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Mobile-Health Lifestyle Interventions for Breast Cancer

N/A
Recruiting
Led By Lorenzo Cohen
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 months after study baseline
Awards & highlights

Study Summary

This trial is developing a lifestyle program to improve outcomes in women with breast cancer who don't have healthy diets, regular exercise, or ways to manage stress. The program will include support and counseling in healthy eating, physical activity, stress management and mindfulness, sleep hygiene, and behavioral counseling.

Who is the study for?
This trial is for women over 18 with stage I-III breast cancer who've finished chemotherapy and surgery. They should have a BMI of 25 or higher, engage in little physical activity, eat less than three servings of fruits and vegetables daily, and not practice stress management often. Participants must be able to read English, use the internet, perform light exercise (with medical clearance if needed), and visit certain locations for blood collection.Check my eligibility
What is being tested?
The study tests a lifestyle program designed to improve diet, increase physical activity using FitBit trackers, teach stress management through mindfulness practices, enhance sleep hygiene techniques, provide behavioral counseling and social support. The goal is to see if this program can boost quality of life for breast cancer survivors.See study design
What are the potential side effects?
Since this trial focuses on lifestyle changes rather than medication or invasive procedures, side effects are minimal but may include muscle soreness from new physical activities or emotional discomfort during counseling sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 months after study baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 months after study baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess the feasibility of delivering a mobile, standardized, comprehensive lifestyle program in women with BCa.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GROUP I (CLIP)Experimental Treatment5 Interventions
Patients undergo 60 minute sessions of nutrition education for 12 weeks and behavioral intervention 26 weeks. Patients receive FitBit and undergo physical activity for 30-60 minutes 5 days a week (aerobic activity) and 2 days a week (resistance training).
Group II: GROUP II (usual care)Active Control2 Interventions
Patients have access to all usual care supportive services.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Intervention
2021
Completed Phase 4
~3740
FitBit
2017
N/A
~480
Nutrition Education
2018
Completed Phase 3
~7750

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,287 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,260 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Lorenzo CohenPrincipal InvestigatorM.D. Anderson Cancer Center
11 Previous Clinical Trials
58,264 Total Patients Enrolled
1 Trials studying Breast Cancer
452 Patients Enrolled for Breast Cancer

Media Library

Behavioral Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05132296 — N/A
Breast Cancer Research Study Groups: GROUP I (CLIP), GROUP II (usual care)
Breast Cancer Clinical Trial 2023: Behavioral Intervention Highlights & Side Effects. Trial Name: NCT05132296 — N/A
Behavioral Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05132296 — N/A

Frequently Asked Questions

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

What is the approximate number of participants being recruited for this research?

"Indeed, details posted on clinicaltrials.gov confirms that the study is still in search of applicants and commenced recruitment on May 21st 2021. The last update to this trial was made April 21st 2022 with 30 participants sought from a single site."

Answered by AI

Are there any openings available for participants in this experiment?

"Affirmative. According to information on clinicaltrials.gov, this medical study is currently taking part in the recruitment process which started on May 21st 2021 and was recently updated on April 21 2022. 30 participants are required at one site for successful completion of the trial."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Mobile-Health Delivery of Lifestyle Interventions for Women With Breast Cancer
2021. "Mobile-Health Delivery of Lifestyle Interventions for Women With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05132296.
~15 spots leftby Feb 2027
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