A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer

Cancer Clinical Trial

Official title:

A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05706610
• Other study ID #: R21CA268945
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: September 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Meghan E McGrady, PhD
• Phone: 513-803-8044
• Email: Meghan.McGrady[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A pilot feasibility randomized clinical trial comparing a tailored intervention to uniform standard of care will be conducted. A total of 40 AYAs with cancer will be randomized to one of the two programs. Data will be collected to explore the hypotheses that the intervention meets pre-established enrollment, retention, fidelity, and data completion feasibility criteria and that AYAs will rate the intervention as easy to use and acceptable.

Description:

The proposed research includes a randomized clinical trial of a tailored adherence-promotion intervention (Tailored Program) as compared to uniform standard of care (Feedback Program) for adolescents and young adults with cancer. Up to 40 adolescents and young adults (AYAs) with cancer will be enrolled in this study. Participants who enroll in this trial will be given an eCAP electronic monitor, a pill bottle with a computer chip in the cap, to store their medication. After using the electronic monitor for 4 weeks to assess baseline adherence, participants who demonstrate non-adherence and have used the electronic monitor without difficulty will be asked to complete pre-treatment questionnaires. Next, participants will be randomly assigned to either the tailored adherence-promotion intervention group (Tailored Program) or the uniform standard of care group (Feedback Program). Participants will be assigned in a 1:1 ratio so that, at the end of the study, an equal number of participants will have been randomized to each group. Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired. Adolescents and young adults will continue to use the electronic monitor to store their medication until approximately a month after their program ends. After their program ends, participants will complete post-treatment questionnaires regarding program usability and acceptability as well as their adherence.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

Inclusion Criteria:

• Patient between 15 and 24 years of age
• Patient diagnosis of cancer
• Patient prescribed oral chemotherapy or prophylactic medication

Exclusion Criteria:

• Patient is not fluent in English
• Patient evidences significant cognitive deficits per medical team
• Patient's medical status or treatment precludes participation per medical team, patient, or caregiver
• Patient demonstrates greater than or equal to 95% adherence during run-in period
• Patient declines to use electronic monitoring device

Related Conditions & MeSH terms

• Adherence, Medication
• Cancer

Intervention

Behavioral:
• Tailored Program
Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data.
• Feedback Program
Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	St Jude Children's Research Hospital	Memphis	Tennessee
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Seattle Children's Hospital, St. Jude Children's Research Hospital, University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment Rate	Percent of approached eligible participants enrolling in the study	End of study enrollment period, approximately 12 months after enrollment initiation
Secondary	Retention Rate	Percent of participants completing all procedures	End of data collection period, approximately 18 months after enrollment initiation
Secondary	Intervention Fidelity: Contact	Percent of enrolled participants who received 4 intervention sessions	End of data collection period, approximately 18 months after enrollment initiation
Secondary	Intervention Fidelity: Length	Percent of enrolled participants for whom all sessions were 30-45 minutes in length	End of data collection period, approximately 18 months after enrollment initiation
Secondary	Intervention Fidelity: Duration	Percent of enrolled participants who completed all 4 intervention sessions during a 8-10 week period	End of data collection period, approximately 18 months after enrollment initiation
Secondary	Intervention Fidelity: Content	Percent of enrolled participants who received all of the planned intervention content as defined in the fidelity checklist	End of data collection period, approximately 18 months after enrollment initiation
Secondary	Assessment Completion	Percent of enrolled participants with complete data	End of data collection period, approximately 18 months after enrollment initiation
Secondary	System Usability Scale	A 10-item rating of usability	4 weeks following treatment completion
Secondary	Adjective Rating Scale	1-item rating of user friendliness	4 weeks following treatment completion
Secondary	Acceptability & Adherence Scale	Rating of behavioral treatment acceptability	4 weeks following treatment completion
Secondary	Medical Adherence Measure	2-item self-report of missed doses	4 weeks following treatment completion
Secondary	Electronically Monitored Medication Adherence	Each participant will be given an electronic monitoring device to store their medication. The electronic monitoring device records each time the device is opened.	Starting 4 weeks prior to treatment initiation and continuing until 4 weeks following treatment completion