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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Healthy Eating Active Lifestyle (HEAL): Gyn Cancer Program
BehavioralEvidence-based lifestyle medicine program for cancer survivors
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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AdventHealth
Lead sponsor
State of Florida Department of Health
Collaborator