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.
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.
Study Type
OBSERVATIONAL
Enrollment
22
Evidence-based lifestyle medicine program for cancer survivors
AdventHealth
Orlando, Florida, United States
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.
Time frame: Baseline, Week 8, 3-month follow up, 6-month follow up
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 8, 3-month follow up, 6-month follow up
Weight
Weight in kilograms
Time frame: Baseline, Week 8, 3-month follow up, 6-month follow up
Body Mass Index
Body Mass Index (BMI)
Time frame: Baseline, Week 8, 3-month follow up, 6-month follow up
Blood pressure
Blood pressure both systolic and diastolic
Time frame: Baseline, Week 8, 3-month follow up, 6-month follow up
Lipid panel
Standard of care Lipid panel
Time frame: Baseline, Week 8, 3-month follow up, 6-month follow up
Comprehensive metabolic panel
Standard of care Comprehensive metabolic panel
Time frame: Baseline, Week 8, 3-month follow up, 6-month follow up
Hemoglobin A1C
Standard of care Hemoglobin A1C
Time frame: Baseline, Week 8, 3-month follow up, 6-month follow up
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