Adjuvant Endocrine Therapy Adherence Pilot in Rwanda

This study is testing a new way to help women with ER-positive breast cancer (a type of breast cancer that grows in response to hormones) remember to take their adjuvant endocrine therapy (AET). AET is a medication taken after initial cancer treatment to help prevent the cancer from coming back. The study will test an intervention that includes an educational video, a symptom monitoring card, and weekly text message reminders. We want to see if these tools help women take their medication as prescribed. You may be able to join if you are a woman aged 18 or older with ER-positive breast cancer, have been on AET for 6 to 36 months, and have a cellphone. The main goal is to see how well participants stick to their medication schedule after 3 months. The current recruitment status is unclear.

Study design
This is a randomized study, meaning participants will be assigned by chance to either receive the new support package or standard care. About 224 women are expected to participate.
What's involved
If you join, you will be screened for eligibility, complete questionnaires, and may receive an educational video, a symptom monitoring card, and weekly text message reminders. Your participation is expected to last about 6 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 3 months, indicating follow-up for at least that duration.

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NCT07562399

Adjuvant Endocrine Therapy Adherence Intervention Pilot in Rwanda

Not Yet Recruiting
NAAges 18+InterventionalHealth services
Dana-Farber Cancer Institute
~224 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:Educational videoSymptom monitoring cardText reminders

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
3-month Adherence Rate
Measured over 3 months
Medication Adherence
Breast Cancer
4 sites across 2 states
Massachusetts3
RN81
  • Temidayo Fadelu, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

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Eligibility criteria

Inclusion

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

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
  • 3-month Adherence Rate3 months

    The proportion of participants adhering to adjuvant endocrine therapy (AET) is based on the Simplified Medication Adherence Questionnaire (SMAQ; Knobel et al. J Acq Immune Deficiency Syndromes 2002). SMAQ is a 6-item assesment tool but only the 4 yes/no questions are used for this endpoint. An affirmative answer to any of the 4 questions defines non-adherent status.