A Mobile TXT-Based Intervention to Improve Adherence to Adjuvant Hormone Therapy and Symptom Management for BCa Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 332
- 试验地点
- 14
- 主要终点
- Adjuvant hormone therapy (AHT) adherence
研究概览
简要总结
This trial studies how well a text-based intervention works in improving adherence to hormone therapy in patients with stage I-III hormone receptor positive breast cancer. Women often require long term therapy with adjuvant hormone therapy to prevent the cancer from returning and to improve overall survival. Side effects from hormone therapy may prevent some women from staying adherent to their medication therapy. A text-based intervention may provide educational information to breast cancer patients who are undergoing adjuvant hormone therapy.
详细描述
PRIMARY OBJECTIVES:
I. Examine the efficacy of messaging for adjuvant hormone therapy compliance promotion (mAHT-CaP) in a randomized control trial (RCT) design.
SECONDARY OBJECTIVES:
I. Conduct mediator analyses of intervention efficacy..
EXPLORATORY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Woman diagnosed with stage I-III breast cancer (BCa).
- •Hormone receptor positive tumor.
- •Completed local definitive treatment (i.e., surgery chemotherapy, radiation).
- •Within 3 month of initiation of a new adjuvant hormonal therapy (AHT) regimen.
- •At least 12 months of AHT recommended.
- •Able to read and understand English.
- •Able to provide informed consent.
- •Have a mobile device with text (TXT) capability.
- •Know or willing to learn how to use TXT.
排除标准
- •Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex).
结局指标
主要结局
Adjuvant hormone therapy (AHT) adherence
时间窗: Up to 12 months
Assessed by wireless smart pill bottles for all participants. Daily adherence will be defined as accessing the pill bottle once per 24 hour period. Proportion adherence will be summarized by week and study arm, and presented graphically.
Symptom distress
时间窗: Up to 12 months
Measured by the Breast Cancer Prevention Trial Symptom Scale, which has sound psychometric properties in breast cancer (BCa) patients. There are a total of 43 items in the scale across eight domains. Each item is a five-point Likert scale, ranging from 0 (not at all) to 4 (extremely), used to rate symptoms. Items accounting for side effects specifically related to AHT (e.g., bone pain) and other general symptoms (e.g., constipation) are added. Participants are asked whether they are bothered by each symptom and whether they think it related to their AHT or not. The two resulting scales consist of the sum of the endorsed symptom total each woman does or does not attribute to AHT.
次要结局
- Cognitive-affective barriers for AHT adherence(Up to 12 months)
- Cognitive-affective barriers for symptom distress(Up to 12 months)
研究者
Kuang-Yi Wen
Associate Professor - Medical Oncology
Thomas Jefferson University