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1.  Patient-reported Symptoms and Quality of Life Integrated into Clinical Cancer Care 
Seminars in oncology nursing  2011;27(3):203-210.
Objectives
To provide an overview of research and practice related to patient-reported symptom and quality of life assessment integrated into clinical care.
Data sources
Literature retrieved through the PUBMED and CINAHL databases.
Conclusion
Assessing and incorporating patient preferences, engaging the patient in self-report and extending the interaction to the place and time favored by the patient are necessary to bring meaning to the term, patient-centered. There is beginning evidence that these approaches can make a difference, improving care quality.
Implications for nursing practice
Oncology nurses no longer need to be constrained by paper symptom checklists. Patient-reported symptom and quality of life information can be electronically collected and simultaneously made available for home and clinical use through the utilization of Web-based programs.
doi:10.1016/j.soncn.2011.04.005
PMCID: PMC3143403  PMID: 21783011
cancer symptoms; quality of life; patient centered care; clinical informatics; patient reported outcomes
2.  Intermittent versus Continuous Androgen Deprivation in Prostate Cancer 
The New England journal of medicine  2013;368(14):1314-1325.
BACKGROUND
Castration resistance occurs in most patients with metastatic hormone-sensitive prostate cancer who are receiving androgen-deprivation therapy. Replacing androgens before progression of the disease is hypothesized to prolong androgen dependence.
METHODS
Men with newly diagnosed, metastatic, hormone-sensitive prostate cancer, a performance status of 0 to 2, and a prostate-specific antigen (PSA) level of 5 ng per milliliter or higher received a luteinizing hormone–releasing hormone analogue and an antiandrogen agent for 7 months. We then randomly assigned patients in whom the PSA level fell to 4 ng per milliliter or lower to continuous or intermittent androgen deprivation, with patients stratified according to prior or no prior hormonal therapy, performance status, and extent of disease (minimal or extensive). The coprimary objectives were to assess whether intermittent therapy was noninferior to continuous therapy with respect to survival, with a one-sided test with an upper boundary of the hazard ratio of 1.20, and whether quality of life differed between the groups 3 months after randomization.
RESULTS
A total of 3040 patients were enrolled, of whom 1535 were included in the analysis: 765 randomly assigned to continuous androgen deprivation and 770 assigned to intermittent androgen deprivation. The median follow-up period was 9.8 years. Median survival was 5.8 years in the continuous-therapy group and 5.1 years in the intermittent-therapy group (hazard ratio for death with intermittent therapy, 1.10; 90% confidence interval, 0.99 to 1.23). Intermittent therapy was associated with better erectile function and mental health (P<0.001 and P = 0.003, respectively) at month 3 but not thereafter. There were no significant differences between the groups in the number of treatment-related high-grade adverse events.
CONCLUSIONS
Our findings were statistically inconclusive. In patients with metastatic hormone-sensitive prostate cancer, the confidence interval for survival exceeded the upper boundary for noninferiority, suggesting that we cannot rule out a 20% greater risk of death with intermittent therapy than with continuous therapy, but too few events occurred to rule out significant inferiority of intermittent therapy. Intermittent therapy resulted in small improvements in quality of life. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00002651.)
doi:10.1056/NEJMoa1212299
PMCID: PMC3682658  PMID: 23550669
3.  Incidence of severe pain in newly diagnosed ambulatory patients with stage IV cancer 
BACKGROUND:
Pain is common among cancer patients.
OBJECTIVE:
To characterize the incidence of severe pain among newly diagnosed patients with stage IV cancer in ambulatory care.
METHODS:
A retrospective cohort of 505 ambulatory oncology patients with newly diagnosed stage IV solid tumours at a comprehensive cancer centre (Dana-Farber Cancer Institute, Boston, Massachusetts, USA) was followed from January 1, 2004, to December 31, 2006. Pain intensity scores were extracted from electronic medical records. The incidence of severe pain was calculated using the maximum monthly pain scores reported at outpatient visits.
RESULTS:
Of the 505 patients included in the present study, 340 (67.3%) were pain-free at the initial visit, 90 (17.8%) experienced mild pain, 48 (9.5%) experienced moderate pain and 27 (5.4%) experienced severe pain. At least one episode of severe pain within one year of diagnosis was reported by 29.1% of patients. Patients with head and neck, gastrointestinal and thoracic malignancies were more likely to experience severe pain compared with patients with other types of cancer (52.6%, 33.9% and 30.5%, respectively). In the multivariable model, patients whose primary language was not English (OR 2.90 [95% CI 1.08 to 7.80]), patients who reported severe pain at the initial visit (OR 9.30 [95% CI 3.72 to 23.23]) and patients with head and neck (OR 10.17 [95% CI 2.87 to 36.00]) or gastrointestinal (OR 4.05 [95% CI 1.23 to 13.35]) cancers were more likely to report severe pain in the following year.
CONCLUSIONS:
The incidence of severe pain was high in ambulatory patients with newly diagnosed stage IV cancer.
PMCID: PMC3465096  PMID: 23061086
Cancer; Electronic health record; Epidemiology; Incidence; Pain intensity; Palliative care; Risk factors
4.  Decision preparation, satisfaction and regret in a multi-center sample of men with newly diagnosed localized prostate cancer 
Patient education and counseling  2012;88(2):262-267.
Objective
To describe relationships between use of the Personal Patient Profile-Prostate (P3P) decision support system and patient characteristics, and perceived preparation for decision making (PrepDM), satisfaction and decisional regret in the context of prostate cancer treatment choice.
Methods
494 men with localized prostate cancer (LPC) were randomized to receive the P3P intervention or usual care and completed pre-treatment, 1-month and 6-month outcome measures. Multivariable linear regression models were fit for each outcome.
Results
Physician consult visits prior to enrollment, race/ethnicity, and use of clinic-provided books were significant predictors of perceived PrepDM at 1-month. Prior Internet use and PrepDM significantly predicted 6-month decision satisfaction. Decisional regret was significantly predicted by demographics, anxiety, PrepDM score, and EPIC bowel domain score at 6-months. Use of P3P did not predict any outcome.
Practice Implications
Information received and used between biopsy and the treatment options consult visit is likely to make a difference in decision satisfaction.
Conclusion
While the P3P intervention did not significantly affect the outcomes, pre-enrollment information and preparation were strong predictors of the 1 and 6-months outcomes. Decision regret was significantly influenced by personal characteristics and post-treatment symptoms/side effects.
doi:10.1016/j.pec.2012.04.002
PMCID: PMC3409298  PMID: 22608696
prostate cancer; randomized trial; Internet; decision making
6.  The Personal Patient Profile-Prostate, Decision Support for Men With Localized Prostate Cancer: A Multi-center Randomized Trial 
Urologic Oncology  2011;null.
OBJECTIVE
The purpose of this trial was to compare usual patient education plus the Internet-based, Personal Patient Profile-Prostate, versus usual education alone, on conflict associated with decision making, plus explore time-to-treatment and treatment choice.
METHODS
A randomized, multi-center clinical trial was conducted with measures at baseline, one and six months. Men with newly diagnosed localized prostate cancer who sought consultation at urology, radiation oncology or multi-disciplinary clinics in four geographically-distinct American cities were recruited. Intervention group participants used the Personal Patient Profile-Prostate, a decision support system comprised of customized text and video coaching regarding potential outcomes, influential factors, and communication with care providers. The primary outcome, patient-reported decisional conflict, was evaluated over time using Generalized Estimating Equations to fit generalized linear models. Additional outcomes, time-to-treatment, treatment choice and program acceptability/usefulness, were explored.
RESULTS
A total of 494 eligible men were randomized (266 intervention; 228 control). The intervention reduced adjusted decisional conflict over time as compared with the control group, for the uncertainty score (estimate −3.61; (confidence interval, −7.01,−0.22) and values clarity (estimate −3.57; confidence interval (−5.85,−1.30) Borderline effect was seen for the total decisional conflict score (estimate −1.75; confidence interval (−3.61,0.11). Time-to-treatment was comparable between groups, while undecided men in the intervention group chose brachytherapy more often than in the control group. Acceptability and usefulness were highly rated.
CONCLUSION
The Personal Patient Profile-Prostate is the first intervention to significantly reduce decisional conflict in a multi-center trial of American men with newly diagnosed localized prostate cancer. Our findings support efficacy of P3P for addressing decision uncertainty and facilitating patient selection of a prostate cancer treatment that is consistent with the patient values and preferences.
doi:10.1016/j.urolonc.2011.10.004
PMCID: PMC3349002  PMID: 22153756
prostate cancer; randomized trial; Internet; decision making; decisional conflict
7.  Concerns of stem cell transplant patients during routine ambulatory assessment 
Background
Stem cell transplant (SCT) is a treatment choice for many hematological malignancies. There is currently a lack of evidence regarding the self-reported concerns of SCT patients before and after SCT.
Aim and design
This exploratory study performed a secondary analysis of self-reported, written concerns of SCT patients before and after transplant to determine patients’ concerns.
Methods
Content analysis of text box entries of SCT patients collected between 2005 and 2007 at the Seattle Cancer Care Alliance. Text box entries were collected as part of symptom assessment using the Electronic Self-Report Assessment – Cancer instrument. The assessment was presented to 137 patients undergoing SCT at two time points: prior to ambulatory visits before any therapy had begun (T1) and at the first visit after hospital discharge following SCT (T2).
Results
Text box entries were made before (n = 52) and after (n = 87) the transplant, resulting in 139 text box entries made by 137 patients representing 133 concerns. Using content analysis, the entries were categorized and ranked according to frequency. After symptom concerns, patients ranked work and financial issues the most frequent concerns prior to SCT. After SCT, symptoms remained the most frequently entered area of concern, followed by survival.
Conclusion
Oncology providers need to assess SCT patients for work and financial concerns before and after transplant. Appropriate and timely referrals may ease the burden of these concerns for patients. Thus, assessment of financial and work concerns by the oncology team should be an integral part of quality health care for patients undergoing SCT.
doi:10.2147/PPA.S38567
PMCID: PMC3540958  PMID: 23319854
self-report; electronic self-report assessment - cancer; cancer; patient concerns
8.  “It’s not like I can change my mind later”: Reversibility and decision timing in prostate cancer treatment decision-making 
Patient education and counseling  2009;77(2):302-307.
OBJECTIVE
To explore whether reversibility, decision timing, and uncertainty are relevant to men deciding on treatment for localized prostate cancer (LPC).
DESIGN
Secondary qualitative data analysis of unstructured interviews.
METHODS
Content analysis of previously collected qualitative data (31 individual interviews, 5 focus groups). We identified the frequency of references to reversibility, decision timing, and uncertainty and related subthemes.
RESULTS
We identified eight themes: reversibility, timing of decision, number of options, “getting it over with,” “the way I make decisions,” uncertainty among experts, desire for certainty, and probability. Fifteen men mentioned reversibility in individual interviews; 13 mentioned the importance of the timing of their decision. Eleven mentioned the importance of the number of options; twelve “the way I make decisions.” Eleven men mentioned the uncertainty of experts, fourteen the desire to “get it over with,” and six a desire for certainty.
CONCLUSION
This study provides compelling preliminary data suggesting that men consider the reversibility, decision timing, and uncertainty in the prostate cancer treatment decision.
PRACTICE IMPLICATION
These findings may be helpful in enhancing support for men facing the treatment decision.
doi:10.1016/j.pec.2009.03.017
PMCID: PMC3509197  PMID: 19386460
prostate cancer; decision-making; reversibility; qualitative research
9.  Phase III Trial of Selenium to Prevent Prostate Cancer in Men with High-Grade Prostatic Intraepithelial Neoplasia: SWOG S9917 
The threat of prostate cancer (PC) and the significant and often negative impact of its treatment underscore the importance of prevention. High-grade prostatic intraepithelial neoplasia (HGPIN) has been identified as a potential premalignant lesion marking an increased risk of PC, and substantial evidence suggests that men with HGPIN are in need of PC prevention. In vitro, in vivo, epidemiologic, and clinical trial evidence that selenium supplementation protects against PC motivated the study we report here: A double-blind, randomized, placebo-controlled trial of selenium 200 (mcg/day) as selenomethionine in men with HGPIN. The primary endpoint was progression of HGPIN to PC over a three-year period. This NCI Intergroup trial was coordinated by the Southwest Oncology Group (SWOG). Of 619 enrolled patients, 423 randomized men with HGPIN (212, selenium; 211, placebo) were eligible (by central pathology review) and included in the primary analysis. Three-year cancer rates were 36.6% (placebo) versus 35.6% (selenium; P = 0.73, adjusted). The majority of patients who developed cancer on trial (70.8%, selenium, and 75.5%, placebo) had a Gleason score of ≤ 6; there were no differences in Gleason scores between the two arms. Subset analyses included the finding of a nonsignificantly reduced PC risk (relative risk = 0.82; 95% confidence interval, 0.40–1.69) in selenium versus placebo patients in the lowest quartile of baseline plasma selenium level (< 106 ng/ml). Overall, and in all other subsets defined by baseline blood selenium levels, selenium supplementation had no effect on PC risk. The 36% PC rate in men with HGPIN indicates the association of this lesion with an elevated PC risk. Future study in this setting should focus on selenium-deficient populations and selenium pharmacogenetics.
doi:10.1158/1940-6207.CAPR-10-0343
PMCID: PMC3208719  PMID: 21896650
Chemoprevention; selenium; prostate cancer; intraepithelial neoplasia; prevention; clinical trials
10.  Factors Associated With Pain Among Ambulatory Patients With Cancer With Advanced Disease at a Comprehensive Cancer Center 
Journal of Oncology Practice  2012;8(4):e17-e23.
Younger age, minority race, and recent onset of advanced disease are associated with severe pain among patients with cancer. Recognizing these high-risk groups could inform targeted interventions to address pain care in ambulatory patients with advanced cancer.
Purpose:
The prevalence and severity of pain have not been well described among oncology patients in ambulatory care. To better understand the burden of pain among patients with advanced cancer, we examined the prevalence of pain reported during office and treatment visits.
Methods:
A retrospective study of 4,014 patients with advanced disease (stage 4 at diagnosis or metastatic progression) who completed an ambulatory visit between 2004 and 2006 was conducted at a comprehensive cancer center in Boston, Massachusetts.
Results:
At their first visit during the study period, 74% of patients reported no pain (0 score); 12%, low pain (1 to 3 score); 9%, moderate pain (4 to 6 score); and 5%, severe pain (7 to 10 score). The prevalence of pain was highest among patients who were younger than 60 years of age, were nonwhite, did not speak English as their primary language, or were covered by Medicaid, received free care, or paid their own health care costs. Patients with thoracic, breast, and head and neck cancers had higher pain scores than those with other diseases. Pain was reported more frequently among patients whose diagnosis or metastatic progression occurred less than 3 months before the reported pain score. In multivariable regression analysis, age, race, cancer type, and time since diagnosis/progression were identified as important factors associated with severe pain.
Conclusion:
Younger age, minority race, and recent onset of advanced disease are associated with severe pain among patients with cancer. Recognizing these high-risk groups could inform targeted interventions to address pain care in ambulatory patients with advanced cancer.
doi:10.1200/JOP.2011.000388
PMCID: PMC3396812  PMID: 23180994
11.  Personal preferences and discordant prostate cancer treatment choice in an intervention trial of men newly diagnosed with localized prostate cancer 
Background
Men diagnosed with localized prostate cancer (LPC) can choose from multiple treatment regimens and are faced with a decision in which medical factors and personal preferences are important. The Personal Patient Profile-Prostate (P3P) is a computerized decision aid for men with LPC that focuses on personal preferences. We determined whether the P3P intervention improved the concordance of treatment choice with self-reported influential side-effects compared with a control group.
Methods
English/Spanish-speaking men diagnosed with LPC (2007–2009) from four US cities were enrolled into a randomized trial and followed through 6-months via mailed or online questionnaire. Men were randomized to receive the P3P intervention or standard education plus links to reputable websites. We classified choice as concordant if men were concerned with (a) sexual function and chose external beam radiotherapy or brachytherapy, (b) bowel function and chose prostatectomy, (c) sex, bowel, and/or bladder function and chose active surveillance, or (d) not concerned with any side effect and chose any treatment. Using logistic regression, we calculated odds ratios (OR) and 95% confidence intervals (CI) for the association between the P3P intervention and concordance.
Results
Of 448 men, most were <65 years, non-Hispanic white, had multiple physician consultations prior to enrollment, and chose a treatment discordant with concerns about potential side effects. There was no significant difference in concordance between the intervention (45%) and control (50%) group (OR = 0.82; 95%CI = 0.56, 1.2).
Conclusions
The P3P intervention did not improve concordance between potential side effects and treatment choice. Information and/or physician consultation immediately after diagnosis was likely to influence decisions despite concerns about side effects. The intervention may be more effective before the first treatment options consultation.
Trial registration
NCT00692653 http://clinicaltrials.gov/ct2/show/NCT00692653
doi:10.1186/1477-7525-10-123
PMCID: PMC3502193  PMID: 23021156
Localized prostate cancer; Randomized trial; Decision making; Treatment; Patient preferences; Quality of life
12.  Enhancing Patient-Provider Communication With the Electronic Self-Report Assessment for Cancer: A Randomized Trial 
Journal of Clinical Oncology  2011;29(8):1029-1035.
Purpose
Although patient-reported cancer symptoms and quality-of-life issues (SQLIs) have been promoted as essential to a comprehensive assessment, efficient and efficacious methods have not been widely tested in clinical settings. The purpose of this trial was to determine the effect of the Electronic Self-Report Assessment–Cancer (ESRA-C) on the likelihood of SQLIs discussed between clinicians and patients with cancer in ambulatory clinic visits. Secondary objectives included comparison of visit duration between groups and usefulness of the ESRA-C as reported by clinicians.
Patients and Methods
This randomized controlled trial was conducted in 660 patients with various cancer diagnoses and stages at two institutions of a comprehensive cancer center. Patient-reported SQLIs were automatically displayed on a graphical summary and provided to the clinical team before an on-treatment visit (n = 327); in the control group, no summary was provided (n = 333). SQLIs were scored for level of severity or distress. One on-treatment clinic visit was audio recorded for each participant and then scored for discussion of each SQLI. We hypothesized that problematic SQLIs would be discussed more often when the intervention was delivered to the clinicians.
Results
The likelihood of SQLIs being discussed differed by randomized group and depended on whether an SQLI was first reported as problematic (P = .032). Clinic visits were similar with regard to duration between groups, and clinicians reported the summary as useful.
Conclusion
The ESRA-C is the first electronic self-report application to increase discussion of SQLIs in a US randomized clinical trial.
doi:10.1200/JCO.2010.30.3909
PMCID: PMC3068053  PMID: 21282548
13.  Validation and testing of the Acceptability E-scale for Web-based patient-reported outcomes in cancer care 
Applied nursing research : ANR  2009;24(1):53-58.
The performance of the Acceptability E-scale was tested in a sample of 627 adult and older adult patients from various oncology clinics who completed an electronic symptoms survey. The revised Acceptability E-scale has strong psychometric properties and can be useful in assessing the acceptability and usability of computerized health-related programs in oncology and other health population.
doi:10.1016/j.apnr.2009.04.003
PMCID: PMC3030937  PMID: 20974066
14.  Development and Evaluation of the Personal Patient Profile-Prostate (P3P), a Web-Based Decision Support System for Men Newly Diagnosed With Localized Prostate Cancer 
Background
Given that no other disease with the high incidence of localized prostate cancer (LPC) has so many treatments with so few certainties related to outcomes, many men are faced with assuming some responsibility for the treatment decision along with guidance from clinicians. Men strongly consider their own personal characteristics and other personal factors as important and influential to the decision. Clinical researchers have not developed or comprehensively investigated interventions to facilitate the insight and prioritizing of personal factors along with medical factors that are required of a man in preparation for the treatment decision.
Objectives
The purpose of this pilot study was to develop and evaluate the feasibility and usability of a Web-based decision support technology, the Personal Patient Profile-Prostate (P3P), in men newly diagnosed with LPC.
Methods
Use cases were developed followed by infrastructure and content application. The program was provided on a personal desktop computer with a touch screen monitor. Participant responses to the query component of P3P determined the content of the multimedia educational and coaching intervention. The intervention was tailored to race, age, and personal factors reported as influencing the decision. Prepilot usability testing was conducted using a “think aloud” interview to identify navigation and content challenges. These issues were addressed prior to deployment in the clinic. A clinical pilot was conducted in an academic medical center where men sought consultation and treatment for LPC. Completion time, missing data, and acceptability were measured.
Results
Prepilot testing included 4 men with a past diagnosis of LPC who had completed therapy. Technical navigation issues were documented along with confusing content language. A total of 30 additional men with a recent diagnosis of LPC completed the P3P program in clinic prior to consulting with a urologist regarding treatment options. In a mean time of 46 minutes (SD 13 minutes), participants completed the P3P query and intervention components. Of a possible 4560 items for 30 participants, 22 (0.5%) were missing. Acceptability was reported as high overall. The sections of the intervention reported as most useful were the statistics graphs, priority information topics, and annotated external website links.
Conclusions
The P3P intervention is a feasible and usable program to facilitate treatment decision making by men with newly diagnosed LPC. Testing in a multisite randomized trial with a diverse sample is warranted.
doi:10.2196/jmir.1576
PMCID: PMC3056527  PMID: 21169159
Prostate cancer; decision making; computer-assisted; pilot study
15.  Depression Screening Using the Patient Health Questionnaire-9 Administered on a Touch Screen Computer 
Psycho-oncology  2009;18(1):14-22.
PURPOSE
To 1) evaluate the feasibility of touch screen depression screening in cancer patients using the Patient Health Questionnaire-9 (PHQ-9), 2) evaluate the construct validity of the PHQ-9 using the touch screen modality, and 3) examine the prevalence and severity of depression using this screening modality.
METHODS
The PHQ-9 was placed in a web-based survey within a study of the clinical impact of computerized symptom and quality of life screening. Patients in medical oncology, radiation oncology, and hematopoietic stem cell transplantation (HSCT) clinics used the program on a touch screen computer in waiting rooms prior to therapy (T1) and during therapy (T2). Responses of depressed mood or anhedonia (PHQ-2 cardinal depression symptoms) triggered additional items. PHQ-9 scores were provided to the oncology team in real-time.
RESULTS
Among 342 patients enrolled, 33 (9.6%) at T1 and 69 (20.2%) at T2 triggered the full PHQ-9 by endorsing at least one cardinal symptom. Feasibility was high, with at least 97% completing the PHQ-2 and at least 96% completing the PHQ-9 when triggered and a mean completion time of about 2 minutes. The PHQ-9 had good construct validity. Medical oncology patients had the highest percent of positive screens (12.9%) at T1, while HSCT patients had the highest percent (30.5%) at T2. Using this method, 21 (6.1%) at T1 and 54 (15.8%) at T2 of the total sample had moderate to severe depression.
CONCLUSION
The PHQ-9 administered on a touch screen computer is feasible and provides valid depression data in a diverse cancer population.
doi:10.1002/pon.1368
PMCID: PMC2610244  PMID: 18457335
cancer; oncology; depression; screening; transplant; computer
16.  Measuring decisional control preferences in men newly diagnosed with prostate cancer 
Journal of Psychosocial Oncology  2011;29(6):606-618.
The Control Preferences Scale is widely used in decision research to measure patient preferences for participation in treatment decision making with health care providers. Following anecdotal reports of confusion with the scale we conducted an exploratory interview study to examine perceptions of the meaning and applicability of the Control Preferences Scale for men with localized prostate cancer seeking treatment in a multidisciplinary urology clinic. Our preliminary data suggest potential validity challenges when the CPS is used in a multidisciplinary prostate cancer care setting, including the clinical context of localized prostate cancer and the meaning of shared decision making.
doi:10.1080/07347332.2011.615383
PMCID: PMC3285491  PMID: 22035534
prostate cancer; qualitative; measurement; multidisciplinary care; measurement interview

Results 1-16 (16)