Development and Pilot Testing of a Novel Intervention to Reduce Cardiovascular Disease Risk Among Breast Cancer Survivors Living in Rural, Medically Underserved Communities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Satisfaction with Treatment and Interventionist as measured by the Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)
研究概览
简要总结
This study is testing a new program called WeCan-Rural, designed to help breast cancer survivors manage symptoms and build healthy habits like eating well, staying active, and managing their weight. These changes may help lower the risk of heart disease after cancer treatment.
The study will answer two main questions:
- Can study team successfully recruit and keep participants in the study, and will the participants find the program helpful and easy to follow?
- Will participants who join the program see better results in areas like weight, symptoms, diet, physical activity, and confidence in managing the participant's health compared to those who receive standard care?
Here's what participants will do:
- Visit the participant's clinic twice (about 12 weeks apart) to be weighed, have the blood pressure checked, give a blood sample, and complete a short walking test
- Fill out online surveys about the participant's health, diet, physical activity, symptoms, and confidence in managing the participant's health
- Be randomly assigned (like flipping a coin) to either receive the WeCan-Rural program or standard health information
- If assigned to the program, attend 12 weekly one-hour video sessions on Zoom with a trained therapist
详细描述
Breast cancer survivors often face long-term health challenges after treatment, including a higher risk of heart disease. This risk is especially high for women living in rural areas, where access to healthcare and healthy food may be limited, and opportunities for physical activity may be harder to find. Many survivors also deal with ongoing symptoms like pain, fatigue, and emotional distress, which can make it harder to eat well, stay active, and manage their weight.
This study will test a program called WeCan-Rural, designed to help breast cancer survivors improve their health and lower their risk of heart disease. The program teaches skills for healthy eating, physical activity, and managing symptoms that can get in the way of a healthy lifestyle. It includes 12 weekly sessions delivered remotely through Zoom, so participants can join from home. Each session lasts about an hour and covers topics like nutrition, exercise, and ways to cope with symptoms using strategies like relaxation and pacing.
Participants will receive tools to help them track their progress, including a wireless activity tracker, a scale, and a blood pressure monitor. They'll also get printed materials and access to online videos showing how to do recommended exercises. If needed, participants will be provided with a tablet and data plan to make sure they can join the sessions.
The study will include 40 breast cancer survivors who have completed treatment and are living in rural, medically underserved areas. Half will receive the WeCan-Rural program, and half will receive standard health information from the National Cancer Institute. Researchers will look at how easy it is to recruit and keep participants in the program, how satisfied participants are with it, and whether it helps improve the participant's weight, symptoms, diet, physical activity, and confidence in managing the participant's health. The study will also measure changes in heart health indicators like blood pressure, cholesterol, and blood sugar.
If the program is found to be helpful and well-received, it may be tested in a larger study in the future.
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
- •aged 18 years or older
- •female (biological sex)
- •diagnosis of stage I-III breast cancer
- •completed treatments with curative intent (with the exception of hormonal treatments) in the last 5 years
- •body mass index >30
- •healthy enough to participate in home-based physical activity
- •able to speak/read English
- •reports rating of ≥4 (i.e., moderate or more severe) out of 10 for one or more of the following symptoms at its worst in the last month (per the MD Anderson Symptom Inventory): pain, fatigue, sadness, and/or distress
排除标准
- •visual, hearing or cognitive impairment or severe mental illness interfering with participation
研究组 & 干预措施
WeCan-Rural
Participants will receive the WeCan-Rural intervention, which includes twelve sessions delivered remotely (i.e., videoconferencing) by a trained therapist.
干预措施: WeCan-Rural Program (Behavioral)
Control
Participants will receive the National Cancer Institute-developed booklet "Facing Forward: Life After Cancer Treatment," which presents information about cancer survivorship topics.
结局指标
主要结局
Satisfaction with Treatment and Interventionist as measured by the Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)
时间窗: Post-treatment (about 12-14 weeks after baseline)
Participants will complete the 13-item Satisfaction with Therapy and Therapist Scale-Revised specific to the program they received. The first 12 items ask participants to rate their agreement with statements related to intervention satisfaction on a 5-point scale ranging from "strongly disagree" (1) to "strongly agree" (5). The 13th item asks "How much did the intervention help with your symptoms?" with 5 answer choices ranging from "made things a lot better" to "made things a lot worse."
Acceptability as measured by the Treatment Acceptability Questionnaire
时间窗: Post-treatment (about 12-14 weeks after baseline)
The Treatment Acceptability Questionnaire is a six-item scale assessing participants' views of an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable") and averaged.
次要结局
- Change in blood pressure (systolic and diastolic)(From Baseline to Post-treatment (about 12-14 weeks after baseline))
- Change in weight(From Baseline to Post-treatment (about 12-14 weeks after baseline))
- Change in total cholesterol(From Baseline to Post-treatment (about 12-14 weeks after baseline))
- Change in LDL cholesterol(From Baseline to Post-treatment (about 12-14 weeks after baseline))
- Change in HDL cholesterol(From Baseline to Post-treatment (about 12-14 weeks after baseline))
- Change in hemoglobin A1c(From Baseline to Post-treatment (about 12-14 weeks after baseline))
- Change in C-reactive protein(From Baseline to Post-treatment (about 12-14 weeks after baseline))
- Change in high sensitivity troponin(From Baseline to Post-treatment (about 12-14 weeks after baseline))
- Change in aerobic capacity and endurance as measured by the 6-Minute Walk Test(From Baseline to Post-treatment (about 12-14 weeks after baseline))
- Pain severity and interference as measured by the Brief Pain Inventory(Baseline, Post-treatment (about 12-14 weeks after baseline))
- Emotional distress as measured by PROMIS Depression Short Form(Baseline, Post-treatment (about 12-14 weeks after baseline))
- Emotional distress as measured by PROMIS Anxiety Short Form(Baseline, Post-treatment (about 12-14 weeks after baseline))
- Fatigue as measured by PROMIS Fatigue Scale(Baseline, Post-treatment (about 12-14 weeks after baseline))
- Diet as measured by the Dietary Screener Questionnaire(Baseline, Post-treatment (about 12-14 weeks after baseline))
- Eating behavior as measured by the Three Factor Eating Questionnaire(Baseline, Post-treatment (about 12-14 weeks after baseline))
- Physical activity as measured by the Stanford Leisure-Time Activity Categorical Item (L-Cat)(Baseline, Post-treatment (about 12-14 weeks after baseline))
- Patient self-efficacy for chronic disease coping as measured by Self-Efficacy for Managing Chronic Illness Scale(Baseline, Post-treatment (about 12-14 weeks after baseline))
- Patient self-efficacy for managing chronic conditions as measured by the PROMIS Self-Efficacy for Managing Symptoms Short Form(Baseline, Post-treatment (about 12-14 weeks after baseline))
- Weight-related self-efficacy as measured by the Weight Efficacy Lifestyle Questionnaire(Baseline, Post-treatment (about 12-14 weeks after baseline))