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

Overview

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.

Interventions

• Behavioral Healthy Eating Active Lifestyle (HEAL): Gyn Cancer Program
  Evidence-based lifestyle medicine program for cancer survivors

Primary outcome measures

• Weight Efficacy Lifestyle (WEL) Questionnaire [Time frame: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• AdventHealth — Orlando

Publications

• 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. PMID 39184272
• 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. PMID 1955608
• 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
• 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. PMID 11846115
• 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. PMID 2748771
• 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. PMID 8422297
• 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. PMID 6668417
• 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. PMID 16717171

Identifiers

NCT: NCT07121738 · 2337720

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗