Adjuvant Endocrine Therapy Adherence Intervention Pilot in Rwanda
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Educational video, Symptom monitoring card, Text reminders.
- Who it may be relevant to
- Registry conditions: Medication Adherence, Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Rwanda
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Piloting an Intervention to Improve Adjuvant Endocrine Therapy Adherence in Patients With Breast Cancer in Rwanda
Overview
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.
Interventions
- Behavioral Educational video
One-time educational video - Behavioral Symptom monitoring card
Symptom monitoring card - Behavioral Text reminders
Weekly one-way text reminders
Primary outcome measures
- 3-month Adherence Rate [Time frame: 3 months]
Secondary outcome measures (2)
- 6-month persistence, 3 and 6 month QOL on FACT [Time frame: At 3- and 6-months]
- Functional Assessment of Cancer Therapy-Breast (FACT-B) Score at 3- and 6-months [Time frame: At 3- and 6-months.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 3 centers
- Brigham and Women's Hospital — Boston
- Boston Children's Hospital — Boston
- Dana-Farber Cancer Institute — Boston
Rwanda · 1 center
- Butaro Cancer Center of Excellence — Butaro
Identifiers
NCT: NCT07562399 · 25-838 · 108707