Breast Cancer, Medication Adherence
Conditions
Keywords
breast cancer, medication adherence, ER-positive breast cancer
Brief 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 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
BEHAVIORALEducational video
One-time educational video
BEHAVIORALSymptom monitoring card
Symptom monitoring card
BEHAVIORALText reminders
Weekly one-way text reminders
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-month Adherence Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| 6-month persistence, 3 and 6 month QOL on FACT | 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. |
| Functional Assessment of Cancer Therapy-Breast (FACT-B) Score at 3- and 6-months | 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. |
Countries
Rwanda, United States
Contacts
CONTACTTemidayo Fadelu, MD
PRINCIPAL_INVESTIGATORTemidayo Fadelu, MD
Dana-Farber Cancer Institute
Outcome results
None listed