A Prospective Study of a Lifestyle Medicine Survivorship Program for Patients With Gynecologic Cancer
Summary
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.
Detailed description
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.
Arms & interventions
- BehavioralHealthy Eating Active Lifestyle (HEAL): Gyn Cancer Program
Evidence-based lifestyle medicine program for cancer survivors
Outcome measures
Primary
Weight Efficacy Lifestyle (WEL) Questionnaire
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).
Time frame: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Secondary
Godin-Shephard Leisure-Time Physical Activity Questionnaire
Time frame: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Diet History Questionnaire III (DHQ III)
Time frame: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Body Image Scale
Time frame: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Perceived Stress Scale
Time frame: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Generalized Anxiety Disorder - 7-item scale (GAD-7)
Time frame: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Patient Health Questionnaire - 9-item scale (PHQ-9)
Time frame: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Functional Assessment of Cancer Therapy - General (FACT-G)
Time frame: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Height
Time frame: Baseline, 3-month follow up
Weight
Time frame: Baseline, 3-month follow up
Waist-to-hip ratio
Time frame: Baseline, 3-month follow up
Basic lab values
Time frame: Baseline, 3-month follow up
Adiponectin
Time frame: Baseline, 3-month follow up
Insulin sensitivity
Time frame: Baseline, 3-month follow up
Inflammatory markers
Time frame: Baseline, 3-month follow up
Physical activity minutes
Time frame: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Sleep minutes
Time frame: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Eligibility criteria
Study locations (1)
AdventHealth
Orlando, Florida, 32803
References
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