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

March 11, 2026 updated by: AdventHealth

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • AdventHealth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale
Time Frame: Baseline, Week 8, 3-month follow up, 6-month follow up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
mini-Eating Assessment Tool (mini-EAT)
Time Frame: Baseline, Week 8, 3-month follow up, 6-month follow up
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
Godin-Shephard Leisure-Time Physical Activity Questionnaire
Time Frame: Baseline, Week 8, 3-month follow up, 6-month follow up
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
Time Frame: Baseline, Week 8, 3-month follow up, 6-month follow up
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
Time Frame: Baseline, Week 8, 3-month follow up, 6-month follow up
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
Time Frame: Baseline, Week 8, 3-month follow up, 6-month follow up
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
Time Frame: Baseline, Week 8, 3-month follow up, 6-month follow up
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
Time Frame: Baseline, Week 8, 3-month follow up, 6-month follow up
Weight in kilograms
Baseline, Week 8, 3-month follow up, 6-month follow up
Body Mass Index
Time Frame: Baseline, Week 8, 3-month follow up, 6-month follow up
Body Mass Index (BMI)
Baseline, Week 8, 3-month follow up, 6-month follow up
Blood pressure
Time Frame: Baseline, Week 8, 3-month follow up, 6-month follow up
Blood pressure both systolic and diastolic
Baseline, Week 8, 3-month follow up, 6-month follow up
Lipid panel
Time Frame: Baseline, Week 8, 3-month follow up, 6-month follow up
Standard of care Lipid panel
Baseline, Week 8, 3-month follow up, 6-month follow up
Comprehensive metabolic panel
Time Frame: Baseline, Week 8, 3-month follow up, 6-month follow up
Standard of care Comprehensive metabolic panel
Baseline, Week 8, 3-month follow up, 6-month follow up
Hemoglobin A1C
Time Frame: Baseline, Week 8, 3-month follow up, 6-month follow up
Standard of care Hemoglobin A1C
Baseline, Week 8, 3-month follow up, 6-month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Investigators

  • Principal Investigator: Amanda T. Sawyer, PhD, AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2023

Primary Completion (Actual)

November 1, 2025

Study Completion (Actual)

February 26, 2026

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2056943

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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