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Gynecologic CancersHEAL-GYNNCT07121738

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

A study testing Healthy Eating Active Lifestyle (HEAL): Gyn Cancer Program in people with Gynecologic Cancers, run by AdventHealth at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Gynecologic Cancers
What is being tested?
Healthy Eating Active Lifestyle (HEAL): Gyn Cancer Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteUnited States
Study dates
8 Dec 2025to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • AdventHealth

    Orlando, Florida, 32803

Other trials in United States

About this study

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.

Read the 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.

Being tested
Healthy Eating Active Lifestyle (HEAL): Gyn Cancer Program

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy Eating Active Lifestyle (HEAL): Gyn Cancer ProgramBehavioural

    Evidence-based lifestyle medicine program for cancer survivors

Study groups in NCT07121738
Study groupRoleWhat they receive
BehavioralExperimentalEvidence-based lifestyle medicine program for cancer survivors
Receives: Behavioral: Healthy Eating Active Lifestyle (HEAL): Gyn Cancer Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up

Secondary outcomes (17)

  1. 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.

    Measured: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up

  2. 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.

    Measured: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up

  3. 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.

    Measured: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up

  4. 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.

    Measured: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up

  5. 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.

    Measured: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up

  6. 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.

    Measured: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up

  7. 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.

    Measured: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up

  8. 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.

    Measured: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up

  9. Height

    Participant's standing height, measured in inches using a stadiometer or measuring tape.

    Measured: Baseline, 3-month follow up

  10. Weight

    Participant's body weight, measured in pounds using a scale

    Measured: Baseline, 3-month follow up

  11. Waist-to-hip ratio

    Ratio of waist circumference to hip circumference, both measured in inches using a tape measure.

    Measured: Baseline, 3-month follow up

  12. Basic lab values

    Comprehensive Metabolic Panel; Blood lipid panel including Low-Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), and triglycerides; Hemoglobin A1c;

    Measured: Baseline, 3-month follow up

  13. Adiponectin

    A blood biomarker (hormone), measured via blood sample.

    Measured: Baseline, 3-month follow up

  14. Insulin sensitivity

    An index of how responsive the body is to insulin, measured via blood sample.

    Measured: Baseline, 3-month follow up

  15. Inflammatory markers

    Includes C-reactive protein (CRP), Interleukin-6 (IL-6), and Tumor Necrosis Factor-alpha (TNF-α), measured via blood sample.

    Measured: Baseline, 3-month follow up

  16. Physical activity minutes

    Objective measurement of daily minutes spent in light, moderate, and vigorous activity using a wearable activity tracker.

    Measured: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up

  17. Sleep minutes

    Objective measurement of nightly minutes spent in light, deep, and REM sleep stages using a wearable activity tracker.

    Measured: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2025
  2. Study start8 Dec 2025
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07121738
Sponsor's protocol ID
2337720
Acronym
HEAL-GYN
Status last verified
Oct 2026
First submitted
7 Aug 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 16717171

  • 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.

    PubMed 11556941

  • 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.

    PubMed 14678568

  • 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.

    PubMed 18841493

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Eating Active Lifestyle (HEAL): Gyn Cancer Program in people with Gynecologic Cancers, run by AdventHealth at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Efficacy Lifestyle (WEL) Questionnaire (time frame: Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07121738, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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