Application of best practice approaches for designing decision support tools: The preparatory education about clinical trials (PRE-ACT) study

Fleisher, Linda; Ruggieri, Dominique G.; Miller, Suzanne M.; Manne, Sharon L.; Albrecht, Terrance L.; Buzaglo, Joanne S.; Collins, Michael; Katz, Michael; Kinzy, Tyler G.; Liu, Tasnuva M.; Manning, Cheri; Charap, Ellen Specker; Millard, Jennifer; Miller, Dawn M.; Poole, David C.; Raivitch, Stephanie; Roach, Nancy; Ross, Eric A.

doi:10.1016/j.pec.2014.04.009

Cited by 33 publications

(29 citation statements)

References 47 publications

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“…A portion of this information is consistent with the recommendations provided by the literature on clinical trials accrual [5,9,54]. However, the choice of topics differed across the trainings, and not all key areas were reported as having been covered.…”

Section: Discussionsupporting

confidence: 54%

Training Programs for Improving Communication about Medical Research and Clinical Trials: A Systematic Review

Occa¹,

Morgan²

2018

Clinical Trials in Vulnerable Populations

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Objectives: The aim of this article is to provide recommendations on the structure, materials, and outcomes that should be adopted for communication training programs designed to improve clinical trial education for patients. Methods:A systematic review of peer-reviewed articles was conducted. A total of 22 studies were included. Several dimensions were analyzed, such as program design, content development, pedagogical tools, content of the program, and the outcomes affected. Results:The trainings described in the articles analyzed generally took the form of workshops and were developed by groups of heterogeneous experts. Trainings used a variety of educational materials and activities often developed by the research team hosting the training. The outcome measures and assessment methods were not consistent among the trainings, which hinders the ability to statistically synthetize findings. Conclusions:Findings from the review point to a number of recommendations for the development of future clinical research communication training programs. Training programs should be developed by a team of experts with a range of expertise and should be organized in the form of workshops. Participants should be able to role-play newly acquired communication skills using standardized patients.

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Section: Discussionsupporting

confidence: 54%

Training Programs for Improving Communication about Medical Research and Clinical Trials: A Systematic Review

Occa¹,

Morgan²

2018

Clinical Trials in Vulnerable Populations

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“…We also based PROGRESS on prior C-SHIP guided work in cancer survivorship [42, 43] and coping. E-health intervention development strategies from the literature were also used to develop PROGRESS components (e.g., survivors' videos, stress management skills training), along with prior research that described application of theory and best practices in the design, development and preliminary testing of multimedia interventions, particularly two projects based on our prior work that developed eHealth platforms designed to support decision making prior to treatment of early stage prostate cancer patients, i.e., Healing Choices for Prostate Cancer [29] and the Prostate Interactive Educational System (PIES) [44], as well as two other projects of our team [28, 45]. …”

Section: Methodsmentioning

confidence: 99%

Development and preliminary testing of PROGRESS: a Web-based education program for prostate cancer survivors transitioning from active treatment

et al. 2015

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Purpose This formative research study describes the development and preliminary evaluation of a theory-guided, on-line multimedia psycho-educational program (PROGRESS) designed to facilitate adaptive coping among prostate cancer patients transitioning from treatment into long-term survivorship. Methods Guided by the Cognitive-Social Health Information Processing Model (C-SHIP) and using health communications best practices, we conducted a two phase, qualitative formative research study with early stage prostate cancer patients (n=29) to inform the web program development. Phase 1 included individual (n=5) and group (n=12) interviews to help determine intervention content and interface. Phase 2 employed iterative user/usability testing (n=12) to finalize the intervention. Interview data were independently coded and collectively analyzed to achieve consensus. Results Survivors expressed interest in action-oriented content on: (1) managing treatment side effects; (2) handling body image and co-morbidities related to overweight/obesity; (3) coping with emotional and communication issues; (4) tips to reduce disruptions of daily living activities, and (5) health skills training tools. Patients also desired the use of realistic and diverse survivor images. Conclusions Incorporation of an established theoretical framework, application of multimedia intervention development best practices, and an evidence-based approach to content and format, resulted in a psycho-educational tool that comprehensively addresses survivors' needs in a tailored fashion. Implications for Cancer Survivors The results suggest that an interactive web-based multimedia program is useful for survivors if it covers the key topics of symptom control, emotional well-being, and coping skills training; this tool has the potential to be disseminated and implemented as an adjunct to routine clinical care.

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“…After we received a CCEP participant's completed survey, we sent a survey to a matched, non-CCEP trial participant.We asked participants to report their financial concerns in the prior 3 months and barriers to clinical trial participation they experienced when considering trial enrollment. The survey contained items from previously validated questions about barriers to clinical trial participation [32][33][34][35][36][37].…”

Section: Survey Datamentioning

confidence: 99%

Financial Burden of Cancer Clinical Trial Participation and the Impact of a Cancer Care Equity Program

et al. 2016

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Introduction. Cancer clinical trial (CT) participation rates are low and financial barriers likely play a role. We implemented a cancer care equity program (CCEP) to address financial burden associated with trial participation. We sought to examine the impact of the CCEP on CT enrollment and to assess barriers to participation. Methods. We used an interrupted time series design to determine trends in CT enrollment before and after CCEP implementation. Linear regression models compared trial enrollment before and after the CCEP. We also compared patient characteristics before and after the CCEP and between CCEP and non-CCEP participants. We surveyed CCEP and non-CCEP participants to compare preenrollment financial barriers. Results. After accounting for increased trial availability and the trends in accrual for prior years, we found that enrollment increased after CCEP implementation (18.97 participants per

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Application of best practice approaches for designing decision support tools: The preparatory education about clinical trials (PRE-ACT) study

Cited by 33 publications

References 47 publications

Training Programs for Improving Communication about Medical Research and Clinical Trials: A Systematic Review

Training Programs for Improving Communication about Medical Research and Clinical Trials: A Systematic Review

Development and preliminary testing of PROGRESS: a Web-based education program for prostate cancer survivors transitioning from active treatment

Financial Burden of Cancer Clinical Trial Participation and the Impact of a Cancer Care Equity Program

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