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?

Einstein Medical Center in Philadelphia serves a diverse group of the patient population. The majority of patients have a diverse cultural background, low literacy, and poor social-economic status. Medication adherence for chronic medical problems is in a range of 40-70%. Medication adherence among patients on oral anti-cancer therapy is not studied in detail. The main objective is to study medication adherence to oral anticancer agents in patients with low literacy and poor socio-economic status.

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