HEAL‑GYN lifestyle survivorship program for people with gynecologic cancer
A Prospective Study of a Lifestyle Medicine Survivorship Program for Patients With Gynecologic Cancer
This 8-week telemedicine program will test whether personalized lifestyle coaching on exercise, diet, sleep, stress, and social connection helps adults with gynecologic cancer improve habits, mental health, and health measures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | AdventHealth Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT07121738 on ClinicalTrials.gov |
What this trial studies
Participants will take part in an 8-week Healthy Eating Active Lifestyle (HEAL)-GYN program delivered by a certified lifestyle medicine oncologist and a multidisciplinary team, using telemedicine sessions, personalized goal-setting, and experiential instruction on exercise, nutrition, sleep, stress management, social integration, and avoidance of risk behaviors. Up to 64 adult patients with gynecologic cancer who are current patients in Central Florida and recently completed or are completing chemotherapy will be enrolled in this prospective intervention. Outcomes are measured by validated questionnaires (for example PHQ-9, GAD-7, Pittsburgh Sleep Quality Index, Godin-Shephard physical activity, Diet History Questionnaire III, and Functional Assessment of Cancer Therapy), wearable activity/sleep trackers, and biometric/biomarker data collected at baseline, end of program, 1-month, and 3-month follow-ups. The program is run through AdventHealth in Orlando and includes remote monitoring and telehealth sessions to support behavior change.
Who should consider this trial
Good fit: Adults (18+) with a diagnosis of gynecologic cancer who are current patients in the Central Florida area, English-speaking, and completing or within about three months of finishing chemotherapy are ideal candidates.
Not a fit: Patients unwilling or unable to consent or comply with study procedures, non-English speakers, or those who cannot participate via telemedicine or are outside the Central Florida catchment area are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could improve participants' confidence to manage health behaviors, increase physical activity and better diet, reduce stress and anxiety, and improve biometrics and overall well-being during survivorship.
How similar studies have performed: Lifestyle and rehabilitation programs for cancer survivors have previously shown improvements in physical activity, diet, and quality of life in other cancer types, but HEAL‑GYN is a novel, telemedicine-focused program specifically tailored to gynecologic cancer patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Orlando, Florida
- AdventHealth — Orlando, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Amanda T Sawyer, PhD — AdventHealth
- Study coordinator: Amanda T Sawyer, PhD
- Email: Amanda.Sawyer@AdventHealth.com
- Phone: 407-200-2901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.