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Trial Title:
A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer
NCT ID:
NCT05706610
Condition:
Cancer
Adherence, Medication
Conditions: Keywords:
cancer
adherence
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Tailored Program
Description:
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.
Arm group label:
Tailored Program
Intervention type:
Behavioral
Intervention name:
Feedback Program
Description:
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.
Arm group label:
Feedback Program
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
15 Years
Maximum age:
24 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cincinnati Children's Hospital Medical Center
Address:
City:
Cincinnati
Zip:
45229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Meghan E McGrady, PhD
Phone:
513-803-8044
Email:
Meghan.McGrady@cchmc.org
Facility:
Name:
St Jude Children's Research Hospital
Address:
City:
Memphis
Zip:
38105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rachel Tillery Webster, PhD
Email:
Rachel.Webster@STJUDE.ORG
Facility:
Name:
Seattle Children's Hospital
Address:
City:
Seattle
Zip:
98105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tyler Ketterl, MD
Email:
Tyler.Ketterl@seattlechildrens.org
Start date:
February 23, 2023
Completion date:
November 30, 2024
Lead sponsor:
Agency:
Children's Hospital Medical Center, Cincinnati
Agency class:
Other
Collaborator:
Agency:
St. Jude Children's Research Hospital
Agency class:
Other
Collaborator:
Agency:
Seattle Children's Hospital
Agency class:
Other
Collaborator:
Agency:
University of Cincinnati
Agency class:
Other
Source:
Children's Hospital Medical Center, Cincinnati
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05706610
