Clinical trial · Interventional
Mychoice: Testing an Interactive mHealth Tool
Mychoice: Testing an Interactive mHealth Tool to Enhance Communication and Informed Decision Making About Clinical Trial Participation in Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Conflict | — | UNRESOLVED | — |
| Decisional Conflict | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mychoice | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Participants randomized to the treatment arm of the study will be given the mychoice tool.
- interventionNames
- Behavioral: mychoice
- type
- NO_INTERVENTION
- label
- Control
- description
- Participants randomized to the control arm of the study will be given existing literature from the NCI that describes clinical trials (standard information for newly diagnosed cancer patients).
Primary outcomes (1)
- measure
- Perceived Efficacy in Patient-Physician Interactions (PEPPI) Self-Efficacy Scale- Outcome Measure at Baseline, Post-test and One Month Follow-up
- timeFrame
- Baseline and post-test (both occur on same day, day 1), one month follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (38)
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- BACKGROUNDComis R, Crowley J. Baseline study of patient accrual onto publically sponsored U.S. cancer clinical trials: an analysis conducted for the global access project of the national patient advocate foundation, 2006.
- BACKGROUNDMichaels, M.S., S; ENACCT and Community-Campus Partnerships for Health, Communities as Partners in Cancer Clinical Trials: Changing Research, Practice and Policy. 2008: Silver Springs, MD.
- BACKGROUNDWeinberg, A.D. Eliminating Disparities in Clinical Trials. cited 2009 June 4th, 2009; Version 2: Available from: http://www.bcm.edu/edict/home.html.
- BACKGROUNDColon-Otero G, Smallridge RC, Solberg LA Jr, Keith TD, Woodward TA, Willis FB, Dunn AN. Disparities in participation in cancer clinical trials in the United States : a symptom of a healthcare system in crisis. Cancer. 2008 Feb 1;112(3):447-54. doi: 10.1002/cncr.23201. PMID 18085590
- BACKGROUNDGadegbeku CA, Stillman PK, Huffman MD, Jackson JS, Kusek JW, Jamerson KA. Factors associated with enrollment of African Americans into a clinical trial: results from the African American study of kidney disease and hypertension. Contemp Clin Trials. 2008 Nov;29(6):837-42. doi: 10.1016/j.cct.2008.06.001. Epub 2008 Jun 27. PMID 18639652
- BACKGROUNDKatz RV, Wang MQ, Green BL, Kressin NR, Claudio C, Russell SL, Sommervil C. Participation in biomedical research studies and cancer screenings: perceptions of risks to minorities compared with whites. Cancer Control. 2008 Oct;15(4):344-51. doi: 10.1177/107327480801500409. PMID 18813202
- BACKGROUNDShavers VL, Lynch CF, Burmeister LF. Factors that influence African-Americans' willingness to participate in medical research studies. Cancer. 2001 Jan 1;91(1 Suppl):233-6. doi: 10.1002/1097-0142(20010101)91:1+3.0.co;2-8.