Lifestyle Medicine Program for Gynecologic Cancer

(HEAL-GYN Trial)

Overseen By Amanda T Sawyer, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: AdventHealth

Disqualifiers: Informed consent, Study compliance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an 8-week program called the Healthy Eating Active Lifestyle (HEAL)-GYN, designed for women diagnosed with gynecologic cancer. The program aims to assess its impact on participants' confidence in managing their health, physical activity, diet, mental health, and overall well-being. It also examines changes in health indicators, such as biometrics and biomarkers. Ideal candidates have recently completed cancer treatment, reside in Central Florida, and speak English. Participants should have finished chemotherapy within the past three months. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance post-treatment recovery and quality of life.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the Healthy Eating Active Lifestyle (HEAL)-GYN program is safe for participants?

Research has shown that the Healthy Eating Active Lifestyle (HEAL)-GYN program is safe for participants. In a study with cancer survivors, participants experienced reduced stress and anxiety and improved health without serious side effects. Another study on a similar program found that women who improved their diet and exercised regularly lived longer, healthier lives. These findings suggest that the HEAL-GYN program is well-tolerated and can lead to positive health changes. As the program involves changes in diet and exercise, it is generally considered safe and aims to enhance overall well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Healthy Eating Active Lifestyle (HEAL): Gyn Cancer Program because it introduces an evidence-based lifestyle medicine approach for cancer survivors. Unlike traditional treatments for gynecologic cancer, which often focus on surgery, chemotherapy, or radiation, this program emphasizes the benefits of healthy eating and physical activity to improve quality of life and potentially reduce cancer recurrence. By empowering survivors with practical lifestyle changes, the program aims to provide a holistic, non-invasive complement to conventional cancer therapies.

What evidence suggests that the HEAL-GYN program is effective for gynecologic cancer?

Research has shown that lifestyle changes can greatly benefit cancer survivors. In one study, participants in the Healthy Eating Active Lifestyle (HEAL) program, which participants in this trial will follow, reported feeling much less stressed and anxious. This program emphasizes healthy eating and regular exercise, which can lower the risk of gynecologic cancers. For example, exercising alone can reduce the risk of endometrial cancer by 20-30%. These early findings suggest that a healthy lifestyle can boost mental health and overall well-being for those recovering from gynecologic cancers. ^{6 7 8 9 10}

Who Is on the Research Team?

Amanda T Sawyer, PhD

Principal Investigator

AdventHealth

Are You a Good Fit for This Trial?

This trial is for adults over 18 in Central Florida who have been diagnosed with gynecologic cancer and are finishing or have recently finished chemotherapy. Participants must speak English and be willing to follow the study procedures.

Inclusion Criteria

Current patient in the Central Florida area

I have been diagnosed with a cancer that affects the female reproductive organs.

I am 18 years old or older.

Exclusion Criteria

Not willing or able to provide informed consent

I am unable or unwilling to follow the study's procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week telemedicine-based rehabilitation course focusing on lifestyle changes in exercise, nutrition, sleep, social integration, stress management, and avoidance of risk behaviors.

8 weeks

Telemedicine sessions

Follow-up

Participants are monitored for self-efficacy, lifestyle factors, mental health, and biometrics at 1-month and 3-month follow-up timepoints.

3 months

Surveys and home health visits

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The HEAL-GYN program, an 8-week lifestyle intervention focusing on diet, physical activity, mental health, and overall well-being is being tested. The effects on self-efficacy, lifestyle changes, and various health markers will be studied.

How Is the Trial Designed?

Group I: Behavioral Experimental Treatment 1 Intervention

Evidence-based lifestyle medicine program for cancer survivors

Who Is Running the Clinical Trial?

AdventHealth

Lead Sponsor

Trials

118

Recruited

31,800+

State of Florida Department of Health

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07121738

A Prospective Study of a Lifestyle Medicine Survivorship ... This study will examine the effects of an 8-week intervention called the Healthy Eating Active Lifestyle (HEAL)-GYN program. This telemedicine-based ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11923587/

Development of tele-lifestyle-based multidisciplinary ... Participants reported a statistically significant improvement along several parameters, specifically, perceived stress, levels of anxiety, and ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.e24033

Feasibility of a telemedicine lifestyle-based rehabilitation ... The Healthy Eating Active Lifestyle (HEAL) – GYN “rehabilitation” cancer program was developed to provide intensive group lifestyle training on ...

4. withpower.com withpower.com/trial/phase-gynecologic-cancers-8-2025-e2ebb

Lifestyle Medicine Program for Gynecologic Cancer (HEAL ... 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11339763/

Impact of Lifestyle Interventions on Gynecologic Cancers Physical activity is associated with decreased risk of gynecologic cancers. Exercise has demonstrated a 20-30% risk reduction of endometrial cancer in women who ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07121738

A Prospective Study of a Lifestyle Medicine Survivorship ... This study will examine the effects of an 8-week intervention called the Healthy Eating Active Lifestyle (HEAL)-GYN program. This telemedicine-based ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12033087/

Healthy lifestyle behaviors and gynecological cancer ... This study highlights that HLB and GCA levels are associated with working position, exercising regularly, consuming regular meals and snacks, ...

8. academic.oup.com academic.oup.com/oncolo/article/30/3/oyaf033/8087942

Development of tele-lifestyle-based multidisciplinary ... Participants reported a statistically significant improvement along several parameters, specifically, perceived stress, levels of anxiety, and ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714416301057

A randomized trial of diet and physical activity in women ... One study (n = 636 cases) showed 27% lower mortality in women reporting a high diet quality score – a score that reflected greater vegetable, fruit, and fiber ...

10. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(22)02017-0/fulltext

Lifestyle intervention in ovarian cancer enhanced survival ... Lifestyle factors -diet and physical activity- may improve survival for ovarian cancer survivors. •. This randomized controlled trial (N=1205) ovarian cancer ...