Tailored Program for Cancer

Not yet recruiting at 3 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 anticancer agents

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 whether a personalized program can help young people with cancer adhere to their medication routine and improve their quality of life. Researchers aim to determine if this tailored approach, called the Tailored Medication Adherence-Promotion Intervention, results in better medication adherence, a more positive quality of life, and fewer healthcare visits. Participants will use electronic pill bottles, meet with a coach, and receive text check-ins over an 8-week period. The study seeks 15 to 24-year-olds with cancer who are taking oral cancer medications and have had difficulty maintaining their medication routine. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance support for young cancer patients.

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

The trial information does not specify if you need to stop taking your current medications. It seems focused on helping you take your prescribed cancer medications more effectively.

What prior data suggests that this tailored intervention is safe for adolescents and young adults with cancer?

Research has shown that the program designed to help people take their medication has undergone previous testing. These studies assessed the program's feasibility and user-friendliness. Reports indicate that participants generally found the program acceptable, feeling comfortable with its organization and operation.

While specific safety details aren't highlighted, the program focuses on improving medication habits through coaching and text reminders. It does not involve new drugs or treatments, which typically means fewer health risks. Participants in earlier trials did not report any serious side effects from participating in the program.

Overall, this program appears to be well-tolerated. As a support program rather than a medication, it is unlikely to have the side effects associated with drugs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tailored Medication Adherence-Promotion Intervention because it offers a more personalized approach to supporting cancer patients in sticking to their treatment plans. Unlike the standard care options, which typically provide uniform feedback through weekly texts, this tailored program includes personalized coaching sessions and text check-ins over an eight-week period. This approach aims to address the unique challenges and barriers each patient faces, potentially leading to better treatment adherence and improved outcomes. By focusing on individualized support, the program could significantly enhance the effectiveness of cancer treatments.

What evidence suggests that this tailored intervention is effective for improving medication adherence in adolescents and young adults with cancer?

Studies have shown that many teenagers and young adults with cancer struggle to take their medication as prescribed, with up to 60% regularly missing doses. Research suggests that a personalized approach can improve adherence. In this trial, participants in the Tailored Program arm will receive support through visits from a coach and text message reminders. Previous findings indicate that these methods may help patients take their medication more consistently. This personalized approach aims to simplify following the treatment plan and improve quality of life by reducing the stress of managing medication. Early evidence shows promise in helping young cancer patients manage their treatment more effectively. ^{1 2 4 6 7}

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 with cancer who are having trouble taking their medications regularly. Participants will use an electronic pill bottle or box and attend intervention sessions.

Inclusion Criteria

I am taking oral medication for cancer.

I am between 15 and 24 years old.

I have been diagnosed with cancer.

Exclusion Criteria

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

Patient evidences significant cognitive deficits

Patient's medical status or treatment precludes participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Monitoring

Participants use an electronic pill bottle or box to assess baseline adherence

A few weeks

Treatment

Participants undergo an 8-week program with either the Tailored Program or Feedback Program

8 weeks

4 coach visits and 4 text check-ins for Tailored Program; weekly texts for Feedback Program

Post-Treatment Monitoring

Participants continue to use the electronic monitor for medication adherence for 1 month post-treatment

1 month

Follow-up

Participants complete questionnaires and are monitored for quality of life and healthcare utilization

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Tailored Medication Adherence-Promotion Intervention

Trial Overview The study tests if a tailored program helps these patients stick to their medication schedule better than the usual care does. It also looks at whether this improves quality of life and reduces hospital visits.

How Is the Trial Designed?

Group I: Tailored Program Experimental Treatment 1 Intervention

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

Group II: Feedback Program (Uniform Standard of Care) Experimental Treatment 1 Intervention

8-week feedback program including weekly texts

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

University of Kansas Medical Center

Collaborator

Trials

527

Recruited

181,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07223463

A Tailored Medication Adherence-Promotion Intervention ... The proposed research includes a randomized clinical trial of a tailored adherence-promotion intervention (Tailored Program) as compared to uniform standard of ...

2. 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.

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

Feasibility pilot trial of a tailored medication adherence ... Feasibility pilot trial of a tailored medication adherence-promotion intervention for adolescents and young adults with cancer: Study design and protocol.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/pdf/10.1002/pbc.32127

Feasibility Trial of a Tailored Adherence‐Promotion ... Up to 60% of AYAs with cancer demonstrate non-adherence, with AYAs missing an average of 19%–25% of medication doses. [5]. Non-adherence ...

5. reporter.nih.gov reporter.nih.gov/search/P9tRcMqsR0OdeahBARVo2g/project-details/11194618

Project Details The proposed research will evaluate the efficacy of a tailored adherence-promotion intervention for adolescents and young adults with cancer. Findings from this ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/pbc.32127

Feasibility Trial of a Tailored Adherence‐Promotion ... This randomized pilot trial evaluated the feasibility, usability, and acceptability of a tailored adherence-promotion intervention (Supporting ...

7. ovid.com ovid.com/journals/pedbc/pdf/10.1002/pbc.32127~feasibility-trial-of-a-tailored-adherence-promotion

Feasibility Trial of a Tailored Adherence-Promotion ... Up to 60% of AYAs with cancer demonstrate non-adherence, with AYAs missing an average of 19%–25% of medication doses. [5]. Non-adherence ...