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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAdventHealth

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

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

    Behavioral

    Evidence-based lifestyle medicine program for cancer survivors

Treatment groups

64 Participants
are divided into 1 treatment group
Group A: BehavioralExperimental treatment 1 intervention

Trial outcomes

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).

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

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AdventHealth

Lead sponsor

State of Florida Department of Health

Collaborator