Piloting an Intervention to Improve Adjuvant Endocrine Therapy Adherence in Patients With Breast Cancer in Rwanda
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 224
- 试验地点
- 4
- 主要终点
- 3-month Adherence Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Control
Participants will receive standard care.
Intervention
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.
干预措施: Symptom monitoring card (Behavioral)
Intervention
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.
干预措施: Educational video (Behavioral)
Intervention
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.
干预措施: Text reminders (Behavioral)
结局指标
主要结局
3-month Adherence Rate
时间窗: 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.
次要结局
- 6-month persistence, 3 and 6 month QOL on FACT(At 3- and 6-months)
- Functional Assessment of Cancer Therapy-Breast (FACT-B) Score at 3- and 6-months(At 3- and 6-months.)
研究者
Temidayo Fadelu, MD
Principal Investigator
Dana-Farber Cancer Institute