Clinical trial NCT05706610: A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer
Official title: A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Adherence, Medication
Keywords: cancer
adherence
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: St. Jude Children's Research Hospital
name: Seattle Children's Hospital
name: University of Cincinnati
First posted: 2023-01-31
Enrollment: 24
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Enrollment Rate
timeFrame: End of study enrollment period, approximately 12 months after enrollment initiation
Secondary outcomes:
measure: Retention Rate
timeFrame: End of data collection period, approximately 18 months after enrollment initiation
measure: Intervention Fidelity: Contact
timeFrame: End of data collection period, approximately 18 months after enrollment initiation
measure: Intervention Fidelity: Length
timeFrame: End of data collection period, approximately 18 months after enrollment initiation
measure: Intervention Fidelity: Duration
timeFrame: End of data collection period, approximately 18 months after enrollment initiation
measure: Intervention Fidelity: Content
timeFrame: End of data collection period, approximately 18 months after enrollment initiation
measure: Assessment Completion
timeFrame: End of data collection period, approximately 18 months after enrollment initiation
measure: System Usability Scale
timeFrame: 4 weeks following treatment completion
measure: Adjective Rating Scale
timeFrame: 4 weeks following treatment completion
measure: Acceptability & Adherence Scale
timeFrame: 4 weeks following treatment completion
measure: Medical Adherence Measure
timeFrame: 4 weeks following treatment completion
measure: Electronically Monitored Medication Adherence
timeFrame: Starting 4 weeks prior to treatment initiation and continuing until 4 weeks following treatment completion
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Memphis
country: United States
facility: St Jude Children's Research Hospital
state: Tennessee
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Meghan E McGrady, PhD
role: PRINCIPAL_INVESTIGATOR
References: