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Exercise for Cognitive Impairment in Breast Cancer Survivors (ICAN Trial)
N/A
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months and baseline to 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will see if an exercise intervention can improve thinking skills in breast cancer survivors and help create exercise guidelines for them.
Who is the study for?
This trial is for breast cancer survivors who finished treatment at least 6 months ago but within the last 5 years, have low physical activity levels, own a Fitbit-compatible device with internet, and experience cognitive difficulties post-diagnosis. It's not for those with medical conditions that make unsupervised exercise unsafe or those unable to commit to a year-long study.
What is being tested?
The study is examining if an exercise program can boost brain function in breast cancer survivors. Participants will either engage in this physical activity intervention or be part of a control group without the special exercise regimen.
What are the potential side effects?
Since the intervention involves physical activity, potential side effects may include typical exercise-related issues such as muscle soreness, fatigue, or injury. However, these are generally mild and manageable.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6 months and baseline to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months and baseline to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test
Patient Reported Outcomes Measurement Information System (PROMIS) cognitive abilities
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise InterventionExperimental Treatment1 Intervention
This arm will receive a 12-month individually tailored phone and email-based exercise program.
Group II: Health & Wellness InterventionActive Control1 Intervention
This arm will receive a 12-month health and wellness program.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~820
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,803 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking tamoxifen or an aromatase inhibitor, and you plan to stop taking it within the next 6 months.You have trouble thinking clearly since you were diagnosed with cancer.You don't do much exercise.You have received chemotherapy or hormonal therapy for breast cancer.Women who finished treatment for breast cancer at least 6 months ago and were diagnosed with stage 1, 2, or 3 breast cancer within the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise Intervention
- Group 2: Health & Wellness 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.
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