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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Eating Active Lifestyle (HEAL) Program | Behavioral | Evidence-based lifestyle medicine program for cancer survivors |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Breast cancer survivors recruited from the AdventHealth Medical Group that were referred to attend the Healthy Eating and Active Lifestyle Breast Cancer Program.
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| Name | Affiliation | Role |
|---|---|---|
| Amanda T. Sawyer, PhD | AdventHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth | Orlando | Florida | 32804 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| Background | 2. Godin, G. (2011). The Godin-Shephard Leisure-Time Physical Activity Questionnaire. The Health & Fitness Journal of Canada, 4(1), 18-22. https://doi.org/10.14288/hfjc.v4i1.82 | ||
| 17339617 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D014945 | Wound Healing |
| ID | Term |
|---|---|
| D012038 | Regeneration |
| D001686 | Biological Phenomena |
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| 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 |
| Background |
| Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004. |
| 14583691 | Background | Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C. |
| 36583423 | Background | Lara-Breitinger KM, Medina Inojosa JR, Li Z, Kunzova S, Lerman A, Kopecky SL, Lopez-Jimenez F. Validation of a Brief Dietary Questionnaire for Use in Clinical Practice: Mini-EAT (Eating Assessment Tool). J Am Heart Assoc. 2023 Jan 3;12(1):e025064. doi: 10.1161/JAHA.121.025064. Epub 2022 Dec 30. |
| 31184787 | Background | Miller KD, Nogueira L, Mariotto AB, Rowland JH, Yabroff KR, Alfano CM, Jemal A, Kramer JL, Siegel RL. Cancer treatment and survivorship statistics, 2019. CA Cancer J Clin. 2019 Sep;69(5):363-385. doi: 10.3322/caac.21565. Epub 2019 Jun 11. |
| 32922233 | Background | Orman A, Johnson DL, Comander A, Brockton N. Breast Cancer: A Lifestyle Medicine Approach. Am J Lifestyle Med. 2020 Apr 26;14(5):483-494. doi: 10.1177/1559827620913263. eCollection 2020 Sep-Oct. |
| 30202290 | Background | Patel Saxena S. Leveraging Time With Lifestyle-Based Group Visits. Am J Lifestyle Med. 2016 Jun 23;10(5):330-337. doi: 10.1177/1559827616638018. eCollection 2016 Sep-Oct. |
| Background | 9. Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy Scale. J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs, 35, 37. |
| 23136235 | Background | Yanez B, Pearman T, Lis CG, Beaumont JL, Cella D. The FACT-G7: a rapid version of the functional assessment of cancer therapy-general (FACT-G) for monitoring symptoms and concerns in oncology practice and research. Ann Oncol. 2013 Apr;24(4):1073-8. doi: 10.1093/annonc/mds539. Epub 2012 Nov 7. |
| D017437 |
| Skin and Connective Tissue Diseases |