NCT07121738

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Dec 2025Aug 2026

First Submitted

Initial submission to the registry

August 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

December 8, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

March 3, 2026

Status Verified

November 1, 2025

Enrollment Period

9 months

First QC Date

August 7, 2025

Last Update Submit

March 2, 2026

Conditions

Gynecologic Cancers

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (17)

  • Godin-Shephard Leisure-Time Physical Activity Questionnaire

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

  • Diet History Questionnaire III (DHQ III)

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

  • Pittsburgh Sleep Quality Index (PSQI)

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

  • Body Image Scale

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

  • Perceived Stress Scale

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

  • +12 more secondary outcomes

Study Arms (1)

Behavioral

EXPERIMENTAL

Evidence-based lifestyle medicine program for cancer survivors

Behavioral: Healthy Eating Active Lifestyle (HEAL): Gyn Cancer Program

Interventions

Healthy Eating Active Lifestyle (HEAL): Gyn Cancer ProgramBEHAVIORAL

Evidence-based lifestyle medicine program for cancer survivors

Behavioral

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AdventHealth

Orlando, Florida, 32803, United States

RECRUITING

Related Publications (11)

  • 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: 39184272BACKGROUND

  • 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: 1955608BACKGROUND

  • 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

    BACKGROUND

  • 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: 11846115BACKGROUND

  • 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: 2748771BACKGROUND

  • 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: 8422297BACKGROUND

  • 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: 6668417BACKGROUND

  • 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: 16717171BACKGROUND

  • 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.

    PMID: 11556941BACKGROUND

  • 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.

    PMID: 14678568BACKGROUND

  • 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.

    PMID: 18841493BACKGROUND

Study Officials

  • Amanda T Sawyer, PhD

    AdventHealth

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda T Sawyer, PhD

CONTACT

407-200-2901Amanda.Sawyer@AdventHealth.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2025

First Posted

August 13, 2025

Study Start

December 8, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

March 3, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)