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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 belowSelect...
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 weeks3 visits
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)
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)
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.
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been recently diagnosed with stage I-III breast cancer and are planning to have surgery to remove the cancer.You had early stage breast cancer and received chemotherapy before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care (SOC)
- Group 2: Comprehensive Oncology Rehabilitation and Exercise (CORE) Program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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