Medication AdherenceNCT07562399
Adjuvant Endocrine Therapy Adherence Intervention Pilot in Rwanda
A study testing Educational video, Symptom monitoring card and Text reminders in people with Medication Adherence and Breast Cancer, run by Dana-Farber Cancer Institute at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Medication Adherence, Breast Cancer
- What is being tested?
- Educational video, Symptom monitoring card and Text reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 20 Sep 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States3 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02053
Temidayo Fadelu, MD, 617-632-3779, temidayo_fadelu@dfci.harvard.edu
Temidayo Fadelu, MD
Boston Children's Hospital
Boston, Massachusetts, 02115
Temidayo Fadelu, MD, 617-632-3779, temidayo_fadelu@dfci.harvard.edu
Temidayo Fadelu, MD
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Temidayo Fadelu, MD, 617-632-3779, temidayo_fadelu@dfci.harvard.edu
Temidayo Fadelu, MD
Rwanda1 site
Butaro Cancer Center of Excellence
Butaro, RN8, 02053
Temidayo Fadelu, MD, 2406608885, temidayo_fadelu@dfci.harvard.edu
Temidayo Fadelu, MD
About this study
Official title: Piloting an Intervention to Improve Adjuvant Endocrine Therapy Adherence in Patients With Breast Cancer 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.
Read the 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.
- Conditions
- Medication Adherence, Breast Cancer
- Being tested
- Educational video, Symptom monitoring card, Text reminders
- Keywords
- breast cancer, medication adherence, ER-positive breast cancer
- Medical subject headings
- Medication Adherence, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoBehavioural
One-time educational video
Symptom monitoring cardBehavioural
Symptom monitoring card
Text remindersBehavioural
Weekly one-way text reminders
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Educational video; Behavioral: Symptom monitoring card; Behavioral: Text reminders |
| Control | No intervention | Participants will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: At 3- and 6-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start20 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Temidayo Fadelu, MD, Dana-Farber Cancer Institute
- Investigators
- Temidayo Fadelu, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562399
- Sponsor's protocol ID
- 25-838
- Other IDs
- 108707
- Status last verified
- May 2026
- First submitted
- 27 Apr 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting an Intervention to Improve Adjuvant Endocrine Therapy Adherence in Patients With Breast Cancer in Rwanda
- ClinicalTrials.gov ID
- NCT07562399
- Acronym / sponsor ID
- 25-838
- Conditions
- Medication Adherence, Breast Cancer
- Keywords
- breast cancer, medication adherence, ER-positive breast cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Educational video, Behavioral: Symptom monitoring card, Behavioral: Text remindersParticipants 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 intervention | –Participants will receive standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational videoOne-time educational video | Behavioural | Intervention |
| Symptom monitoring cardSymptom monitoring card | Behavioural | Intervention |
| Text remindersWeekly one-way text reminders | Behavioural | Intervention |
Primary outcome
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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Temidayo Fadelu, MD principal investigator
Dana-Farber Cancer Institute
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video, Symptom monitoring card and Text reminders in people with Medication Adherence and Breast Cancer, run by Dana-Farber Cancer Institute at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Temidayo Fadelu, MD (617-632-3779, temidayo_fadelu@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-month Adherence Rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.