N/A
N=257
Mychoice: Testing an Interactive mHealth Tool
Conflict · Decisional Conflict
Bottom Line
View on ClinicalTrials.gov: NCT03427177 ↗Enrolled (actual)
257
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Perceived Efficacy in Patient-Physician Interactions (PEPPI) Self-Efficacy Scale- Outcome Measure at Baseline, Post-test and One Month Follow-up — 44.6; 44.0; 44.3; 44.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mychoice (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fox Chase Cancer Center
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Perceived Efficacy in Patient-Physician Interactions (PEPPI) Self-Efficacy Scale- Outcome Measure at Baseline, Post-test and One Month Follow-up |
44.6; 44.0; 44.3; 44.4; 44.8; 44.2 | — |
| SECONDARY CollaboRATE Perceived Shared Decision Making Scale |
3.82; 3.74; 3.76; 3.71; 3.97; 3.69 | — |
| SECONDARY Shared Decision Making (SDM Q-9) Scale |
4.19; 4.09; 4.29; 4.23; 4.78; 4.67 | — |
| SECONDARY Ottawa Decisional Conflict |
32.0; 31.6; 24.5; 26.2; 27.1; 28.7 | — |
| SECONDARY Preparation for Decision Making (PrepDM) Scale |
3.7; 3.7; 3.9; 3.9; 3.9; 3.9 | — |
Summary
Investigators aim to test a culturally diverse and patient guided mHealth decision tool called mychoice, which allows patients to explore their concerns and questions related to clinical trial participation, as well as create a customized and personalized set of questions to enhance patient-provider communication and increase informed decision making. This study employs a mixed-methods approach using both qualitative and quantitative data to evaluate the effectiveness of the mychoice intervention for patients and to explore the provider and organizational factors that impact implementation. A randomized controlled trial will be performed with 270 participants in order to determine the acceptability and feasibility of the intervention, as well as its effects on self-efficacy in discussing clinical trial participation with providers, leading to enhanced informed decision-making. A secondary aim of the study is to evaluate the implementation of the intervention in clinical settings. Implementation evaluation will occur using surveys of medical staff whose patients are participating in the study. These surveys will assess institutional facilitators and barriers to study implementation. Investigators will also conduct cognitive de-briefing interviews after the intervention is completed with key stakeholders at the participating institutions, which will inform a larger implementation study in the future.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or over
- Active diagnosis of invasive cancer (any diagnoses), pre or post chemo/radiation/surgery
- Able to speak and read English
Exclusion Criteria
- Participated in a therapeutic trial in the past
Data sourced from ClinicalTrials.gov (NCT03427177). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.