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Exercise and Diet Counseling for Breast Cancer Survivors

N/A
Recruiting
Led By Brian C Focht, PhD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female breast cancer (stage I-III), within 60 months after cessation of active treatment (surgery, chemotherapy, radiation), and may be on continued hormone therapy.
Overweight/obese (body mass index [BMI] > 25).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Study Summary

This trial is testing whether an exercise and diet counseling program can help improve quality of life for overweight or obese breast cancer survivors.

Who is the study for?
This trial is for stage I-III breast cancer survivors who are overweight or obese (BMI > 25), within five years post-treatment, and may be on hormone therapy. Participants must be able to exercise, have their doctor's approval, and give informed consent. Those with conditions preventing safe exercise or active treatment for other cancers are excluded.Check my eligibility
What is being tested?
The study tests an exercise and diet counseling program aimed at improving the quality of life in breast cancer survivors by promoting weight loss. It includes aerobic and resistance training, nutritional advice, quality-of-life assessments, and questionnaires.See study design
What are the potential side effects?
While not drug-related, potential side effects from the interventions could include typical exercise risks such as muscle soreness or strain. Nutritional changes might also cause digestive adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Women who have had stage I-III breast cancer and have stopped treatment within the last 5 years, but may still be taking hormone therapy.
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You weigh more than what is considered healthy for your height.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mobility disability
Secondary outcome measures
Adherence assessment
Balance deficits assessment
Body composition
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive care (exercise program, counseling)Experimental Treatment6 Interventions
Patients undergo aerobic exercise over 10-30 minutes and resistance exercise comprising 1-3 sets of 8-12 repetitions of 10 different exercises over 1 hour for 24 weeks. Patients also receive behavioral activity counseling once a week and nutritional counseling over 30 minutes for 10 sessions after center-based exercise sessions during months 1-2.

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
316 Previous Clinical Trials
289,656 Total Patients Enrolled
22 Trials studying Breast Cancer
2,884 Patients Enrolled for Breast Cancer
Brian C Focht, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
3 Previous Clinical Trials
560 Total Patients Enrolled

Media Library

Exercise and Diet Counseling Program Clinical Trial Eligibility Overview. Trial Name: NCT04454086 — N/A
Breast Cancer Research Study Groups: Supportive care (exercise program, counseling)
Breast Cancer Clinical Trial 2023: Exercise and Diet Counseling Program Highlights & Side Effects. Trial Name: NCT04454086 — N/A
Exercise and Diet Counseling Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04454086 — N/A

Frequently Asked Questions

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

Who is eligible to enroll in this clinical research?

"This investigation is admitting 30 people with a BMI over 25 that range in age from thirty to seventy-five. The most pertinent criteria includes having female breast cancer (from stage one through three) within five years of ending active treatment, the readiness and physical capacity to take part in exercise programs, procurement of consent from both their primary care physician and oncologist, as well as understanding the conditions necessitating signing an informed permission form."

Answered by AI

Is there still availability for participants in this experiment?

"Current records on clinicaltrials.gov reveal that patient recruitment for this trial is ongoing and began in March 6th 2019, with the most recent update occurring June 3rd 2022."

Answered by AI

What is the recruitment quota for this research trial?

"Affirmative. According to clinicaltrials.gov, this medical exploration commenced on March 6th 2019 and has been updated as recent as June 3rd 2022; presently 30 participants are needed at one research facility."

Answered by AI

Is eligibility for this trial confined to individuals under 60 years of age?

"This medical trial requires that applicants are between 30 and 75 years old. There are 290 studies catering to those younger than 18 and 2912 for the elderly population."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
How old are they?
18 - 65
What site did they apply to?
Ohio State University Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
~5 spots leftby Mar 2025