Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 108707 | Other Grant/Funding Number | Harold Amos Medical Faculty Development Program (AMFDP) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | Participants will receive standard care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational video | Behavioral | One-time educational video |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 3- and 6-months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Temidayo Fadelu, MD | Contact | 617-632-3779 | temidayo_fadelu@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Temidayo Fadelu, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02053 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu
Not provided
Not provided
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Symptom monitoring card |
| Behavioral |
Symptom monitoring card |
|
| Text reminders | Behavioral | Weekly one-way text reminders |
|
| 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. | At 3- and 6-months. |
| 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 |
|
| D001519 | Behavior |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |