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NCT Number: NCT07562399

Adjuvant Endocrine Therapy Adherence Intervention Pilot in Rwanda

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.

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Key information

Conditions

Medication Adherence Behavior Breast Cancer Breast Diseases Breast Neoplasms Health Behavior Neoplasms Neoplasms by Site Patient Acceptance of Health Care Patient Compliance Skin Diseases Skin and Connective Tissue Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Butaro Cancer Center of Excellence, Butaro, RN8, Rwanda

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Video

Behavioral

One-time educational video

Symptom monitoring card

Behavioral

Symptom monitoring card

Text reminders

Behavioral

Weekly one-way text reminders

Primary outcomes

  1. 3-month Adherence Rate

    Time frame: 3 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.

Secondary outcomes

  1. 6-month persistence, 3 and 6 month QOL on FACT

    Time frame: At 3- and 6-months

    FACT-ES has 46-items including the 27-item FACT-General (FACT-G) and a 19-item endocrine subscale. (Fallowfield et al. Breast Cancer Research and Treatment 1999) It is scored on a likert scale (0=not at all to 4=very much) with higher scores (range 0-184) indicating better quality of life and fewer symptoms.

  2. Functional Assessment of Cancer Therapy-Breast (FACT-B) Score at 3- and 6-months

    Time frame: At 3- and 6-months.

    FACT-B has 37-items including the 27-item FACT-General (FACT-G) and a 10-item breast cancer subscale. (Brady et al. JCO 1997) It is scored on a likert scale (0=not at all to 4=very much) with higher scores (range 0-148) indicating better quality of life and fewer symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Temidayo Fadelu, MD

CONTACT

[email protected]

617-632-3779

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 1, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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