AET Pilot Intervention
Piloting an Intervention to Improve Adjuvant Endocrine Therapy Adherence in Patients With Breast Cancer in Rwanda
2 other identifiers
interventional
224
2 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2026
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2026
CompletedFirst Posted
Study publicly available on registry
May 1, 2026
CompletedStudy Start
First participant enrolled
September 20, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
Study Completion
Last participant's last visit for all outcomes
December 31, 2028
May 1, 2026
April 1, 2026
1.3 years
April 27, 2026
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-month Adherence Rate
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.
3 months
Secondary Outcomes (2)
6-month persistence, 3 and 6 month QOL on FACT
At 3- and 6-months
Functional Assessment of Cancer Therapy-Breast (FACT-B) Score at 3- and 6-months
At 3- and 6-months.
Study Arms (2)
Intervention
EXPERIMENTALParticipants randomized to the intervention arm will receive a light-touch, multi-modal medication adherence support package, including a one-time educational video, a symptom monitoring card, and weekly one-way text message reminders.
Control
NO INTERVENTIONParticipants will receive standard care.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Brigham and Women's Hospital
Boston, Massachusetts, 02053, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Butaro Cancer Center of Excellence
Butaro, RN8, 02053, Rwanda
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Temidayo Fadelu, MD
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 27, 2026
First Posted
May 1, 2026
Study Start (Estimated)
September 20, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu
The Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.