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Behavioral Intervention
Nutrition and Physical Activity Counseling for Breast Cancer
N/A
Recruiting
Led By Elizabeth Stone, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Performance status 0 or 1 as per ECOG scale [see Appendix IV]
Breast cancer diagnosis (stage 0-III)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months and 6 months
Awards & highlights
Study Summary
This trial is testing a new way to help breast cancer survivors who are overweight lose weight, by counseling them over the phone and in person.
Who is the study for?
This trial is for breast cancer survivors with a BMI of 25 or higher, at stages 0-III. They must understand and agree to the study's terms, be in good health as per ECOG scale (0 or 1), and be under care at Maroone Cancer Center. Participants should be able to attend nutrition counseling there and do exercise testing if cleared by their oncologist.Check my eligibility
What is being tested?
The study tests an individualized program combining in-person and phone-based advice on diet and exercise tailored for overweight breast cancer survivors. It aims to see if this approach helps them lose weight without needing frequent travel for sessions.See study design
What are the potential side effects?
Since the intervention involves nutrition and physical activity counseling rather than medication, side effects are minimal but may include muscle soreness from new exercises or changes in digestion due to diet adjustments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have been diagnosed with breast cancer at stage 0 to III.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compliance to physical activity goal
Compliance to the recommended dietary pattern
Percent of participants achieving 10% weight loss
Secondary outcome measures
Body fat percentage
Cholesterol
Glycemic control as measured by HbA1c
+6 moreOther outcome measures
Factors associated with adherence to the program
Quality of life as measured by Brief Pain Inventory (BPI)
Quality of life as measured by Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Individualized, nutrition and physical activity interventionExperimental Treatment1 Intervention
Initial in-person consult with a registered dietitian, with further in-person follow-ups and monthly telephone consults
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Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,850 Total Patients Enrolled
54 Trials studying Breast Cancer
4,907 Patients Enrolled for Breast Cancer
Elizabeth Stone, MDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never had breast cancer before.I am fully active or restricted in physically strenuous activity but can do light work.My cancer has spread to other parts of my body.I am not on chemotherapy, immunotherapy, or radiation but may be on hormonal therapy.I have been diagnosed with breast cancer at stage 0 to III.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am willing to attend nutrition counseling at Maroone Cancer Center.I cannot or do not want to attend nutrition counseling at Maroone Cancer Center.
Research Study Groups:
This trial has the following groups:- Group 1: Individualized, nutrition and physical activity intervention
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.
What are the principal aims of this investigation?
"This clinical trial, monitored over a span of 6 months, intends to assess adherence to the prescribed diet. Secondary endpoints include C-Reactive Protein (CRP) levels and cholesterol concentrations in order to measure the impact of this intervention on lipid profile as well Maximum oxygen uptake as determined by VO2 max readings."
Answered by AI
How many participants are included in this clinical trial?
"Indeed, clinicaltrials.gov indicates that this research venture is actively recruiting participants. It was initially posted on June 1st 2021 and the most recent update took place on June 6th 2022; 60 patients are being sought after to participate in this trial at a single site."
Answered by AI
Is the enrollment period for this clinical trial still open?
"On clinicaltrials.gov, this medical trial is listed as actively recruiting patients for participation. The profile was created on the 6th of January 2021 and updated most recently on the 6th of June 2022."
Answered by AI
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