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Behavioral Intervention
Supportive Care (Fitbit) for Breast Cancer
N/A
Recruiting
Led By Cindy K Blair, Ph.D.
Research Sponsored by New Mexico Cancer Care Alliance
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Any breast surgery (lumpectomy or mastectomy)
PBSPS defined as pain in the area of breast surgery of at least moderate intensity (>= 4 on a scale of 1-10), located in the ipsilateral beast/chest wall, axilla or arm, lasting at least 6 months, and occurring at least 50% of the time
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial aims to find out if being more active throughout the day can help improve chronic pain and other symptoms in breast cancer survivors after surgery. Being physically active is important for overall health and may help reduce
Who is the study for?
This trial is for young, Hispanic women who have survived breast cancer and are experiencing chronic pain post-surgery. Participants should be interested in increasing their daily physical activity to potentially improve their pain and overall well-being.Check my eligibility
What is being tested?
The study is testing if using a Fitbit to track daily activity, along with health coaching, can help reduce chronic pain in participants. It aims to understand the impact of increased physical activity on survivors' mental and social health too.See study design
What are the potential side effects?
There may not be direct side effects from using a Fitbit or participating in this type of intervention. However, increasing physical activity could lead to muscle soreness or fatigue initially.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had breast surgery.
Select...
I have pain in the surgery area of my breast/chest, arm, or axilla that's moderate or worse, lasting over 6 months and happens most of the time.
Select...
I am between 18 and 60 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence rate (Feasibility)
Incidence of adverse events
Recruitment rate (Feasibility)
+1 moreSecondary outcome measures
Change in chronic post-surgical pain
Change in health-related quality of life (hrQOL)
Change in physical activity
Trial Design
1Treatment groups
Experimental Treatment
Group I: Supportive Care (Fitbit)Experimental Treatment1 Intervention
Patients wear a Fitbit and use the Fitbit application to monitor their physical activity daily in weeks 2-12 with the goal of increasing their number of steps per day and their number of active hours per day. Starting at week 2, patients also receive educational materials and attend 6 calls over 20-60 minutes each with their health coach in weeks 2, 3, 5, 7, 9, and 11.
Find a Location
Who is running the clinical trial?
New Mexico Cancer Care AllianceLead Sponsor
70 Previous Clinical Trials
52,442 Total Patients Enrolled
4 Trials studying Breast Cancer
770 Patients Enrolled for Breast Cancer
University of New MexicoOTHER
372 Previous Clinical Trials
3,528,764 Total Patients Enrolled
6 Trials studying Breast Cancer
2,346,634 Patients Enrolled for Breast Cancer
Cindy K Blair, Ph.D.Principal InvestigatorNew Mexico Cancer Care Alliance
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies for potential participants in this research study?
"According to information available on clinicaltrials.gov, this research trial is presently in the recruitment phase. The initial posting date for this study was October 20th, 2023, with the most recent update occurring on February 6th, 2024."
Answered by AI
Is the clinical trial accepting participants who are below 45 years of age?
"Individuals aged above 18 and under 60 are eligible to participate in this research."
Answered by AI
How many individuals are anticipated to participate in this research?
"Indeed, data from clinicaltrials.gov confirms that this research is actively seeking participants. This trial was first listed on October 20th, 2023 and its most recent update was on February 6th, 2024. The study aims to enroll a total of 25 patients at one designated site."
Answered by AI
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