INTENT Pilot Study - Enhancing Adherence Intentions to Endocrine Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Engagement Rate of Intervention
研究概览
简要总结
This research is being done to pilot an intervention which aims to improve participants' experiences on Endocrine Therapy.
The name of the intervention used in this research study is:
Endocrine Therapy Education Program (a brief, video-based intervention)
详细描述
This research study is a randomized pilot study to determine whether a brief-video based intervention program can improve experiences of Endocrine Therapy (ET). Participants will be randomized into one of two groups: Group A: Endocrine Therapy Education Intervention vs. Group B Wait-list Control Group. Randomization means a participant is placed into a study group by chance.
The research study procedures include screening for eligibility, in-clinic visits, and survey questionnaires.
Participation in this research study is expected to last 3 months.
It is expected that about 60 people will take part in this research study.
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
- •Biologically female
- •About to begin or just started (within four weeks of starting) an oral form of ET (either tamoxifen or AI)
- •18 years of age or older
- •English fluency for reading and writing.
- •Computer literacy (ability to watch videos and fill out questionnaires online)
排除标准
- •Adults unable to consent
- •Individuals with metastatic cancer
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
结局指标
主要结局
Engagement Rate of Intervention
时间窗: 6 weeks
Adequate engagement of the intervention is defined as a click-to-open rate of 60% or over for the intervention group.
Intervention Satisfaction Questionnaire Mean Score Group A
时间窗: At 6 weeks
Responses will be analyzed to determine a mean score for each item for the intervention group. The Intervention Satisfaction Questionnaire includes 9 items rated on a 1 to 10 scale.
Intervention Satisfaction Questionnaire Mean Score Group B
时间窗: At 14 weeks
Responses will be analyzed to determine a mean score for each item for the control group (following the release of the intervention educational videos). The Intervention Satisfaction Questionnaire includes 9 items rated on a 1 to 10 scale.
次要结局
未报告次要终点
研究者
Ann H. Partridge, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute