Healthy Eating and Active Lifestyle (HEAL): Breast Cancer Program Outcomes

Study Overview
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Brief Summary
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The goal of this single-group prospective study is to examine the impact of the Healthy Eating and Active Lifestyle (HEAL) Breast Cancer program on participants' perceived stress, biometrics, basic labs, lifestyle behaviors, self-efficacy, mental health, and quality of life. Participants will participate in an 8-week program of 90-minute virtual sessions each week to decrease risk of cancer recurrence. Program participants can choose to participate in the research study which will include data collection (surveys, biometrics, basic labs). The data collection will occur at four timepoints - baseline prior to program start, post-program, 3 month follow-up, and 6 month follow-up.

Detailed Description
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The study will include 45 subjects recruited from AdventHealth Medical Group in the HEAL Breast Cancer Program that consent to participate in the research study. The research study will include data collection along with the program participation. Patients who decline participation in the research study are able to participate in the HEAL Breast Cancer Program. The program sessions will be conducted virtually via Zoom by Dr. Amber Orman, a breast cancer physician board certified in radiation oncology and lifestyle medicine. There are eight program sessions, one per week, each lasting 90-minutes. The survey package includes nine questionnaires and is expected to take 60 minutes to complete.

Official Title
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A Prospective Study of the Healthy Eating and Active Lifestyle (HEAL): Breast Cancer Program on Survivorship Outcomes

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Healthy Eating Active Lifestyle (HEAL) Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult ≥ 18 years old Diagnosis of breast cancer Enrolled in the HEAL: Breast Cancer Program Able to speak, read, and understand English fluently Willing and able to provide informed consent Willing and able to comply with all study procedures and requirements for the duration of the study Exclusion Criteria: Not willing or able to provide informed consent Not willing or able to comply with all study procedures and requirements for the duration of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Healthy Eating Active Lifestyle (HEAL) Program|Evidence-based lifestyle medicine program for cancer survivors|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale | PSS-10 is a ten item questionnaire covering the last month using 5 point Likert scale with 0 = Never, 1 = Almost never, 2 = Sometimes, 3 = Fairly often, 4 = Very often. | Baseline, Week 8, 3-month follow up, 6-month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mini-Eating Assessment Tool (mini-EAT) | mini-EAT is a 9-item validated brief dietary screener where participants indicate how often they eat food groups with 9 response options: I do not eat it at all, Less than 1 serving per week, 1-2 servings per week, 3-4 servings per week, 5-6 servings per week, 1 serving per day, 2-3 servings per day, 4-5 servings per day, 6 or more servings per day | Baseline, Week 8, 3-month follow up, 6-month follow up | 
| Godin-Shephard Leisure-Time Physical Activity Questionnaire | Godin-Shephard Leisure-Time Physical Activity Questionnaire includes 3 categories that participants indicate number of times in a week they participate | Baseline, Week 8, 3-month follow up, 6-month follow up | 
| General Self-Efficacy Scale | The GSE includes 10 items with response categories: 1 = not at all true, 2 = hardly true, 3 = moderately true and 4 = exactly true | Baseline, Week 8, 3-month follow up, 6-month follow up | 
| Generalized Anxiety Disorder - 2 item scale | The GAD-2 is a 2-item scale about the last 2 weeks with response categories: 0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day | Baseline, Week 8, 3-month follow up, 6-month follow up | 
| Patient Health Questionnaire - 2 item | The PHQ-2 is a 2-item scale about the last 2 weeks with response categories: 0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day | Baseline, Week 8, 3-month follow up, 6-month follow up | 
| Functional Assessment of Cancer Therapy - General - 7-item version | The FACT-G7 is a 7 item scale about the last 7 days with response categories: 0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much | Baseline, Week 8, 3-month follow up, 6-month follow up | 
| Weight | Weight in kilograms | Baseline, Week 8, 3-month follow up, 6-month follow up | 
| Body Mass Index | Body Mass Index (BMI) | Baseline, Week 8, 3-month follow up, 6-month follow up | 
| Blood pressure | Blood pressure both systolic and diastolic | Baseline, Week 8, 3-month follow up, 6-month follow up | 
| Lipid panel | Standard of care Lipid panel | Baseline, Week 8, 3-month follow up, 6-month follow up | 
| Comprehensive metabolic panel | Standard of care Comprehensive metabolic panel | Baseline, Week 8, 3-month follow up, 6-month follow up | 
| Hemoglobin A1C | Standard of care Hemoglobin A1C | Baseline, Week 8, 3-month follow up, 6-month follow up |