A Prospective Study of a Lifestyle Medicine Survivorship Program for Patients With Gynecologic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AdventHealth
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Weight Efficacy Lifestyle (WEL) Questionnaire
研究概览
简要总结
This study will examine the effects of an 8-week intervention called the Healthy Eating Active Lifestyle (HEAL)-GYN program on participants' 1) self-efficacy 2) lifestyle factors, including physical activity and diet, as well as mental health and overall well-being, and 3) biometrics and biomarkers.
详细描述
This study will examine the effects of an 8-week intervention called the Healthy Eating Active Lifestyle (HEAL)-GYN program. This telemedicine-based rehabilitation course for patients with gynecologic cancer focuses on lifestyle changes in exercise, nutrition, sleep, social integration, stress management, and avoidance of risk behaviors, such as smoking and alcohol. Led by a certified lifestyle medicine oncologist, the multidisciplinary program includes personalized goal-setting and experiential instruction on these topics. A prospective study will be conducted with up to 64 participants who are patients with gynecologic cancer to examine the effects of the HEAL-GYN program on 1) self-efficacy 2) lifestyle factors, including physical activity and diet, as well as mental health and overall well-being, and 3) biometrics and biomarkers. Participants will complete a survey package at baseline, endpoint, 1-month follow-up, and 3-month follow-up timepoints, which includes the following validated instruments: Weight Efficacy Lifestyle Questionnaire, Godin-Shephard Leisure-Time Physical Activity Questionnaire, Diet History Questionnaire III, Pittsburgh Sleep Quality Index, Body Image Scale, Perceived Stress Scale, Generalized Anxiety Disorder 7-item scale (GAD-7), Patient Health Questionnaire 9-item scale (PHQ-9), and Functional Assessment of Cancer Therapy - General. Objective measurements of physical activity and sleep will be collected using a wearable activity tracker. During home health visits, data related to biometrics will be collected, along with basic lab values and biomarkers of adiponectin, insulin sensitivity, and inflammatory markers through blood samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult 18 years old or over
- •Diagnosis of gynecologic cancer
- •Current patient in the Central Florida area
- •Completing or have completed chemotherapy treatment within approximately the past 3 months before starting the program
- •Able to speak, read, and understand the English language.
排除标准
- •Not willing or able to provide informed consent
- •Not willing or able to comply with all study procedures and requirement for the duration of the study
研究组 & 干预措施
Behavioral
Evidence-based lifestyle medicine program for cancer survivors
干预措施: Healthy Eating Active Lifestyle (HEAL): Gyn Cancer Program (Behavioral)
结局指标
主要结局
Weight Efficacy Lifestyle (WEL) Questionnaire
时间窗: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
A 20-item questionnaire measuring eating self-efficacy across five domains: negative emotions, availability, social pressure, physical discomfort, and positive activities. Each item is rated on a 10-point scale (0 = Not confident, 9 = Very confident) for the participant's ability to resist overeating in various situations. Higher scores indicate greater confidence in managing eating behaviors (higher eating self-efficacy).
次要结局
- Insulin sensitivity(Baseline, 3-month follow up)
- Godin-Shephard Leisure-Time Physical Activity Questionnaire(Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up)
- Diet History Questionnaire III (DHQ III)(Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up)
- Body Image Scale(Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up)
- Perceived Stress Scale(Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up)
- Generalized Anxiety Disorder - 7-item scale (GAD-7)(Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up)
- Patient Health Questionnaire - 9-item scale (PHQ-9)(Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up)
- Functional Assessment of Cancer Therapy - General (FACT-G)(Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up)
- Height(Baseline, 3-month follow up)
- Weight(Baseline, 3-month follow up)
- Waist-to-hip ratio(Baseline, 3-month follow up)
- Basic lab values(Baseline, 3-month follow up)
- Adiponectin(Baseline, 3-month follow up)
- Inflammatory markers(Baseline, 3-month follow up)
- Physical activity minutes(Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up)
- Sleep minutes(Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up)