Intervention for Medication Adherence in Cancer

Overseen By Claudia Dourado

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Must be taking: Oral chemotherapeutics

Disqualifiers: Dementia, Non-compliance, Pregnant, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how well patients adhere to their oral cancer medication routines, focusing on those with low literacy and limited economic resources. Participants in the intervention group will receive additional support, such as educational videos and follow-up phone calls, to better manage their treatment. The trial includes individuals diagnosed with certain types of advanced cancers, like stage IV breast or lung cancer, who are taking oral chemotherapy. This trial may suit those facing challenges in managing their medication due to literacy or financial issues. As an unphased trial, it offers a unique opportunity for patients to receive extra support in managing their treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It focuses on patients already taking oral anti-cancer medications, so you may be able to continue your current treatment.

What prior data suggests that this intervention is safe?

In a previous study, participants who watched educational videos about living with oral cancer treatment reported no serious safety issues. These videos use simple language suitable for a 4th-grade reading level, ensuring accessibility even for those with reading difficulties. Although detailed safety data for this specific program is unavailable, educational videos and phone follow-ups are generally considered low-risk. Similar educational programs have reported no negative effects, suggesting that the program is likely safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to improve medication adherence in cancer patients. Unlike standard treatments that focus solely on the medical aspect, this approach includes educational videos and easy-to-understand materials to help patients better manage their oral cancer treatment. Additionally, the trial involves personalized follow-up calls, ensuring that patients receive support and guidance, which could lead to better health outcomes. By targeting the barriers to medication adherence, this innovative strategy aims to help patients stick to their treatment plans more effectively.

What evidence suggests that this digital meditation intervention is effective for improving medication adherence in cancer patients?

This trial will compare a standard care group with an intervention group to improve medication adherence in cancer patients. Research has shown that educating patients about their cancer treatment can help them take their medications correctly. Participants in the intervention group will receive simple videos and materials written at a fourth-grade reading level, making it easier to understand their treatment and follow medication schedules. Studies have found that when patients receive clear, easy-to-understand information and regular check-ins, they are more likely to take their medications as directed. This method benefits those who may have trouble reading or face financial challenges. Regular follow-ups, such as quick phone calls, also help remind and support patients in adhering to their medication plan. ^{1 3 6 7 8}

Who Is on the Research Team?

Claudia M Dourado, MD

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

This trial is for patients with various advanced cancers (stage III/IV breast, colorectal, non-small cell lung cancer, renal cell carcinoma, ovarian carcinoma; multiple myeloma; chronic myelogenous leukemia on TKI therapy; myelodysplastic syndrome on Lenalidomide; adjuvant treatment for Gastro Intestinal Stromal Tumor or chronic Lymphocytic Leukemia) who are taking oral chemotherapy and have low literacy and socio-economic status.

Inclusion Criteria

I have been diagnosed with liver cancer.

My condition is stage IV Melanoma.

I have been diagnosed with myelofibrosis or a related blood disorder.

Exclusion Criteria

Non-English speaker

Pregnant patients

History of non-compliance (defined as the history of 2 or more missed appointments in the clinic)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard care or enhanced intervention to improve adherence to oral chemotherapy

6 months

Regular visits to the oncology clinic, with additional phone calls

Follow-up

Participants are monitored for adherence to oral chemotherapy and healthcare utilization

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Intervention

Trial Overview The study at Einstein Medical Center aims to understand how well patients from diverse backgrounds with low literacy and poor socio-economic status adhere to their prescribed oral anti-cancer medications.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

In addition to the standard of care, the participants randomized to Intervention Group will be invited to a separate room. The following activities will be undertaken, in order to address patients' questions and concerns, and discuss potential solutions to their barriers to care The patient will be asked to watch brief educational videos on "Life with oral cancer treatment." The information contained in the videos will be reinforced with materials written at a 4th grade level, that correspond to each of the brief videos.The patient will receive a brief phone call (from the study coordinator) on the first business day following the baseline interview, and thereafter, two weeks following each visit to the oncology clinic.

Group II: Standard of Care (Control Group) Active Control 1 Intervention

All participants in this group will receive the standard of care intervention provided by the RN.

Intervention is already approved in United States for the following indications:

Approved in United States as Digital Meditation Intervention for:

• Loneliness in Older Adults
• Social Isolation
• Emotional Well-being

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Albert Einstein Healthcare Network

Lead Sponsor

Trials

65

Recruited

869,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11234071/

Effectiveness of Web-Based Mindfulness ... App- and website-based MBIs show promise for improving mental health and QOL outcomes in patients with cancer, and further research is needed.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6302233/

Adherence to a Mindfulness and Relaxation Self-Care App ... Our study indicates that a mindfulness and relaxation mHealth intervention for cancer patients is feasible with acceptable adherence and largely positive ...

3. academic.oup.com academic.oup.com/oncolo/article/30/1/oyae309/7959402

Feasibility and acceptability of a mindfulness app-based ... Among 50 patients with mRCC, the feasibility of this intervention was demonstrated; 96% of patients were assessed at week 4, with high adherence ...

4. nature.com nature.com/articles/s41746-025-01688-x

Mobile health intervention CanRelax reduces distress in ... The CanRelax 2 app was effective in reducing distress in people with cancer after 10 weeks with a moderate treatment effect that is clinically ...

5. cancer.jmir.org cancer.jmir.org/2024/1/e52386

Engagement With a Relaxation and Mindfulness Mobile App ... The intervention was a fully automated mHealth app designed specifically to improve distress in adults with cancer through one type of self-care ...

6. researchprotocols.org researchprotocols.org/2020/5/e15178/

A Smartphone App–Based Mindfulness Intervention for ... Participant engagement in a commercially available app-based mindfulness training intervention delivered to women diagnosed with breast cancer.

7. cancer.jmir.org cancer.jmir.org/2025/1/e54154

Benefits of Remote-Based Mindfulness on Physical Symptom ... After remote-based mindfulness treatment, cancer survivors showed a significant reduction in fatigue (SMD −0.94; 95% CI: −1.56 to −0.33; P=.002) ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03528863

Web-based Mindfulness Meditation in Reducing Distress in ... This trial studies how well web-based mindfulness meditation works in reducing distress in both participants with gastrointestinal cancer that has spread to ...