Healthy Eating and Active Lifestyle (HEAL): Breast Cancer Program Outcomes

Breast Cancer Clinical Trial

— HEAL BC  

Official title:

A Prospective Study of the Healthy Eating and Active Lifestyle (HEAL): Breast Cancer Program on Survivorship Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06078761
• Other study ID #: 2056943
• Status: Recruiting
• Start date: September 21, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: AdventHealth
• Contact: Amanda T. Sawyer, PhD
• Phone: 407-200-2901
• Email: amanda.sawyer[@]adventhealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Healthy Eating Active Lifestyle (HEAL) Program
Evidence-based lifestyle medicine program for cancer survivors

Locations

Country	Name	City	State
United States	AdventHealth	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AdventHealth

Country where clinical trial is conducted

United States, 

References & Publications (10)

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

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.

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Weight	Weight in kilograms	Baseline, Week 8, 3-month follow up, 6-month follow up
Secondary	Body Mass Index	Body Mass Index (BMI)	Baseline, Week 8, 3-month follow up, 6-month follow up
Secondary	Blood pressure	Blood pressure both systolic and diastolic	Baseline, Week 8, 3-month follow up, 6-month follow up
Secondary	Lipid panel	Standard of care Lipid panel	Baseline, Week 8, 3-month follow up, 6-month follow up
Secondary	Comprehensive metabolic panel	Standard of care Comprehensive metabolic panel	Baseline, Week 8, 3-month follow up, 6-month follow up
Secondary	Hemoglobin A1C	Standard of care Hemoglobin A1C	Baseline, Week 8, 3-month follow up, 6-month follow up