Tailored Adherence Program for Young Adults with Cancer

No longer recruiting at 2 trial locations

Overseen By Meghan E McGrady, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Must be taking: Oral chemotherapy

Disqualifiers: Non-English, Cognitive deficits, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a personalized support program can help young adults with cancer adhere to their treatment plans. Participants will join either a tailored program with coach visits and texts or a feedback program with weekly texts. Researchers aim to determine if these methods are user-friendly and beneficial for participants. Young adults aged 15 to 24 taking oral chemotherapy or preventive medication may be suitable for this study. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative support strategies that could enhance adherence to cancer treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on adherence to prescribed oral chemotherapy or prophylactic medication, so you may be able to continue your current meds, but it's best to confirm with the trial coordinators.

What prior data suggests that these programs are safe for young adults with cancer?

Research shows that the tailored program is generally safe and well-received by young adults with cancer. In past studies, participants found the program easy to use and satisfactory, valuing the materials provided. This indicates that the program not only helps individuals adhere to their treatment but is also user-friendly.

Specific information about the feedback program is limited, but it aims to address emotional and social needs, enhancing the overall well-being of young adults with cancer. Both programs focus on providing support and assisting individuals in following their treatment plans, which are crucial for successful outcomes. Overall, both treatments appear safe and have been positively received for improving medication adherence and support among young adults with cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on personalized support programs designed to help young adults with cancer stick to their treatment plans. Unlike traditional approaches that might rely solely on medication or standard care protocols, the Tailored Program offers a unique combination of personalized coaching and regular text check-ins over an 8-week period. This approach aims to engage participants more deeply and tailor support to their individual needs, potentially improving adherence and overall outcomes. Additionally, the Feedback Program provides consistent weekly text feedback, which could help maintain motivation and track progress. These innovative strategies hope to address the unique challenges faced by younger cancer patients in maintaining their treatment regimens.

What evidence suggests that this trial's programs could be effective for young adults with cancer?

This trial compares two programs designed to help young adults with cancer adhere to their medication schedules. The Tailored Program, one study arm, includes an 8-week tailored program with 4 coach visits and 4 bi-weekly text check-ins. Research has shown that personalized programs like this can be effective and well-received by adolescents and young adults (AYAs). The Feedback Program, another arm in this trial, consists of an 8-week feedback program with 8 weekly texts. Although specific data on the feedback program is limited, personalized approaches generally help improve medication adherence, which is crucial for better health outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Meghan E McGrady, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults aged 15-24 with cancer who are prescribed oral chemotherapy or prophylactic medication. They must be fluent in English without significant cognitive deficits, as judged by their medical team, and willing to use an electronic monitoring device. Those already showing high adherence (95% or more) during a preliminary period won't qualify.

Inclusion Criteria

I am taking oral chemotherapy or medication to prevent illness.

I have been diagnosed with cancer.

I am between 15 and 24 years old.

Exclusion Criteria

I am not fluent in English.

Patient evidences significant cognitive deficits per medical team

Patient demonstrates greater than or equal to 95% adherence during run-in period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Adherence Monitoring

Participants use the eCAP electronic monitor for 4 weeks to assess baseline adherence

4 weeks

No in-person visits, electronic monitoring

Treatment

Participants are randomized to either the Tailored Program or Feedback Program for adherence promotion

8 weeks

4 coach visits (in-person or virtual) and 4 text check-ins for Tailored Program; 8 weekly texts for Feedback Program

Follow-up

Participants continue using the electronic monitor and complete post-treatment questionnaires regarding program usability and acceptability

4 weeks

No in-person visits, electronic monitoring and questionnaires

What Are the Treatments Tested in This Trial?

Interventions

• Feedback Program
• Tailored Program

Trial Overview The study tests a tailored program against the standard uniform care to improve medication adherence in young cancer patients. It's designed to see if the new approach is feasible, easy to use, acceptable, and meets certain criteria regarding enrollment, retention, fidelity of implementation, and data completion.

How Is the Trial Designed?

Group I: Tailored Program Experimental Treatment 1 Intervention

8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins

Group II: Feedback Program Experimental Treatment 1 Intervention

8-week feedback program including 8 weekly texts

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

St. Jude Children's Research Hospital

Collaborator

Trials

451

Recruited

5,326,000+

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424000570

Feasibility pilot trial of a tailored medication adherence ... Medication non-adherence is common among adolescents and young adults (AYAs) with cancer and associated with poor health outcomes. AYAs with cancer endorse ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11988022/

A Pilot Study to Evaluate the Feasibility and Acceptability of a ... A pilot study to evaluate the feasibility and acceptability of a tailored multicomponent rehabilitation program for adolescent and young adult (AYA) cancer ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pbc.32127

Feasibility Trial of a Tailored Adherence‐Promotion ... Data from this pilot trial suggest that this tailored adherence-promotion intervention is feasible, usable, and acceptable among AYAs with ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07223463

A Tailored Medication Adherence-Promotion Intervention ... The goal of this clinical trial is to learn if a tailored intervention can help make it easier for adolescents and young adults with cancer to take their ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10960689/

Feasibility Pilot Trial of a Tailored Medication Adherence ... A tailored medication adherence-promotion intervention for adolescents and young adults with cancer: study design and protocol.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11120301/

Need for Behavioral Interventions for Young Adults Living ... This commentary identifies unmet psychosocial needs and offers recommendations for targeted interventions to help improve overall quality of care.

7. healthcaredelivery.cancer.gov healthcaredelivery.cancer.gov/aya/

Adolescent & Young Adult Health Outcomes & Patient ... The adolescent and young adult (AYA) population between the ages of 15 and 39 years has seen little or no improvement in cancer survival rates for decades.

8. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12547-5

Peer2Me – evaluation of a peer supported program for ... Peer2Me is a 1:1 mentoring program that aims to support acutely ill young adults with cancer with the help of a mentor in their immediate coping ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0305737225001148

Long-term surveillance recommendations for young adult ... This scoping review aims to summarize existing recommendations for long-term surveillance of YACS, identify gaps in current guidelines, and highlight areas for ...

10. mdpi.com mdpi.com/2072-6694/17/3/454

Core Patient-Centered Outcomes for Adolescents and ... Core patient-centered outcomes for adolescents and young adults with cancer: a comprehensive review of the literature from the STRONG-AYA Project.