Mychoice: Testing an Interactive mHealth Tool

NCT03427177 | Completed Results

• 1 other identifier: 17-8013
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Conflict; Decisional Conflict

Outcome Measures

Primary Outcomes (1)

• Perceived Efficacy in Patient-Physician Interactions (PEPPI) Self-Efficacy Scale- Outcome Measure at Baseline, Post-test and One Month Follow-up

  10-item scale measuring patient confidence in communicating with their physician. Participants respond to each question on a scale of 1 to 5, with 5 representing "very confident,'' and 1 representing "not at all confident." The range of possible scores for the full PEPPI scale is 10 to 50 (50 representing highest patient-perceived self-efficacy).

  Baseline and post-test (both occur on same day, day 1), one month follow-up

Secondary Outcomes (4)

• CollaboRATE Perceived Shared Decision Making Scale

  1 month follow-up

• Shared Decision Making (SDM Q-9) Scale

  1 month follow-up

• Ottawa Decisional Conflict

  Baseline and post-test (both occur on same day, day 1), one month follow-up

• Preparation for Decision Making (PrepDM) Scale

  Post test (day 1)

Study Arms (2)

Treatment

EXPERIMENTAL

Participants randomized to the treatment arm of the study will be given the mychoice tool.

Behavioral: mychoice

Control

NO INTERVENTION

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).

Interventions

mychoice BEHAVIORAL

The mychoice communication tool begins to prepare patients to participate in a personal and tailored discussion with their provider about clinical trials as a potential treatment option. It is also customized to address the concerns of those least likely to participate, instead of providing a more general look at clinical trials- a common trait of other available tools.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or over
• Active diagnosis of invasive cancer (any diagnoses), pre or post chemo/radiation/surgery
• Able to speak and read English

You may not qualify if:

• Participated in a therapeutic trial in the past

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• Merck Sharp & Dohme LLC: collaborator
• University of Pennsylvania: collaborator
• Temple University: collaborator
• Thomas Jefferson University: collaborator

Study Sites (5)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Temple University

Philadelphia, Pennsylvania, 19121, United States

Location

Temple University Health System

Philadelphia, Pennsylvania, 19140, United States

Location

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Results Point of Contact

• Title: Dr. Linda Fleisher
• Organization: Fox Chase Cancer Center

Linda.Fleisher@fccc.edu

215-214-3757

Study Officials

• Linda Fleisher, PhD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

• Sarah Bass, PhD

  Temple

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: February 9, 2018
• Study Start: June 25, 2018
• Primary Completion: January 21, 2020
• Study Completion: February 28, 2020
• Last Updated: January 27, 2021
• Results First Posted: January 12, 2021

Record last verified: 2020-12

Locations

US (5)