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Completed

NCT Number: NCT06078761

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AdventHealth

Orlando, Florida, 32804, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Healthy Eating Active Lifestyle (HEAL) Program

Behavioral

Evidence-based lifestyle medicine program for cancer survivors

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Weight

    Time frame: Baseline, Week 8, 3-month follow up, 6-month follow up

    Weight in kilograms

  8. Body Mass Index

    Time frame: Baseline, Week 8, 3-month follow up, 6-month follow up

    Body Mass Index (BMI)

  9. Blood pressure

    Time frame: Baseline, Week 8, 3-month follow up, 6-month follow up

    Blood pressure both systolic and diastolic

  10. Lipid panel

    Time frame: Baseline, Week 8, 3-month follow up, 6-month follow up

    Standard of care Lipid panel

  11. Comprehensive metabolic panel

    Time frame: Baseline, Week 8, 3-month follow up, 6-month follow up

    Standard of care Comprehensive metabolic panel

  12. Hemoglobin A1C

    Time frame: Baseline, Week 8, 3-month follow up, 6-month follow up

    Standard of care Hemoglobin A1C

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Official study title

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

Acronym: HEAL BC

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 12, 2023
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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