A Pilot Trial of a Community-Based Strategy to Improve Colorectal and Breast Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 7
- 主要终点
- Intervention Acceptability Score
研究概览
简要总结
The goal of the proposed study is to conduct a pilot randomized controlled trial (RCT) of Chi gung, a community-based intervention using peer education and tailored navigation to simultaneously improve colorectal (CRC) and breast cancer (BC) screening rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 45-75 years old
- •Self-identify as Chinese and born outside of the U.S.
- •Speaks Mandarin, Cantonese, or English
- •Not up to date on BC screening (i.e., have not had a mammogram within the past two years)
- •Not up to date on CRC screening (i.e., have not had any of the following tests)
- •Colonoscopy within the past 10 years
- •Fecal immunochemical tests/fecal occult blood tests within the past year or multi-target stool DNA test within the past three years
- •Flexible sigmoidoscopy within the past 5 years
- •CT colonography within the past 5 years
排除标准
- •Life expectancy ≤ 10 years or other pre-existing conditions whereby CRC or BC screening would not be recommended
- •Personal history of BC or CRC
- •Prior history of a total colectomy or mastectomy
- •Lacks capacity to provide informed consent
研究组 & 干预措施
Chi gung: Stay Well, Live Well
Chi gung: Stay Well, Live Well is a community-based intervention using peer education and tailored navigation
干预措施: Chi gung: Stay Well, Live Well (Behavioral)
Attention Control (AC) Arm
This time-matched and attention control group will receive a general health group education session and follow-up telephone calls.
干预措施: Chi gung: Stay Well, Live Well (Behavioral)
结局指标
主要结局
Intervention Acceptability Score
时间窗: 6 Months
This will measure whether the participants will accept the intervention. Acceptability will be measured through surveys (likert-rated items) and open-ended questions (semi-structured interviews). The minimum score is 6 and the maximum score is 42; higher scores indicate the intervention is acceptable.
Number of Navigation Calls
时间窗: 6 Months
This will measure how well the participants can be navigated through the healthcare system and connected to resources using this intervention. Integration will be measured through review of navigation call logs and will include number of navigation calls completed per participant, number of self-reported healthcare visits by the participant, and open-ended questions (semi-structured interviews).
Intervention Adaptation Score
时间窗: Baseline, Immediately Post-Education Session, 6 Months
This will measure how well the intervention was adapted to address colorectal cancer (CRC) and breast cancer (BC) screening beliefs, benefits, barriers, and self-efficacy. Adaptation will be measured through surveys (likert-rated) and open-ended questions (semi-structured interviews). These measures are investigator-developed subscales informed by the literature. On the beliefs subscale, the minimum score is 17 and the maximum score is 85; higher scores indicate more favorable screening beliefs. On the benefits subscale, the minimum score is 3 and the maximum score is 15; on the barriers subscale, the minimum score is 5 and the maximum score is 25. Higher scores indicate greater perceived benefits and greater perceived barriers, respectively. On the self-efficacy subscale, the minimum score is 8 and the maximum score is 40; higher scores indicate greater self-efficacy to complete screening.
The Proportion of Participants Who Have Completed Recommended Screening Tests.
时间窗: 6 Months
The proportion of participants who have completed recommended CRC and BC screening tests to assess intervention efficacy.
次要结局
未报告次要终点
研究者
Christina Wang
Assistant Professor of Medicine
Icahn School of Medicine at Mount Sinai