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ClinicalTrials.gov ID

NCT07562399

Lead Sponsor

Dana-Farber Cancer InstituteOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

224Estimated

Last Update Posted

May 20, 2026Actual

Start Date

Sep 20, 2026Estimated

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2028Estimated

Official Title

Piloting an Intervention to Improve Adjuvant Endocrine Therapy Adherence in Patients With Breast Cancer in Rwanda

Brief Summary

This study aims to evaluate a multi-modal intervention designed to improve adherence to adjuvant endocrine therapy (AET) among patients with ER-positive breast cancer in Rwanda. The intervention includes educational, behavioral, and reminder components, and will be assessed for feasibility and impact on medication adherence.

Detailed Description

This is a randomized study evaluating a light-touch, multi-modal medication adherence support package designed to improve adherence to adjuvant endocrine therapy in adults with confirmed ER-positive breast cancer undergoing curative intent treatment. Eligible participants will be within 6-36 months of adjuvant endocrine therapy initiation and will be randomized to receive either standard care or the medication adherence support package, which includes a one-time educational video, a symptom monitoring card, and weekly one-way text message reminders.

The research study procedures include: screening for eligibility, questionnaires/surveys, interviews, educational video, symptom monitoring card, and weekly text message reminders (as applicable). No additional in-person or telephone contact with research staff is planned beyond delivery of these materials.

It is expected that about 224 adults will take part in this study across all sites.

Participation in this research study is expected to last about 6 months.

• Medication Adherence
• Breast Cancer

• Educational video
• Symptom monitoring card
• Text reminders

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Female patients
• Age 18 or older
• Pathologic confirmation of ER-positive breast cancer
• Clinical or radiographic confirmation of disease localized to the breast and regional lymph nodes
• Within 6-36 months of starting AET
• Have a cellphone capable of receiving text messages.
• Are currently receiving AET at Butaro or satellite clinics.

Exclusion Criteria:

• Unwilling/Unable to participate
• Unable to comprehend study languages (English or Kinyarwanda)
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Prisoners
• Pregnant women

Primary Purpose

Health Services Research

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Dana-Farber Cancer InstituteOTHER

temidayo_fadelu@dfci.harvard.edu2406608885