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Cancer Rehab Program for Breast Cancer (CORE Trial)

N/A
Recruiting
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Newly diagnosed stage I-III breast cancer survivors who have plans to undergo breast cancer surgery
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upon completion of 24-weeks post-surgery soc visit for participants and about one year post-implementation (approximately 1 year into data collection)
Awards & highlights

CORE Trial Summary

This trial is testing a new cancer rehab program to see if it is feasible and acceptable. It also aims to see if it is better than the standard of care at getting people to exercise and improving physical function and quality of life.

Who is the study for?
This trial is for newly diagnosed breast cancer survivors with stage I-III who are planning to undergo surgery. It's not open to those who have already received neoadjuvant chemotherapy.Check my eligibility
What is being tested?
The study tests the CORE program, which aims to see if it's doable and well-received by patients, doctors, and clinic staff. It compares how this program versus standard care affects exercise engagement, physical function, and life quality in these patients.See study design
What are the potential side effects?
Since the intervention involves a rehabilitation and exercise program rather than medication, side effects may include muscle soreness or fatigue related to increased physical activity.

CORE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been recently diagnosed with stage I-III breast cancer and are planning to have surgery to remove the cancer.

CORE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon completion of 24-weeks post-surgery soc visit for participants and about one year post-implementation (approximately 1 year into data collection)
This trial's timeline: 3 weeks for screening, Varies for treatment, and upon completion of 24-weeks post-surgery soc visit for participants and about one year post-implementation (approximately 1 year into data collection) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants who complete in-clinic assessment
Percentage of participants who complete their referral
Secondary outcome measures
Change in exercise engagement assessed via accelerometer
Change in exercise engagement assessed via modified Godin survey
Percentage of themes identified from focus groups that contain positive feedback

CORE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Comprehensive Oncology Rehabilitation and Exercise (CORE) ProgramExperimental Treatment1 Intervention
Participants randomized to CORE will be instructed to follow the clinical algorithm for this study. An in-clinic assessment consisting of two questionnaires will be used to identify the appropriate pathway for triage. Participants will be triaged into one of three pathways: Physical Medicine & Rehabilitation, Personal Optimism With Exercise Recovery, or Exercise Self-Management.
Group II: Standard of Care (SOC)Active Control1 Intervention
Participants randomized to SOC will be instructed to continue their typical lifestyle activity.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,088 Previous Clinical Trials
1,728,277 Total Patients Enrolled
14 Trials studying Breast Cancer
7,052 Patients Enrolled for Breast Cancer

Media Library

Comprehensive Oncology Rehabilitation and Exercise (CORE) Program Clinical Trial Eligibility Overview. Trial Name: NCT04594473 — N/A
Breast Cancer Research Study Groups: Standard of Care (SOC), Comprehensive Oncology Rehabilitation and Exercise (CORE) Program
Breast Cancer Clinical Trial 2023: Comprehensive Oncology Rehabilitation and Exercise (CORE) Program Highlights & Side Effects. Trial Name: NCT04594473 — N/A
Comprehensive Oncology Rehabilitation and Exercise (CORE) Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04594473 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has recruitment for this trial begun yet?

"The available information from clinicaltrials.gov indicates that this trial is still open to participants, having been initially posted on March 24th 2021 and last updated on May 17th 2022."

Answered by AI

How many participants are being admitted to this research endeavor?

"Affirmative. The information on clinicaltrials.gov suggests that this trial, which was initially published on March 24th 2021, is still actively recruiting participants. 72 individuals need to be accepted from a single medical centre."

Answered by AI
~18 spots leftby Mar 2025