To hear about similar clinical trials, please enter your email below
Trial Title:
Healthy Eating and Active Lifestyle (HEAL): Breast Cancer Program Outcomes
NCT ID:
NCT06078761
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
Healthy Eating Active Lifestyle (HEAL) Program
Description:
Evidence-based lifestyle medicine program for cancer survivors
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.
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.
Criteria for eligibility:
Study pop:
Breast cancer survivors recruited from the AdventHealth Medical Group that were referred
to attend the Healthy Eating and Active Lifestyle Breast Cancer Program.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AdventHealth
Address:
City:
Orlando
Zip:
32804
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amanda Sawyer, PhD
Email:
amanda.sawyer@adventhealth.com
Contact backup:
Last name:
Tere Richard, MHSA
Email:
tere.richard@adventhealth.com
Investigator:
Last name:
Amanda Sawyer, PhD
Email:
Principal Investigator
Start date:
September 21, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
AdventHealth
Agency class:
Other
Source:
AdventHealth
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06078761
