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N/A N=257 Randomized Single-blind Health Services Research

Mychoice: Testing an Interactive mHealth Tool

Conflict · Decisional Conflict

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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