Evaluating Adaptation of a Cancer Clinical Trial Decision Aid for Rural Cancer Patients: A Mixed-Methods Approach

Pathak, Swati; George, Nerissa; Monti, Denise; Robinson, Kathy; Politi, Mary C.

doi:10.1007/s13187-018-1377-x

Cited by 11 publications

(15 citation statements)

References 27 publications

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“…44 Using decision aids may be one way to support patients in making autonomous, informed decisions rather than deferring to physician recommendations. Ongoing research suggests that decision aids may increase comprehension of trial information and reduce decisional conflict and decisional regret without biassing participant decisions about whether to participate, [45][46][47] though more research is needed in this area. 48 49 Comparative data Participants in this study were motivated by the potential for health benefits and simultaneously expressed concerns over side effects.…”

Section: Accessible Informationmentioning

confidence: 99%

Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial

et al. 2021

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ObjectivesBench to bedside translation of groundbreaking treatments like chimeric antigen receptor T (CAR-T) cell therapy depends on patient participation in early phase trials. Unfortunately, many novel therapies fail to be adequately evaluated due to low recruitment rates, which slows patient access to emerging treatments. Using the Theoretical Domains Framework (TDF), we sought to identify potential patient barriers and enablers to participating in an early phase CAR-T cell therapy trial.DesignWe used qualitative semistructured interviews to identify potential barriers and enablers to patients’ hypothetical participation in an early phase CAR-T cell therapy trial. We used the TDF and directed content analysis to identify relevant domains based on frequency, relevance and the presence of conflicting beliefs.ParticipantsCanadian adult patients diagnosed with haematological malignancies.ResultsIn total, we interviewed 13 participants (8 women, 5 men). Participants ranged in age from 18 to 73 (median=56) and had been living with haematological cancer from a few months to several years. We found participants were unfamiliar with CAR-T cell therapy but wished to know more about treatment safety, efficacy and trial logistics (domains: knowledge, beliefs about consequences). They were motivated by altruistic considerations, though many prioritised personal health benefits despite recognising the goals (ie, establishing safety) of early phase clinical trials (domains: goals, intentions). Every participant valued receiving medical advice from their haematologists and oncologists, though some preferred impartial medical experts to inform their decision making (domain: social influences). Finally, participants indicated that improving access to financial and social supports would improve their trial participation experience (domain: environmental context and resources).ConclusionUsing the TDF allowed us to identify factors that might undermine participation to a CAR-T cell therapy trial and to optimise recruitment processes by considering patient perspectives to taking part in early phase trials.Trial regestration:NCT03765177; Pre-results.

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Section: Accessible Informationmentioning

confidence: 99%

Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial

et al. 2021

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“…Importantly, the usability score indicates adequate usability per measure guidelines, but the observed scores were lower than some usability scores in our past work. 34 This somewhat lower SUS score might be due to participants’ preferences for receiving information on paper. The decision support tool was intended for electronic use to facilitate dissemination and incorporate patients’ clinical characteristics information.…”

Section: Discussionmentioning

confidence: 99%

A Patient Decision Support Tool for Hepatitis C Virus and CKD Treatment

et al. 2019

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Rationale & Objective Patient education and decision support tools could facilitate decisions around the timing of antiviral therapy in patients living with both hepatitis C virus (HCV) infection and chronic kidney disease (CKD). We previously developed a tool through the HELP (Helping Empower Liver and Kidney Patients) study. This article evaluates the preliminary efficacy and usability of the tool among participants with both HCV infection and CKD. Study Design Pre-post study pilot evaluation. Setting & Participants Participants were at least 18 years old, were English speaking, and had a diagnosis of chronic HCV infection and CKD; they were seen in CKD clinics, dialysis units, and/or hepatology and liver transplantation clinics. Intervention Electronic patient decision support tool. Outcomes Participants’ change in knowledge, certainty about choice, decision self-efficacy, patients’ treatment preferences, and tool usability. Results 70 participants were recruited; 56 of 70 (80.0%) completed study procedures. Nearly all (51/56; 91.1%) requested paper-based study procedures despite the electronic design of the tool. Participants reported that they were most worried about the following treatment factors: (1) cost of drugs to treat HCV infection, (2) how their HCV infection affected their CKD, and (3) wait times for a kidney transplant. After using the decision tool, participants had significantly higher HCV infection and CKD knowledge (mean posttest percent of questions answered correctly = 65.74% vs pretest percent of questions answered correctly = 53.44%; P < 0.001) and more certainty about choice (mean posttest = 3.13 vs pretest = 2.65; P = 0.05). There were no significant changes in decision self-efficacy (mean posttest = 86.62 vs pretest = 84.68; P = 0.48). Limitations Single-site pilot study to explore preliminary tool efficacy and usability. Conclusions This study suggests that a decision tool may support informed patient-centered choices among patients with HCV infection and CKD. Future studies should evaluate ways to improve care decisions in a larger sample using both paper-based and electronic materials. Funding Merck & Co, Inc, Kenilworth, NJ. Trial Registration Registered at clinicaltrials.gov with study number NCT03426787 .

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“…16 Online delivery allows for the incorporation of interactive activities, videos, and sound. Limited evidence suggests that decision aids are acceptable and useful for clinical trial decision making in adult cancer [17][18][19] and treatment decisions in childhood cancer. 20 Decision aids also often incorporate a values-clarification exercise that lists the potential benefits and harms of treatment options to encourage decision makers to consider what is most important to them.…”

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Piloting a parent and patient decision aid to support clinical trial decision making in childhood cancer

et al. 2019

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Objective Families of a child with cancer can find the decision to enrol in a clinical trial challenging and often misunderstand key concepts that underpin trials. We pilot tested “Delta,” an online and booklet decision aid for parents with a child with cancer, and adolescents with cancer, deciding whether or not to enrol in a clinical trial. Methods We developed Delta in accordance with the International Patient Decision Aid Standards. We conducted a pre‐post pilot with parents with a child, and adolescents, who had enrolled in a paediatric phase III clinical trial for newly diagnosed acute lymphoblastic leukaemia. Parents (n = 37) and adolescents (n = 3) completed a questionnaire before and after using Delta (either the website or booklet, based on their preference). Results Twenty‐three parents (62.2%) and three adolescents (100%) reviewed the Delta website. Parents rated Delta as highly acceptable in regard to being clearly presented, informative, easy to read, useful, visually appealing, and easy to use. All participants reported that they would recommend Delta to others and that it would have been useful when making their decision. Parents' subjective (Mdiff=10.8, SDdiff = 15.69, P < .001) and objective (OR = 2.25, 95% CI, 1.66‐3.04; P < .001) clinical trial knowledge increased significantly after reviewing Delta. Conclusions To our knowledge, Delta is the first reported decision aid, available online and as a booklet, for parents and adolescents deciding whether or not to enrol in a paediatric oncology clinical trial. Our study suggests that Delta is acceptable, feasible, and potentially useful.

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Evaluating Adaptation of a Cancer Clinical Trial Decision Aid for Rural Cancer Patients: A Mixed-Methods Approach

Cited by 11 publications

References 27 publications

Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial

Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial

A Patient Decision Support Tool for Hepatitis C Virus and CKD Treatment

Piloting a parent and patient decision aid to support clinical trial decision making in childhood cancer

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