Clinical trial NCT06222242: mychoiceTM Implementation With Medical Oncology Patients
Official title: mychoiceTM Implementation in a Real World Clinical Environment - Delivery and Effectiveness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2024-01-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Detailed description: 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 patient in their discussion with their provider about clinical trials as a treatment option over the course of their oncology treatment (Effectiveness).

Our goal is to focus this study with patients who have had their first Medical Oncology Appointment based on a nightly EMR feed. The mychoiceTM link (currently mychoice.kevindurr.com, but will change to mychoice.templehealth.org prior to study launch) will be sent to patients through a REDCap feed where they can review the mychoice tool and voluntarily answer a short 5 question quality improvement (QI) survey about their experience with mychoiceTM. The survey will include a question about their willingness to be contacted regarding the more in-depth effectiveness study. This survey data will only be evaluated at an aggregate level and used for process improvement purposes.

The effectiveness study will be conducted with patients who have used mychoiceTM and have agreed to be contacted by Fox Chase Research Staff as indicated in their response to one of the questions in the QI survey. Our goal is to conduct follow-up with those patients who used mychoiceTM to evaluate the impact of the tool on patients' perceived preparedness to discuss clinical trials with their physician and insights into this decision-making process over six-months during their treatment. In addition, we will assess provider and system barriers and facilitators to implementation of mychoice in real world settings to guide future dissemination and implementation.

There are three levels of evaluation questions in this project and specific aims related to each.

1. Can an evidence-based digital health tool designed to promote discussion about clinical trial participation (mychoiceTM) be easily provided to patients in real time, and will this dissemination approach be acceptable to patients and providers? (Aim 1)
2. For a sub-set of these patients who use the tool and express interest in participating in a follow-up study evaluation, does the tool positively impact their preparation for a discussion about clinical trials participation across their cancer treatment trajectory? (Aim 3. What are the factors (based on Implementation Research frameworks - RE-AIM and Consolidated Framework Implementation Research) that influence the implementation of mychoiceTM in a real world setting that can guide future dissemination and implementation.

Therefore, the aims of this pragmatic, non-randomized, mixed-methods study is to assess the feasibility, acceptability (Aim 1) and effectiveness of the mychoiceTM preparatory tool for patients (Aim 2).

Eligibility criteria: Inclusion Criteria:

18 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

Exclusion Criteria

Doesn't not speak or read English

Patients who do not have a cancer diagnosis

Primary outcomes:
measure: Feasibility to disseminate the mychoice tool to patients
timeFrame: 24 months
measure: Acceptability
timeFrame: 24
measure: Effectiveness
timeFrame: 24 months
Secondary outcomes:
measure: Implementation Factors
timeFrame: 24 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Linda Fleisher, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: