Breast Cancer
Conditions
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.
Interventions
BEHAVIORALHealthy Eating Active Lifestyle (HEAL) Program
Evidence-based lifestyle medicine program for cancer survivors
Sponsors
AdventHealth
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult ≥ 18 years old 2. Diagnosis of breast cancer 3. Enrolled in the HEAL: Breast Cancer Program 4. Able to speak, read, and understand English fluently 5. Willing and able to provide informed consent 6. Willing and able to comply with all study procedures and requirements for the duration of the study
Exclusion criteria
1. Not willing or able to provide informed consent 2. Not willing or able to comply with all study procedures and requirements for the duration of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Weight | Baseline, Week 8, 3-month follow up, 6-month follow up | Weight in kilograms |
| 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 |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmanda T. Sawyer, PhD
AdventHealth
Outcome results
None listed