Clinical trial NCT06078761: Healthy Eating and Active Lifestyle (HEAL): Breast Cancer Program Outcomes
Official title: A Prospective Study of the Healthy Eating and Active Lifestyle (HEAL): Breast Cancer Program on Survivorship Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer survivors recruited from the AdventHealth Medical Group that were referred to attend the Healthy Eating and Active Lifestyle Breast Cancer Program.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: Baseline, Week 8, 3-month follow up, 6-month follow up
Secondary outcomes:
measure: mini-Eating Assessment Tool (mini-EAT)
timeFrame: Baseline, Week 8, 3-month follow up, 6-month follow up
measure: Godin-Shephard Leisure-Time Physical Activity Questionnaire
timeFrame: Baseline, Week 8, 3-month follow up, 6-month follow up
measure: General Self-Efficacy Scale
timeFrame: Baseline, Week 8, 3-month follow up, 6-month follow up
measure: Generalized Anxiety Disorder - 2 item scale
timeFrame: Baseline, Week 8, 3-month follow up, 6-month follow up
measure: Patient Health Questionnaire - 2 item
timeFrame: Baseline, Week 8, 3-month follow up, 6-month follow up
measure: Functional Assessment of Cancer Therapy - General - 7-item version
timeFrame: Baseline, Week 8, 3-month follow up, 6-month follow up
measure: Weight
timeFrame: Baseline, Week 8, 3-month follow up, 6-month follow up
measure: Body Mass Index
timeFrame: Baseline, Week 8, 3-month follow up, 6-month follow up
measure: Blood pressure
timeFrame: Baseline, Week 8, 3-month follow up, 6-month follow up
measure: Lipid panel
timeFrame: Baseline, Week 8, 3-month follow up, 6-month follow up
measure: Comprehensive metabolic panel
timeFrame: Baseline, Week 8, 3-month follow up, 6-month follow up
measure: Hemoglobin A1C
timeFrame: Baseline, Week 8, 3-month follow up, 6-month follow up
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth
state: Florida
Study officials:
affiliation: AdventHealth
name: Amanda T. Sawyer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.