mychoiceTM Implementation With Medical Oncology Patients

NCT06222242 | Unknown

• 1 other identifier: 23-8003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pragmatic, non-randomized mixed-methods evaluation study designed to evaluate the feasibility and acceptability of delivering the mychoiceTM tool to new Medical Oncology patients as well as to more deeply explore its value to patients in their discussion with their provider about clinical trials as a treatment option over the course of their oncology treatment (Effectiveness).

Conditions

Cancer

Keywords

cancer

Outcome Measures

Primary Outcomes (3)

• Feasibility to disseminate the mychoice tool to patients

  Assess the feasibility of disseminating the mychoiceTM preparatory tool to all Medical Oncology patients and the acceptability (measured by recommendation to other patients. Patient feasibility will focus on the proportion of patients who receive the mychoiceTM tool and open the web-based intervention (goal 50%).

  24 months

• Acceptability

  Patient acceptability will be measured for those patients who complete a voluntary, anonymous, feedback survey. Patients will rate how much they would recommend the navigation intervention to other patients on a scale of 1 to 5. Acceptability threshold would be met with a mean score of 3.5 or higher across all patients (aggregated data) who complete the feedback form (QI).

  24

• Effectiveness

  Assess the effectiveness and value of the mychoiceTM tool on patients' preparation for the discussion about clinical trials through baseline and 4 monthsurveys and interviews with a selected sample at 2 months. The primary outcome will be to measure the effectiveness of the tool using a modified Ottawa Preparation Scale (PrepDM, 1-5 scale) addressing the effectiveness of the tool to prepare for a discussion with their provider. Based on our previous randomized trial, benchmark for success is mean score of 3.5 or higher across all patients enrolled on the PrepDM measures (or a total score of 62.5).

  24 months

Secondary Outcomes (1)

• Implementation Factors

  24 months

Study Arms (1)

mychoiceTM intervention

EXPERIMENTAL

Single arm study - all participants receive mychoiceTM

Behavioral: mychoiceTM

Interventions

mychoiceTM BEHAVIORAL

mychoiceTM is an online, educational tool designed to help prepare patients for a conversation with their provider about clinical trials as a treatment option. It consists of text, animations, and videos of real cancer patients sharing their experience with clinical trials. It is not meant to be a recruitment tool, but rather a preparatory tool to promote shared decision making between patients and providers.

mychoiceTM intervention

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
• Able to speak and read English
• Medical Oncology patients who have had their initial visit
• Have a cell phone number and/or an email in the electronic medical record

You may not qualify if:

• Doesn't not speak or read English
• Patients who do not have a cancer diagnosis

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Linda Fleisher, PhD, MPH

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Fleisher, PhD, MPH

CONTACT

(215) 728-4066; linda.fleisher@fccc.edu

Zoe Landau, MPH

CONTACT

215-728-5893; zoe.landau@fccc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: January 24, 2024
• Study Start: June 7, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

US (1)