; depression; cancer; oncology
7.  Long-term Outcomes of the FRESH START Trial: Exploring the Role of Self-efficacy in Cancer Survivors’ Maintenance of Dietary Practices and Physical Activity 
Psycho-oncology  2012;22(4):876-885.
This study examined whether changes in self-efficacy explain the effects of a mailed print intervention on long-term dietary practices of breast and prostate cancer survivors. The relationship between change in self-efficacy and long-term physical activity (PA) also was examined.
Breast and prostate cancer survivors (N=543) from 39 U.S. states and two Canadian provinces participated in the FRESH START intervention trial. Participants were randomly assigned to receive a 10-month program of mailed print materials on diet and PA available in the public domain or a 10-month program of tailored materials designed to increase fruit and vegetable (F&V) intake, decrease fat intake, and/or increase PA. Changes in self-efficacy for F&V intake and fat restriction were analyzed as potential mediators of the intervention’s effects on diet at 2-year follow-up. Because we previously found that change in self-efficacy for PA did not vary by group assignment, the relationship between change in self-efficacy and PA at 2-year follow-up was examined across study conditions.
Results suggest that change in self-efficacy for fat restriction partially explained the intervention’s effect on fat intake (mean indirect effect=-.28), and change in self-efficacy for F&V consumption partially explained the intervention’s effect on daily F&V intake (mean indirect effect=.11). Change in self-efficacy for fat restriction partially accounted for the intervention’s impact on overall diet quality among men only (mean indirect effect=.60). Finally, change in self-efficacy for PA predicted PA at 2-year follow-up.
Findings suggest that self-efficacy may influence long-term maintenance of healthy lifestyle practices among cancer survivors.
PMCID: PMC3429767  PMID: 22544562
cancer; oncology; survivors; diet; physical activity; randomized controlled trial
8.  Cognitive Features Ten or More Years After Successful Breast Cancer Survival: Comparisons Across Types of Cancer Interventions 
Psycho-oncology  2012;22(4):862-868.
The present study examined the long-term cognitive implications of cancer treatment among breast cancer survivors aged 65 years and older. Fifty-seven women survivors were compared to 30 healthy older female adult comparisons, matched in terms of age and education, with no history of cancer. Cancer survivors were also compared based on treatment intervention, involving chemotherapy (n = 27) versus local therapy through surgery and radiation (n = 30). As a group, the breast cancer survivors scored lower on measures of general cognitive function, working memory, psychomotor speed, and executive function, when compared to the normal comparisons. Among the cancer survivors, those who received local therapy scored lower than the other survivors and normal comparisons on measures of verbal learning, visual perception and construction, as well as visual attention and short-term retention. Our findings suggest that cognitive outcomes may involve more age-related deficits among older cancer survivors compared to matched healthy subjects.
PMCID: PMC3475736  PMID: 22585465
breast cancer; chemotherapy; cognition; neuropsychological assessment
9.  Economic Survivorship Stress is Associated with Poor Health-Related Quality of Life among Distressed Survivors of Hematopoietic Stem Cell Transplantation 
Psycho-oncology  2012;22(4):911-921.
Hematopoietic stem cell transplantation (HSCT) is a demanding cancer treatment associated with enduring physical and psychological complications. Survivors' well-being may be further compromised by exposure to chronic stressors common to this population, including difficulties arising from costly medical care, changes in employment status, and health insurance coverage. Thus, we hypothesized that financial, employment, and insurance stressors (collectively referred to as economic survivorship stressors) would be associated with poorer health-related quality of life (HRQOL) among HSCT survivors.
Survivors (n=181; M=640 days post-transplant) completed measures of study variables through mailed questionnaires and telephone interviews. Hierarchical regression analyses were conducted to test the hypothesized associations between economic survivorship stressors and HRQOL, and to examine whether social and situational factors interact with survivors' stress perceptions to predict HRQOL.
Greater financial and employment stress were associated with poorer functioning across multiple HRQOL domains, even after controlling for the effects of possible confounding sociodemographic and medical variables. Insurance stress was not associated with HRQOL. Some associations were moderated by situational factors including timing of the current financial crisis and portion of the transplant paid for by health insurance.
HSCT survivors can face serious economic challenges during recovery. Results suggest the value of viewing these challenges as chronic stressors capable of reducing survivors' mental and physical well-being. Identifying resources and skills that help survivors cope with these demands is an important goal for clinicians and researchers.
PMCID: PMC3648213  PMID: 22605430
psychological stress; finances; quality of life; stem cell transplantation; cancer survivors; oncology
10.  Development of CBT for chemotherapy-related cognitive change: results of a waitlist control trial 
Psycho-oncology  2010;21(2):176-186.
To evaluate the efficacy of a brief cognitive-behavioral therapy (CBT) that is being developed for management of cognitive dysfunction following chemotherapy among breast cancer survivors. Memory and Attention Adaptation Training (MAAT) is a brief CBT designed to improve the quality of life and function among cancer survivors with post-chemotherapy cognitive complaints.
An initial, two-group (MAAT versus waitlist, no treatment control), randomized clinical trial (RCT) was conducted. Forty stage I and II female breast cancer survivors (mean age = 50; SD = 6.4) were randomized to conditions and assessed at baseline, post-treatment (8 weeks) and 2-month follow-up assessment points on measures of: (1) self-reported daily cognitive failures; (2) quality of life; and (3) neuropsychological performance. Participants were also assessed for satisfaction with MAAT.
With education and IQ as covariates, MAAT participants made significant improvements relative to controls on the spiritual well-being subscale of the quality of life measure and on verbal memory, but statistical significance was not achieved on self-report of daily cognitive complaints. However, moderate-to-large effect sizes were observed on these outcomes. Participants gave MAAT high satisfaction ratings.
Although this initial RCT is a small study, MAAT participants appear to improve on one measure of quality of life and verbal memory performance relative to no treatment controls and rate MAAT with high satisfaction. These data are encouraging and support the continued development and evaluation of MAAT efficacy.
PMCID: PMC3955296  PMID: 22271538
breast cancer; chemotherapy; cognitive dysfunction; cognitive-behavioral therapy; survivorship
11.  Risk perception and cancer worries in families at increased risk of familial breast/ovarian cancer 
Psycho-oncology  2008;17(8):756-766.
While families at increased risk for familial breast/ovarian cancer continue to overestimate their cancer risk with increased cancer worries about the future, few studies have examined factors that affect inherited cancer risk perception and cancer worries in both survivors and unaffected female relatives. The purpose of this study was to examine variables that may affect cancer worries and risk perceptions from a family-based perspective in a racially diverse, community-based, random sample of 146 dyads consisting of adult female breast and/or ovarian cancer survivors and their unaffected female relatives (N = 292). Results indicated that coping style, self-efficacy, partner’s income, family role relationship, and cancer risk perception were significant contributors to the survivors’ and their unaffected relatives’ cancer worries. Significant variables for perception of cancer risk for both survivors and relatives included income, race, family history of cancer, and cancer worries. Relatives had a higher perception of cancer risk, whereas survivors had more cancer worries. Additionally, the level of cancer worries reported by one member of the dyad was related to the amount of worries reported by the other. The results from this study underscore the importance of clinicians addressing concerns of both affected and unaffected members of families at increased risk of cancer to assist them in managing cancer worries and having realistic risk appraisals to make informed decisions about their own and their family’s health surveillance options.
PMCID: PMC3947579  PMID: 18613300
cancer; oncology; risk perception; cancer worries; family
12.  The relationships among knowledge, self-efficacy, preparedness, decisional conflict and decisions to participate in a cancer clinical trial 
Psycho-oncology  2012;22(3):481-489.
Cancer clinical trials (CCTs) are important tools in the development of improved cancer therapies; yet, participation is low. Key psychosocial barriers exist that appear to impact a patient’s decision to participate. Little is known about the relationship among knowledge, self efficacy, preparation, decisional conflict, and patient decisions to take part in CCTs.
The purpose of this study was to determine if preparation for consideration of a CCT as a treatment option mediates the relationship between knowledge, self-efficacy, and decisional conflict. We also explored whether lower levels of decisional conflict are associated with greater likelihood of CCT enrollment.
In a pre-post test intervention study, cancer patients (N=105) were recruited before their initial consultation with a medical oncologist. A brief educational intervention was provided to all patients. Patient self-report survey responses assessed knowledge, self efficacy, preparation for clinical trial participation, decisional conflict, and clinical trial participation.
Preparation was found to mediate the relationship between self-efficacy and decisional conflict (p=0.003 for a test of the indirect mediational pathway for the Decisional Conflict total score). Preparation had a more limited role in mediating the effect of knowledge on decisional conflict. Further, preliminary evidence indicated that reduced decisional conflict was associated with increased clinical trial enrollment (p=0.049).
When patients feel greater CCT self-efficacy and have more knowledge they feel more prepared to make a CCT decision. Reduced decisional conflict, in turn, is associated with the decision to enroll in a clinical trial. Our results suggest that preparation for decision making should be a target of future interventions to improve participation in CCTs.
PMCID: PMC3374030  PMID: 22331643
cancer; oncology; clinical trials; preparation; decision-making; self-efficacy
13.  Randomized Clinical Trial of a Brief and Extensive Dyadic Intervention for Advanced Cancer Patients and Their Family Caregivers 
Psycho-oncology  2012;22(3):555-563.
Few intervention programs assist patients and their family caregivers to manage advanced cancer and maintain their quality of life (QOL). This study examined: 1) whether patient-caregiver dyads (i.e., pairs) randomly assigned to a Brief or Extensive dyadic intervention (the FOCUS Program) had better outcomes than dyads randomly assigned to usual care, and 2) if patients' risk for distress (RFD) and other factors moderated the effect of the Brief or Extensive Program on outcomes.
Advanced cancer patients and their caregivers (N=484 dyads) were stratified by patients' baseline risk for distress (high versus low), cancer type (lung, colorectal, breast, prostate), and research site, and then randomly assigned to a Brief (3-session) or Extensive (6-session) intervention or Control. The interventions offered dyads information and support. Intermediary outcomes were: appraisals (i.e., appraisal of illness/caregiving, uncertainty, hopelessness) and resources (i.e., coping, interpersonal relationships, and self-efficacy). The primary outcome was QOL. Data were collected prior to intervention and post-intervention (3 and 6 months from baseline). The final sample was 302 dyads. Repeated Measures MANOVA was used to evaluate outcomes.
Significant Group by Time interactions showed there was improvement in dyads' coping (p<.05), self-efficacy (p<.05), and social QOL (p<.01), and in caregivers' emotional QOL (p<.05). Effects varied by intervention dose. Most effects were found at 3 months only. Risk for distress accounted for very few moderation effects.
Both Brief and Extensive programs had positive outcomes for patient-caregiver dyads, but few sustained effects. Patient-caregiver dyads benefit when viewed as the “unit of care.”
PMCID: PMC3387514  PMID: 22290823
Oncology; cancer; randomized clinical trial; family caregiver; advanced cancer; quality of life; intervention dose; risk for distress
14.  Exercise and Dietary Change after Diagnosis and Cancer-related Symptoms in Long-term Survivors of Breast Cancer: CALGB 79804 
Psycho-oncology  2009;18(2):128-133.
Improving diet and exercise can reduce survivors' risk of cancer-related fatigue, poor physical functioning, and potentially recurrence. A cancer diagnosis can represent a “teachable moment,” leading survivors to make positive changes in diet and exercise behaviors; however, little is known about how often this occurs or about factors that enhance or limit survivors' ability to make these changes. This cross-sectional descriptive study investigated both the prevalence and clustering of self-reported changes in diet and exercise and how these changes related to ongoing cancer-related symptoms, social support, and stressful life events among long-term breast cancer survivors.
Survivors (n=227, response rate=72%) of a prior Cancer and Leukemia Group B treatment trial, on average 12 years post-diagnosis, completed a mailed survey assessing health behavior changes since diagnosis and current symptoms, social support, and stressful life events.
Over half of survivors reported making positive exercise or diet changes since diagnosis: over 25% reported making exercise and diet changes. ANCOVA models showed that survivors who reported increasing their exercise also reported lower fatigue. Trends were also found between increased fruit and vegetable intake and decreased fatigue and between increased exercise and increased social support.
These results underscore the need for health promotion efforts among survivors. Exercise promotion is especially needed since more survivors attempted to change dietary behaviors than exercise on their own. Further, fatigue may limit survivors' ability to change their health behaviors; alternatively, survivors who increase their exercise may experience less fatigue.
PMCID: PMC3934632  PMID: 18536022
Cancer; Oncology; Health behaviors; Survivors; Long-term effects
15.  Restorative yoga for women with breast cancer: findings from a randomized pilot study 
Psycho-oncology  2009;18(4):360-368.
Restorative yoga (RY) is a gentle type of yoga that may be beneficial for cancer patients and post-treatment survivors. Study goals were: to determine the feasibility of implementing a RY intervention for women with breast cancer; and to examine group differences in self-reported emotional, health-related quality of life, and symptom outcomes.
Women with breast cancer (n = 44; mean age 55.8 years) enrolled in this study; 34% were actively undergoing cancer treatment. Study participants were randomized to the intervention (10 weekly 75-minute RY classes) or a waitlist control group. Participants completed questionnaires at Week 0 (baseline) and Week 10 (immediately post-intervention for the yoga group).
Group differences favoring the yoga group were seen for mental health, depression, positive affect, and spirituality (peace/meaning). Significant baseline * group interactions were observed for negative affect and emotional well-being. Women with higher negative affect and lower emotional well-being at baseline derived greater benefit from the yoga intervention compared to those with similar values at baseline in the control group. The yoga group demonstrated a significant within-group improvement in fatigue; no significant difference was noted for the control group.
Although limited by sample size, these pilot data suggest potential benefit of RY on emotional outcomes and fatigue in cancer patients. This study demonstrates that a RY intervention is feasible for women with breast cancer; implications for study design and implementation are noted with an emphasis on program adoption and participant adherence.
PMCID: PMC3930083  PMID: 19242916
yoga; mind-body; cancer; oncology; well-being
16.  Applying a Conceptual Model for Examining Health-Related Quality of Life in Long-Term Breast Cancer Survivors: CALGB Study 79804 
Psycho-oncology  2008;17(11):1108-1120.
The Survivor’s Health and Reaction (SHARE) study used a quality of life model adapted for cancer survivors by Dow, Ferrell and colleagues to identify factors related to global health-related quality of life (HRQL) and the prevalence of problems and healthy behaviors in breast cancer patients who participated in CALGB 8541. A total of 245 survivors (78% of those invited) who were 9.4 to 16.5 years post-diagnosis completed surveys that inquired about current HRQL, economic, spiritual, physical and psychosocial concerns, and health behaviors, (e.g. smoking, exercise, and supplement use). A regression model developed to characterize global self-assessment of HRQL from all domains showed a negative effect on global HRQL from lower social support (OR=1.03, 95% CI: 1.02, 1.05), having heart disease (OR=5.01, 95% CI: 1.39, 18.1), decreased energy (OR=1.05, 95% CI: 1.03, 1.07), and having 2 or more co-morbidities (OR=2.39, 95%CI: 1.10,5.19). Some women reported engaging in healthy behaviors since their cancer diagnosis, such as increasing exercise (31%), and reducing/quitting smoking (20%). The most prevalent problem reported was menopausal symptoms (59%). Although breast cancer survivors reported making positive lifestyle changes, physical and social factors, such as heart disease, decreased social support and having 2 or more comorbidities were found to be significantly related to HRQL. Factors related to psychological, spiritual and economic domains were not predictive of global HRQL. Suggestions are provided for areas in which to target interventions in order to improve HRQL in long-term breast cancer survivors.
PMCID: PMC3930158  PMID: 18314912
17.  Effect of socioeconomic status as measured by education level on survival in breast cancer clinical trials 
Psycho-oncology  2011;22(2):315-323.
This paper aims to investigate the effect of socioeconomic status, as measured by education, on the survival of breast cancer patients treated on 10 studies conducted by the Cancer and Leukemia Group B.
Sociodemographic data, including education, were reported by the patient at trial enrollment. Cox proportional hazards model stratified by treatment arm/study was used to examine the effect of education on survival among patients with early stage and metastatic breast cancer, after adjustment for known prognostic factors.
The patient population included 1020 patients with metastatic disease and 5146 patients with early stage disease. Among metastatic patients, factors associated with poorer survival in the final multivariable model included African American race, never married, negative estrogen receptor status, prior hormonal therapy, visceral involvement, and bone involvement. Among early stage patients, significant factors associated with poorer survival included African American race, separated/widowed, post/perimenopausal, negative/unknown estrogen receptor status, negative progesterone receptor status, >4 positive nodes, tumor diameter >2 cm, and education. Having not completed high school was associated with poorer survival among early stage patients. Among metastatic patients, non-African American women who lacked a high school degree had poorer survival than other non-African American women, and African American women who lacked a high school education had better survival than educated African American women.
Having less than a high school education is a risk factor for death among patients with early stage breast cancer who participated in a clinical trial, with its impact among metastatic patients being less clear. Post-trial survivorship plans need to focus on women with low social status, as measured by education.
PMCID: PMC3920288  PMID: 22021121
breast cancer; oncology; education; survival; SES
18.  Are the Psychological Needs of Adolescent Survivors of Pediatric Cancer Adequately Identified and Treated? 
Psycho-oncology  2012;22(2):447-458.
To describe the psychological needs of adolescent survivors of acute lymphoblastic leukemia (ALL) or brain tumor (BT), we examined: (a) the occurrence of cognitive, behavioral, and emotional concerns identified during a comprehensive psychological evaluation, and (b) the frequency of referrals for psychological follow-up services to address identified concerns.
Psychological concerns were identified on measures according to predetermined criteria for 100 adolescent survivors. Referrals for psychological follow-up services were made for concerns previously unidentified in formal assessment or not adequately addressed by current services.
Most survivors (82%) exhibited at least one concern across domains: behavioral (76%), cognitive (47%), and emotional (19%). Behavioral concerns emerged most often on scales associated with executive dysfunction, inattention, learning, and peer difficulties. CRT was associated with cognitive concerns, χ2(1,N=100)=5.63, p<0.05. Lower income was associated with more cognitive concerns for ALL survivors, t(47)=3.28, p<0.01, and more behavioral concerns for BT survivors, t(48)=2.93, p<0.01. Of survivors with concerns, 38% were referred for psychological follow-up services. Lower-income ALL survivors received more referrals for follow-up, χ2(1,N=41)=8.05, p<0.01. Referred survivors had more concerns across domains than non-referred survivors, ALL: t(39)=2.96, p<0.01, BT: t(39)=3.52, p<0.01. Trends suggest ALL survivors may be at risk for experiencing unaddressed cognitive needs.
Many adolescent survivors of cancer experience psychological difficulties that are not adequately managed by current services, underscoring the need for long-term surveillance. In addition to prescribing regular psychological evaluations, clinicians should closely monitor whether current support services appropriately meet survivors’ needs, particularly for lower-income survivors and those treated with CRT.
PMCID: PMC3360126  PMID: 22278930
cancer; oncology; psychological; children
19.  A Pilot Study of a Physical Activity Intervention Targeted towards Women at Increased Risk for Breast Cancer 
Psycho-oncology  2011;22(2):381-387.
To pilot test a physical activity intervention targeted towards women with a first-degree relative with breast cancer.
Sedentary women (n=27) with at least 1 first-degree relative with breast cancer but no personal breast cancer diagnosis received a print-based physical activity intervention. The intervention was a 12-week theory-based and individually tailored physical activity intervention targeted towards women with a family history of breast cancer. Participants' minutes of physical activity, worry about breast cancer, perceived risk of developing breast cancer and perceived control over breast cancer risk were assessed at baseline and 12-weeks.
There was a significant increase in minutes of moderate to vigorous intensity physical activity from baseline to 12 weeks (t=4.93, p<.001), with a mean increase in physical activity of 130.56 min/week (sd=137.50). At 12 weeks, 41% met ACSM criteria of engaging in 150 minutes or more of moderate intensity activity. Regression models indicate that change in perceived risk of breast cancer was significantly associated with change in physical activity (t=− 2.36, p=0.03, r=.34), with decreases in perceived risk associated with increases in physical activity over time.
Findings suggest that a targeted intervention can increase physical activity and decrease perceived risk of breast cancer.
PMCID: PMC3368094  PMID: 22135183
Physical activity; intervention; breast cancer risk; Cancer; Oncology
20.  Brief Report: Un Abrazo Para la Familia: Providing Low-Income Hispanics with Education and Skills in Coping with Breast Cancer and Caregiving 
Psycho-oncology  2011;22(2):470-474.
Un Abrazo Para La Familia [A Hug for the Family] is an intervention designed to increase the accessibility of cancer information to low-income and medically underserved co-survivors of cancer. Co-survivors are family members or friends of an individual diagnosed with cancer. Our goal was to increase socio-emotional support for co-survivors, and improve skills in coping with cancer. The purpose of our pilot study was to explore the effectiveness of the intervention in increasing cancer knowledge and self-efficacy among co-survivors.
Un Abrazo consisted of three one-hour sessions, in either Spanish or English. Sessions were delivered by a trained promotora [community health worker], in partnership with a counselor. Sixty participants completed measures of cancer knowledge and self-efficacy preceding (pre-test) and following the intervention (post-test).
From pre- to post-test, the percentage of questions answered correctly about cancer knowledge increased (p < .001), as did ratings of self-efficacy (p < .001). Decreases were seen in “Do not know” responses for cancer knowledge (p < .01), with a negative correlation between number of “Do not knows” on cancer knowledge at pre-test and ratings of self-efficacy at pre-test (r = −.47, p < .01).
When provided an accessible format, co-survivors of cancer from underserved populations increase their cancer knowledge and self-efficacy. This is notable because research indicates that family members and friends with increased cancer knowledge assume more active involvement in the cancer care of their loved ones.
PMCID: PMC3563927  PMID: 22140003
low-income; Hispanic; cancer knowledge; oncology; co-survivors; self-efficacy
Psycho-oncology  2011;22(2):434-440.
Studies of PTSD document a significant proportion of cancer survivors reporting severe posttraumatic stress (PTS) symptoms, even when they do not meet full diagnostic criteria. However, few studies have directly examined the clinical significance of these “partial-PTSD” symptoms in survivors. This study aimed to investigate the prevalence of PTSD symptoms in a cohort of long-term survivors of HL, and to explore the clinical relevance of the partial-PTSD phenomenon by assessing impairment of function secondary to sub-threshold symptomatology.
The Posttraumatic Diagnostic Scale (PDS), was completed by 105 HL survivors and 101 sibling controls. Survivors age at time of participation ranged from 24–71 years, age at time of diagnosis ranged from 6–61 years, and the median time since diagnosis was 16 years (range = 7 – 34).
PTSD prevalence was not significantly higher in HL survivors (13%) compared to sibling controls (6.9%, p = .098). However, a significantly larger proportion of survivors (35.2%) met criteria for partial-PTSD compared to siblings (17.8%, p = .004). Moreover, the majority of the survivors with partial-PTSD (86.5%) reported experiencing some functional impairment related to these PTS symptoms.
A significant number of HL survivors experience PTS symptoms severe enough to result in functional impairment. These findings underscore the importance of future research detailing the psychological and functional outcomes in survivors with partial-PTSD, and of careful clinical practice that assesses for functional impairment secondary to partial-PTSD symptomatology, in male and female survivors, even years after completion of therapy.
PMCID: PMC3908687  PMID: 22162210
Hodgkin’s Lymphoma; Long-Term Survivors; Posttraumatic Stress; Survey; Cancer; Oncology
22.  Predictors of posttraumatic growth in women with breast cancer 
Psycho-oncology  2013;22(12):10.1002/pon.3298.
Posttraumatic growth (PTG) is defined as ‘positive psychological change experienced as a result of a struggle with highly challenging life circumstances’. The current study examined change in PTG over 2 years following breast cancer diagnosis and variables associated with PTG over time.
Women recently diagnosed with breast cancer completed surveys within 8 months of diagnosis and 6, 12, and 18 months later. Linear mixed effects models were used to assess the longitudinal effects of demographic, medical, and psychosocial variables on PTG as measured by the Posttraumatic Growth Inventory (PTGI).
A total of 653 women were accrued (mean age = 54.9, SD = 12.6). Total PTGI score increased over time mostly within the first few months following diagnosis. In the longitudinal model, greater PTGI scores were associated with education level, longer time since diagnosis, greater baseline level of illness intrusiveness, and increases in social support, spirituality, use of active–adaptive coping strategies, and mental health. Findings for the PTGI domains were similar to those for the total score except for the Spiritual Change domain.
PTG develops relatively soon after a breast cancer diagnosis and is associated with baseline illness intrusiveness and increases in social support, spirituality, use of active–adaptive coping strategies, and mental health.
PMCID: PMC3884903  PMID: 24136875
23.  Posttraumatic Growth, Social Support and Social Constraint in Hematopoietic Stem Cell Transplant Survivors 
Psycho-oncology  2011;22(1):195-202.
The relation between posttraumatic growth (PTG) and aspects of the social context, such as social support and social constraint, continues to be unclear in cancer survivors. Social-cognitive processing theory is a useful framework for examining the effect of the social context on PTG. In theory, support interactions may either facilitate or hinder cognitive processing and thus lead to different PTG outcomes. The current study tested the hypothesis that emotional support and instrumental support would each explain a unique amount of the variance in PTG in distressed hematopoietic stem cell transplant (HSCT) survivors. Additionally, it was predicted that social constraint on cancer-related disclosure would be negatively with PTG.
Forty-nine distressed HSCT survivors with a spouse or partner completed the posttraumatic growth inventory (PTGI) and measures of social support received from their spouse/partner and social constraint from people close to them as part of a larger clinical trial.
Both emotional and instrumental social support were positively correlated with PTG and social constraint on disclosure was not associated with PTG. Contrary to hypotheses, instrumental support was the only unique social contextual predictor of PTG. Conclusions: The results of this study highlighted the importance of examining the effects of subtypes of social support on PTG separately. Findings are discussed in the context of the cognitive (i.e. processing of the traumatic event) versus non-cognitive (i.e. buffering stress) pathways between the social context and PTG. Future research directions are presented.
PMCID: PMC3760719  PMID: 21972000
cancer; oncology; posttraumatic growth; social support; social constraint
24.  Personality predicts prostate cancer treatment decision-making difficulty and satisfaction 
Psycho-oncology  2009;18(3):10.1002/pon.1385.
Prostate cancer (PCa) patients often must decide between several treatment modalities considered equally efficacious, but associated with different benefits and side-effects. For some, the decision-making process can be difficult, but little is known about patient characteristics and cognitive processes that might influence the difficulty of such decisions. This study investigated the roles of dispositional optimism and self-efficacy in PCa treatment decision-making difficulty and satisfaction.
One hundred and twenty-five patients with clinically localized PCa completed a mail-in paper-and-pencil survey after they had made their treatment decision, but prior to treatment.
After adjusting for covariates, optimism and treatment decision-making self-efficacy were associated with less difficulty and greater satisfaction with the treatment decision-making process. Effects of optimism on difficulty and satisfaction were partially mediated by self-efficacy for making the treatment decision.
Men with PCa and who are low in optimism may be at greater risk for treatment decision-making difficulty and lack of treatment decision-making satisfaction, in part, because they have lower confidence in their ability to make the decision compared with those who are more optimistic. As self-efficacy perceptions are modifiable, consideration should be given to including self-efficacy enhancing components as part of PCa treatment decision-making interventions.
PMCID: PMC3875290  PMID: 18821530
prostate cancer; treatment decision-making; optimism; self-efficacy; cancer; oncology
25.  Study of dyadic communication in couples managing prostate cancer: a longitudinal perspective 
Psycho-oncology  2010;21(1):10.1002/pon.1861.
Cancer patients and partners often report inadequate communication about illness-related issues, although it is essential for mutual support and informal caregiving. This study examined the patterns of change in dyadic communication between patients with prostate cancer and their partners, and also determined if certain factors affected their communication over time.
Using multilevel modeling, this study analyzed longitudinal data obtained from a randomized clinical trial with prostate cancer patients and their partners, to examine their communication over time. Patients and partners (N=134 pairs) from the usual-care control group independently completed baseline demographic assessment and measures of social support, uncertainty, symptom distress, and dyadic communication at baseline, and 4-, 8-, and 12-month follow-ups.
The results indicated that (1) patients and partners reported similar levels of open communication at the time of diagnosis. Communication reported by patients and partners decreased over time in a similar trend, regardless of phase of illness; (2) phase of illness affected couples’ open communication at diagnosis but not patterns of change over time; and (3) couples’ perceived communication increased as they reported more social support, less uncertainty, and fewer hormonal symptoms in patients. Couples’ demographic factors and general symptoms, and patients’ prostate cancer-specific symptoms did not affect their levels of open communication.
Perceived open communication between prostate cancer patients and partners over time is affected by certain baseline and time-varying psychosocial and cancer-related factors. The results provide empirical evidence that may guide the development of strategies to facilitate couples’ interaction and mutual support during survivorship.
PMCID: PMC3875561  PMID: 20967920

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