A Prospective Study of a Lifestyle Medicine Survivorship Program for Patients With Gynecologic Cancer (HEAL-GYN)

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancers
• Intervention / Treatment: Behavioral: Healthy Eating Active Lifestyle (HEAL): Gyn Cancer Program

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 Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amanda T Sawyer, PhD; Phone Number: 407-200-2901; Email: Amanda.Sawyer@AdventHealth.com

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • Recruiting
      • AdventHealth
      • Contact: Amanda T Sawyer, PhD; Phone Number: 407-200-2901; Email: Amanda.Sawyer@AdventHealth.com
      • Contact: Amy West, RN; Phone Number: 407-200-2901; Email: Amy.West@AdventHealth.com
      • Principal Investigator: Amanda' T Sawyer, PhD
      • Sub-Investigator: Nathalie McKenzie, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral; Evidence-based lifestyle medicine program for cancer survivors	Behavioral: Healthy Eating Active Lifestyle (HEAL): Gyn Cancer Program; Evidence-based lifestyle medicine program for cancer survivors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Godin-Shephard Leisure-Time Physical Activity Questionnaire	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.	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Diet History Questionnaire III (DHQ III)	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.	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Pittsburgh Sleep Quality Index (PSQI)	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.	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Body Image Scale	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.	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Perceived Stress Scale	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.	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Generalized Anxiety Disorder - 7-item scale (GAD-7)	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.	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Patient Health Questionnaire - 9-item scale (PHQ-9)	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.	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Functional Assessment of Cancer Therapy - General (FACT-G)	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.	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Height	Participant's standing height, measured in inches using a stadiometer or measuring tape.	Baseline, 3-month follow up
Weight	Participant's body weight, measured in pounds using a scale	Baseline, 3-month follow up
Waist-to-hip ratio	Ratio of waist circumference to hip circumference, both measured in inches using a tape measure.	Baseline, 3-month follow up
Basic lab values	Comprehensive Metabolic Panel; Blood lipid panel including Low-Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), and triglycerides; Hemoglobin A1c;	Baseline, 3-month follow up
Adiponectin	A blood biomarker (hormone), measured via blood sample.	Baseline, 3-month follow up
Insulin sensitivity	An index of how responsive the body is to insulin, measured via blood sample.	Baseline, 3-month follow up
Inflammatory markers	Includes C-reactive protein (CRP), Interleukin-6 (IL-6), and Tumor Necrosis Factor-alpha (TNF-α), measured via blood sample.	Baseline, 3-month follow up
Physical activity minutes	Objective measurement of daily minutes spent in light, moderate, and vigorous activity using a wearable activity tracker.	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up
Sleep minutes	Objective measurement of nightly minutes spent in light, deep, and REM sleep stages using a wearable activity tracker.	Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up

Collaborators and Investigators

• Sponsor: AdventHealth
• Collaborators: State of Florida Department of Health
• Investigators: Principal Investigator: Amanda T Sawyer, PhD, AdventHealth

Publications and helpful links

General Publications

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
• Clark MM, Abrams DB, Niaura RS, Eaton CA, Rossi JS. Self-efficacy in weight management. J Consult Clin Psychol. 1991 Oct;59(5):739-44. doi: 10.1037//0022-006x.59.5.739.
• Webster K, Cella D, Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: properties, applications, and interpretation. Health Qual Life Outcomes. 2003 Dec 16;1:79. doi: 10.1186/1477-7525-1-79.
• Thompson FE, Subar AF, Brown CC, Smith AF, Sharbaugh CO, Jobe JB, Mittl B, Gibson JT, Ziegler RG. Cognitive research enhances accuracy of food frequency questionnaire reports: results of an experimental validation study. J Am Diet Assoc. 2002 Feb;102(2):212-25. doi: 10.1016/s0002-8223(02)90050-7.
• McKenzie ND, Ahmad S. Impact of Lifestyle Interventions on Gynecologic Cancers: Beyond Diet and Exercise. Am J Lifestyle Med. 2022 Sep 14;18(1):7-20. doi: 10.1177/15598276221123764. eCollection 2024 Jan-Feb.
• Godin G. The Godin-Shephard Leisure-Time Physical Activity Questionnaire. Health Fitness J Can. 2011;4(1):18-22. doi:10.14288/hfjc.v4i1.82
• Hopwood P. The assessment of body image in cancer patients. Eur J Cancer. 1993;29A(2):276-81. doi: 10.1016/0959-8049(93)90193-j.
• Victorson D, Barocas J, Song J, Cella D. Reliability across studies from the functional assessment of cancer therapy-general (FACT-G) and its subscales: a reliability generalization. Qual Life Res. 2008 Nov;17(9):1137-46. doi: 10.1007/s11136-008-9398-2. Epub 2008 Oct 8.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: August 7, 2025
• First Submitted That Met QC Criteria: August 7, 2025
• First Posted (Actual): August 13, 2025

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2337720

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No