A Prospective Study of a Lifestyle Medicine Survivorship Program for Patients With Gynecologic Cancer (HEAL-GYN)
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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.
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
64 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Amanda T Sawyer, PhD
Data sourced from clinicaltrials.gov
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