An interventional study of Educational video and Symptom monitoring card in Medication Adherence and Breast Cancer, sponsored by Dana-Farber Cancer Institute. Not yet recruiting at 4 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Health services research
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.
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.
937 studies on the registry are indexed under Medication Adherence; 159 are open to participants now.
This study's planned enrollment of 224 is above the median of 120 across 768 interventional studies indexed under Medication Adherence.
Browse Medication Adherence studies →Dana-Farber Cancer Institute is the lead sponsor of 834 studies on the registry; 122 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 78 (68%) have results posted.
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Exclusion Criteria:
Participants 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.
Behavioral: Educational video · Behavioral: Symptom monitoring card · Behavioral: Text reminders
Participants will receive standard care.
One-time educational video
Symptom monitoring card
Weekly one-way text reminders
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.
Time frame: 3 months
6-month persistence, 3 and 6 month QOL on FACT
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.
Time frame: At 3- and 6-months
Functional Assessment of Cancer Therapy-Breast (FACT-B) Score 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.
Time frame: At 3- and 6-months.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
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
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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