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

NCT ID: NCT06078761

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-21

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Healthy Eating Active Lifestyle (HEAL) Program

Evidence-based lifestyle medicine program for cancer survivors

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AdventHealth

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amanda T. Sawyer, PhD

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Locations

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AdventHealth

Orlando, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amanda T. Sawyer, PhD

Role: CONTACT

407-200-2901

Tere Richard, MHSA

Role: CONTACT

407-200-2901

Facility Contacts

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Amanda Sawyer, PhD

Role: primary

Tere Richard, MHSA

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 6668417 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 17339617 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14583691 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36583423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31184787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32922233 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30202290 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 23136235 (View on PubMed)

Other Identifiers

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2056943

Identifier Type: -

Identifier Source: org_study_id

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