Seth Wolpin

Enhancing Patient-Provider Communication With the Electronic Self-Report Assessment for Cancer: A Randomized Trial

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.

Randomized Controlled Trial of an Internet-Based Versus Face-to-Face Dyspnea Self-Management Program for Patients With Chronic Obstructive Pulmonary Disease: Pilot Study

Background People with chronic obstructive pulmonary disease (COPD) continue to experience dyspnea with activities of daily living (ADL) despite optimal medical management. Information and communication technologies may facilitate collaborative symptom management and could potentially increase the reach of such interventions to those who are unable to attend face-to-face pulmonary rehabilitation or self-management programs. Objective The purpose of this randomized study was to test the efficacy of two 6-month dyspnea self-management programs, Internet-based (eDSMP) and face-to-face (fDSMP), on dyspnea with ADL in people living with COPD. Methods We randomly assigned 50 participants with moderate to severe COPD who were current Internet users to either the eDSMP (n = 26) or fDSMP (n = 24) group. The content of the two programs was similar, focusing on education, skills training, and ongoing support for dyspnea self-management, including independent exercise. The only difference was the mode (Internet/personal digital assistant [PDA] or face-to-face) in which the education sessions, reinforcement contacts, and peer interactions took place. Participants returned to one of two academic clinical sites for evaluation at 3 and 6 months. The primary outcome of dyspnea with ADL was measured with the Chronic Respiratory Questionnaire. Secondary outcomes of exercise behavior, exercise performance, COPD exacerbations, and mediators, such as self-efficacy and social support, were also measured. A satisfaction survey was administered and a semistructured exit interview was conducted at the final visit. Results The study was stopped early due to multiple technical challenges with the eDSMP, but follow-up was completed on all enrolled participants. Data were available for 39 participants who completed the study (female: 44%; age: 69.5 ± 8.5 years; percent predicted forced expiratory volume in 1 s: 49.6 ± 17.0%). The fDSMP and eDSMP showed similar clinically meaningful changes in dyspnea with ADL from baseline to 3 months (fDSMP: + 3.3 points; eDSMP: + 3.5 points) and sustained these improvements at 6 months (fDSMP: + 4.0 points; eDSMP: + 2.5 points; time effects P < .001; group by time P = .51). Self-reported endurance exercise time (P = .001), physical functioning (P = .04), and self-efficacy for managing dyspnea (P = .02) also showed positive improvements over time in both groups with no significant differences with respect to program modality. Participants who completed the study reported favorable satisfaction with the programs. Conclusions Although there were numerous technical challenges with the eDSMP, both dyspnea self-management programs were effective in reducing dyspnea with ADL in the short term. Our findings will need to be confirmed in a larger randomized trial with more mature Web and personal digital assistant tools, use of a control group, and longer follow-up. Trial registration clinicaltrials.gov NCT00102401, http://www.webcitation.org/5X8CX4gLC

Depression screening using the Patient Health Questionnaire-9 administered on a touch screen computer

Objective: 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.

Pilot study of a cell phone-based exercise persistence intervention post-rehabilitation for COPD

Objective To determine the feasibility and efficacy of a six-month, cell phone-based exercise persistence intervention for patients with chronic obstructive pulmonary disease (COPD) following pulmonary rehabilitation. Methods Participants who completed a two-week run-in were randomly assigned to either MOBILE-Coached (n = 9) or MOBILE-Self-Monitored (n = 8). All participants met with a nurse to develop an individualized exercise plan, were issued a pedometer and exercise booklet, and instructed to continue to log their daily exercise and symptoms. MOBILE-Coached also received weekly reinforcement text messages on their cell phones; reports of worsening symptoms were automatically flagged for follow-up. Usability and satisfaction were assessed. Participants completed incremental cycle and six minute walk (6MW) tests, wore an activity monitor for 14 days, and reported their health-related quality of life (HRQL) at baseline, three, and six months. Results The sample had a mean age of 68 ±11 and forced expiratory volume in one second 18% predicted. Participants reported that logging their exercise and symptoms (FEV1) of 40 ± was easy and that keeping track of their exercise helped them remain active. There were no differences between groups over time in maximal workload, 6MW distance, or HRQL (p > 0.05); however, MOBILE-Self-Monitored increased total steps/day whereas MOBILE-Coached logged fewer steps over six months (p =0.04). Conclusions We showed that it is feasible to deliver a cell phone-based exercise persistence intervention to patients with COPD post-rehabilitation and that the addition of coaching appeared to be no better than self-monitoring. The latter finding needs to be interpreted with caution since this was a purely exploratory study. Trial registration ClinicalTrials.gov (NCT00373932).

Electronic Self-Report Assessment for Cancer and Self-Care Support: Results of a Multicenter Randomized Trial

PURPOSE The purpose of this trial was to evaluate the effect of a Web-based, self-report assessment and educational intervention on symptom distress during cancer therapy. PATIENTS AND METHODS A total of 752 ambulatory adult participants were randomly assigned to symptom/quality-of-life (SxQOL) screening at four time points (control) versus screening, targeted education, communication coaching, and the opportunity to track/graph SxQOL over time (intervention). A summary of the participant-reported data was delivered to clinicians at each time point in both groups. All participants used the assessment before a new therapeutic regimen, at 3 to 6 weeks and 6 to 8 weeks later, completing the final assessment at the end of therapy. Change in Symptom Distress Scale-15 (SDS-15) score from pretreatment to end of study was compared using analysis of covariance and regression analysis adjusting for selected variables. RESULTS We detected a significant difference between study groups in mean SDS-15 score change from baseline to end of study: 1.27 (standard deviation [SD], 6.7) in the control group (higher distress) versus -0.04 (SD, 5.8) in the intervention group (lower distress). SDS-15 score was reduced by an estimated 1.21 (95% CI, 0.23 to 2.20; P = .02) in the intervention group. Baseline SDS-15 score (P < .001) and clinical service (P = .01) were predictive. Multivariable analyses suggested an interaction between age and study group (P = .06); in subset analysis, the benefit of intervention was strongest in those age > 50 years (P = .002). CONCLUSION Web-based self-care support and communication coaching added to SxQOL screening reduced symptom distress in a multicenter sample of participants with various diagnoses during and after active cancer treatment. Participants age > 50 years, in particular, may have benefited from the intervention.

Internet-based dyspnea self-management support for patients with chronic obstructive pulmonary disease

CONTEXT People with chronic obstructive pulmonary disease experience dyspnea with activities despite optimal medical management. OBJECTIVES The purpose of this study was to test the efficacy of two 12-month dyspnea self-management programs (DSMPs), Internet-based (eDSMP) and face-to-face (fDSMP), compared with a general health education (GHE) control on the primary outcome of dyspnea with activities. METHODS Participants with chronic obstructive pulmonary disease were randomized to eDSMP (n=43), fDSMP (n=41), or GHE (n=41). The content of the DSMPs were similar and focused on education, skills training, and coaching on dyspnea self-management strategies, including exercise, and only differed in the delivery mode. Dyspnea with activities was measured with the Chronic Respiratory Questionnaire at three, six, and 12 months. Secondary outcomes included exercise behavior and performance, health-related quality of life, self-efficacy for dyspnea management, and perception of support for exercise. The study was registered at Clinicaltrials.gov (NCT00461162). RESULTS There were no differences in dyspnea with activities across groups over 12 months (P=0.48). With the exception of arm endurance (P=0.04), exercise behavior, performance, and health-related quality of life did not differ across groups (P>0.05). Self-efficacy for managing dyspnea improved for the DSMPs compared with GHE (P=0.06). DSMP participants perceived high levels of support for initiating and maintaining an exercise program. CONCLUSION The DSMPs did not significantly reduce dyspnea with activities compared with attention control. However, the high participant satisfaction with the DSMPs combined with positive changes in other outcomes, including self-efficacy for managing dyspnea and exercise behavior, highlight the need for additional testing of individually tailored technology-enabled interventions to optimize patient engagement and improve clinically relevant outcomes.

The Personal Patient Profile-Prostate decision support for men with localized prostate cancer: A multi-center randomized trial ☆

OBJECTIVE The purpose of this trial was to compare usual patient education plus the Internet-based Personal Patient Profile-Prostate, vs. 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, 1-, and 6 months. Men with newly diagnosed localized prostate cancer (CaP) who sought consultation at urology, radiation oncology, or multi-disciplinary clinics in 4 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 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 CaP. Our findings support efficacy of P3P for addressing decision uncertainty and facilitating patient selection of a CaP treatment that is consistent with the patient values and preferences.

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.

Acceptability of an Electronic Self Report Assessment Program for Patients with Cancer

Eliciting symptom and quality of life information from patients is an important component of medical and nursing care processes. Traditionally, this information has been collected with paper and pencil. However, this approach presents several barriers, including delays in receiving information, difficulty in integrating responses with electronic records, and the time required to manually score questionnaires for measurement purposes. One solution that addresses many of these barriers is the adoption of computerized screening for symptom and quality-of-life information. This research explored the acceptability of asking symptom and quality-of-life questions using the Electronic Self Report Assessment-Cancer program on wireless laptops equipped with touch-screen format. Acceptability data were explored with respect to whether any differences may be attributed to demographics and symptom and quality-of-life levels, such as depression and cognitive and emotional functioning. This evaluation used descriptive and univariate statistics to examine data from 342 participants from the ongoing ESRA-C randomized clinical trial. Research participants for the ESRA-C study were recruited from the Seattle Cancer Care Alliance, a consortium among the University of Washington Medical Center, Fred Hutchinson Cancer Research Center, and Childrens Hospital and Regional Medical Center in Seattle, WA. The sample consisted of 342 adult participants who completed both baseline and follow-up survey sessions. Medical oncology represented the largest recruitment group (45.3%), followed by stem cell transplant (34.5%) and radiation oncology (20.2%). The primary finding was that patients were generally able to use ESRA-C quickly and without difficulty in a real-world clinical setting and that they were overall quite satisfied with the ESRA-C program. Significant differences were found in several acceptability areas with respect to demographics and quality of life measures such as age, sex, and severe distress. This analysis confirms that the ESRA-C application for collecting symptom and quality of life information is easy for patients to use and acceptable across a range of user characteristics. We intend to build on our work by using the survey platform in other modalities while ensuring that the patients preferences are considered at all times.

Validation and testing of the Acceptability E-scale for web-based patient-reported outcomes in cancer care

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.