NCT06078761

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

September 27, 2023

Last Update Submit

March 11, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • mini-Eating Assessment Tool (mini-EAT)

    Baseline, Week 8, 3-month follow up, 6-month follow up

  • Godin-Shephard Leisure-Time Physical Activity Questionnaire

    Baseline, Week 8, 3-month follow up, 6-month follow up

  • General Self-Efficacy Scale

    Baseline, Week 8, 3-month follow up, 6-month follow up

  • Generalized Anxiety Disorder - 2 item scale

    Baseline, Week 8, 3-month follow up, 6-month follow up

  • Patient Health Questionnaire - 2 item

    Baseline, Week 8, 3-month follow up, 6-month follow up

  • +7 more secondary outcomes

Interventions

Healthy Eating Active Lifestyle (HEAL) ProgramBEHAVIORAL

Evidence-based lifestyle medicine program for cancer survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Adult ≥ 18 years old
  • Diagnosis of breast cancer
  • Enrolled in the HEAL: Breast Cancer Program
  • Able to speak, read, and understand English fluently
  • Willing and able to provide informed consent
  • Willing and able to comply with all study procedures and requirements for the duration of the study

You may not qualify if:

  • Not willing or able to provide informed consent
  • Not willing or able to comply with all study procedures and requirements for the duration of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AdventHealth

Orlando, Florida, 32804, United States

Location

Related Publications (10)

  • 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.

    PMID: 6668417BACKGROUND

  • 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

    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.

    PMID: 17339617BACKGROUND

  • 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.

    PMID: 14583691BACKGROUND

  • 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.

    PMID: 36583423BACKGROUND

  • 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.

    PMID: 31184787BACKGROUND

  • 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.

    PMID: 32922233BACKGROUND

  • 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.

    PMID: 30202290BACKGROUND

  • 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.

    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.

    PMID: 23136235BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Wound Healing

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RegenerationBiological Phenomena

Study Officials

  • Amanda T. Sawyer, PhD

    AdventHealth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 12, 2023

Study Start

September 21, 2023

Primary Completion

November 1, 2025

Study Completion

February 26, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)