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| Name | Class |
|---|---|
| State of Florida Department of Health | UNKNOWN |
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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.
This study will examine the effects of an 8-week intervention called the Healthy Eating Active Lifestyle (HEAL)-GYN program. This telemedicine-based rehabilitation course for patients with gynecologic cancer focuses on lifestyle changes in exercise, nutrition, sleep, social integration, stress management, and avoidance of risk behaviors, such as smoking and alcohol. Led by a certified lifestyle medicine oncologist, the multidisciplinary program includes personalized goal-setting and experiential instruction on these topics. A prospective study will be conducted with up to 64 participants who are patients with gynecologic cancer to examine the effects of the HEAL-GYN program on 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. Participants will complete a survey package at baseline, endpoint, 1-month follow-up, and 3-month follow-up timepoints, which includes the following validated instruments: Weight Efficacy Lifestyle Questionnaire, Godin-Shephard Leisure-Time Physical Activity Questionnaire, Diet History Questionnaire III, Pittsburgh Sleep Quality Index, Body Image Scale, Perceived Stress Scale, Generalized Anxiety Disorder 7-item scale (GAD-7), Patient Health Questionnaire 9-item scale (PHQ-9), and Functional Assessment of Cancer Therapy - General. Objective measurements of physical activity and sleep will be collected using a wearable activity tracker. During home health visits, data related to biometrics will be collected, along with basic lab values and biomarkers of adiponectin, insulin sensitivity, and inflammatory markers through blood samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral | Experimental | Evidence-based lifestyle medicine program for cancer survivors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Eating Active Lifestyle (HEAL): Gyn Cancer Program | Behavioral | Evidence-based lifestyle medicine program for cancer survivors |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda T Sawyer, PhD | Contact | 407-200-2901 | Amanda.Sawyer@AdventHealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Amanda T Sawyer, PhD | AdventHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth | Recruiting | Orlando | Florida | 32803 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39184272 | Background | 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. | |
| 1955608 | Background | 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. |
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| 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. | Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up |
| 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. | Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up |
| 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. | Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up |
| Perceived Stress Scale | A 10-item scale assessing the degree to which situations in one's life are appraised as stressful. Each item is rated from on a 5-point scale (0 = Never to 4 = Very Often) based on the frequency of feelings in the past month. A total score is computed (0-40). Higher scores indicate higher stress. | Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up |
| Generalized Anxiety Disorder - 7-item scale (GAD-7) | A 7-item screening questionnaire for generalized anxiety. Each item is rated on a 4-point scale (0 = Not at all to 3 = Nearly every day) for how often it occurred over the last 2 weeks. A total score is computed (0-21). Higher totals indicate more severe anxiety symptoms. | Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up |
| Patient Health Questionnaire - 9-item scale (PHQ-9) | A 9-item depression screening tool. Each item is rated on a 4-point scale (0 = Not at all to 3 = Nearly every day) for how often it occurred over the last 2 weeks. A total score is computed (0-27). Higher totals indicate more severe depressive symptoms. | Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up |
| Functional Assessment of Cancer Therapy - General (FACT-G) | A 27-item validated questionnaire measuring health-related quality of life in cancer patients across four domains: physical, social/family, emotional, and functional. Each item is rated on a 5-point scale (0 = Not at all to 4 = Very much). Domain scores are summed to calculate a total score. Higher scores indicate better quality of life. | Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up |
| Height | Participant's standing height, measured in inches using a stadiometer or measuring tape. | Baseline, 3-month follow up |
| Weight | Participant's body weight, measured in pounds using a scale | Baseline, 3-month follow up |
| Waist-to-hip ratio | Ratio of waist circumference to hip circumference, both measured in inches using a tape measure. | Baseline, 3-month follow up |
| Basic lab values | Comprehensive Metabolic Panel; Blood lipid panel including Low-Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), and triglycerides; Hemoglobin A1c; | Baseline, 3-month follow up |
| Adiponectin | A blood biomarker (hormone), measured via blood sample. | Baseline, 3-month follow up |
| Insulin sensitivity | An index of how responsive the body is to insulin, measured via blood sample. | Baseline, 3-month follow up |
| Inflammatory markers | Includes C-reactive protein (CRP), Interleukin-6 (IL-6), and Tumor Necrosis Factor-alpha (TNF-α), measured via blood sample. | Baseline, 3-month follow up |
| Physical activity minutes | Objective measurement of daily minutes spent in light, moderate, and vigorous activity using a wearable activity tracker. | Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up |
| Sleep minutes | Objective measurement of nightly minutes spent in light, deep, and REM sleep stages using a wearable activity tracker. | Baseline, Endpoint (week 8), 1-month follow-up, 3-month follow up |
| Background | 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 |
| 11846115 | 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. |
| 2748771 | Background | 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. |
| 8422297 | Background | 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. |
| 6668417 | Background | 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. |
| 16717171 | Background | 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. |
| 11556941 | Background | 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. |
| 14678568 | Background | 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. |
| 18841493 | Background | 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. |