Healthy Eating and Active Lifestyle (HEAL): Breast Cancer Program Outcomes
- Conditions
- Breast Cancer
- Registration Number
- NCT06078761
- Lead Sponsor
- AdventHealth
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Perceived Stress Scale Baseline, Week 8, 3-month follow up, 6-month follow up 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.
- Secondary Outcome Measures
Name Time Method mini-Eating Assessment Tool (mini-EAT) Baseline, Week 8, 3-month follow up, 6-month follow up 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
Comprehensive metabolic panel Baseline, Week 8, 3-month follow up, 6-month follow up Standard of care Comprehensive metabolic panel
Hemoglobin A1C Baseline, Week 8, 3-month follow up, 6-month follow up Standard of care Hemoglobin A1C
Weight Baseline, Week 8, 3-month follow up, 6-month follow up Weight in kilograms
Godin-Shephard Leisure-Time Physical Activity Questionnaire Baseline, Week 8, 3-month follow up, 6-month follow up Godin-Shephard Leisure-Time Physical Activity Questionnaire includes 3 categories that participants indicate number of times in a week they participate
Generalized Anxiety Disorder - 2 item scale Baseline, Week 8, 3-month follow up, 6-month follow up 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
Patient Health Questionnaire - 2 item Baseline, Week 8, 3-month follow up, 6-month follow up 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
Functional Assessment of Cancer Therapy - General - 7-item version Baseline, Week 8, 3-month follow up, 6-month follow up 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
General Self-Efficacy Scale Baseline, Week 8, 3-month follow up, 6-month follow up The GSE includes 10 items with response categories: 1 = not at all true, 2 = hardly true, 3 = moderately true and 4 = exactly true
Body Mass Index Baseline, Week 8, 3-month follow up, 6-month follow up Body Mass Index (BMI)
Blood pressure Baseline, Week 8, 3-month follow up, 6-month follow up Blood pressure both systolic and diastolic
Lipid panel Baseline, Week 8, 3-month follow up, 6-month follow up Standard of care Lipid panel
Trial Locations
- Locations (1)
AdventHealth
🇺🇸Orlando, Florida, United States