A Prospective Study of a Lifestyle Medicine Survivorship Program for Patients With Gynecologic Cancer

Not Applicable

Not yet recruiting

• Conditions: Gynecologic Cancers

• Registration Number: NCT07121738
• Lead Sponsor: AdventHealth

Brief 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Study Start: 2025-09-01
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Weight Efficacy Lifestyle (WEL) Questionnaire	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).

Secondary Outcome Measures

Name	Time	Method
Godin-Shephard Leisure-Time Physical Activity Questionnaire	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up	A 3-item self-report questionnaire asking the number of times per week one engages in strenuous, moderate, and mild leisure exercise. Participants enter frequency counts for each category, which are used to compute a weekly activity score. Higher scores indicate higher physical activity level.
Diet History Questionnaire III (DHQ III)	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up	A \~130-item food frequency questionnaire collecting dietary intake information. Participants report how often they consume various foods and beverages and sometimes portion size. It measures habitual dietary intake and nutrient consumption patterns.
Pittsburgh Sleep Quality Index (PSQI)	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up	A 19-item questionnaire assessing habitual sleep quality over the past month in terms of bedtime, sleep latency, duration, efficiency, disturbances, use of sleep aids, and daytime dysfunction. Each item is rated on a 4-point scale (0 = Not during the past month to 3 = ≥3 times/week). A total score is computed (0-21). Higher scores indicate poorer sleep quality.
Body Image Scale	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up	A 10-item self-report scale developed for cancer patients to evaluate body image changes. Each item is rated on a 4-point scale (0 = Not at all to 3 = Very much). A total score is computed (0-30). Higher scores indicate greater body image disturbance or dissatisfaction.
Perceived Stress Scale	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up	A 10-item scale assessing the degree to which situations in one's life are appraised as stressful. Each item is rated from on a 5-point scale (0 = Never to 4 = Very Often) based on the frequency of feelings in the past month. A total score is computed (0-40). Higher scores indicate higher stress.
Generalized Anxiety Disorder - 7-item scale (GAD-7)	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up	A 7-item screening questionnaire for generalized anxiety. Each item is rated on a 4-point scale (0 = Not at all to 3 = Nearly every day) for how often it occurred over the last 2 weeks. A total score is computed (0-21). Higher totals indicate more severe anxiety symptoms.
Patient Health Questionnaire - 9-item scale (PHQ-9)	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up	A 9-item depression screening tool. Each item is rated on a 4-point scale (0 = Not at all to 3 = Nearly every day) for how often it occurred over the last 2 weeks. A total score is computed (0-27). Higher totals indicate more severe depressive symptoms.
Functional Assessment of Cancer Therapy - General (FACT-G)	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up	A 27-item validated questionnaire measuring health-related quality of life in cancer patients across four domains: physical, social/family, emotional, and functional. Each item is rated on a 5-point scale (0 = Not at all to 4 = Very much). Domain scores are summed to calculate a total score. Higher scores indicate better quality of life.
Height	Baseline, 3-month follow up	Participant's standing height, measured in inches using a stadiometer or measuring tape.
Weight	Baseline, 3-month follow up	Participant's body weight, measured in pounds using a scale
Waist-to-hip ratio	Baseline, 3-month follow up	Ratio of waist circumference to hip circumference, both measured in inches using a tape measure.
Basic lab values	Baseline, 3-month follow up	Comprehensive Metabolic Panel; Blood lipid panel including Low-Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), and triglycerides; Hemoglobin A1c;
Adiponectin	Baseline, 3-month follow up	A blood biomarker (hormone), measured via blood sample.
Insulin sensitivity	Baseline, 3-month follow up	An index of how responsive the body is to insulin, measured via blood sample.
Inflammatory markers	Baseline, 3-month follow up	Includes C-reactive protein (CRP), Interleukin-6 (IL-6), and Tumor Necrosis Factor-alpha (TNF-α), measured via blood sample.
Physical activity minutes	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up	Objective measurement of daily minutes spent in light, moderate, and vigorous activity using a wearable activity tracker.
Sleep minutes	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up	Objective measurement of nightly minutes spent in light, deep, and REM sleep stages using a wearable activity tracker.

Trial Locations

Locations (1)

AdventHealth; 🇺🇸 Orlando, Florida, United States