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Health Behavior Intervention for Cancer Risk Reduction in BRCA/Lynch Syndrome Families

N/A

Waitlist Available

Led By Karen M Basen-Engquist

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

HEALTH4CPC only: Female

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 months

Awards & highlights

Study Summary

This trial is testing a weight management and health behavior intervention to help those with hereditary breast and ovarian cancer and Lynch syndrome mutations lose or maintain a healthy weight and lower their risk of cancer.

Who is the study for?

This trial is for individuals with hereditary breast, ovarian cancer or Lynch syndrome who are overweight, inactive, eat less than 5 servings of fruits and veggies per day, and live near MD Anderson's main campus. It's not for pregnant/nursing women, those at high cancer risk, previous study participants, people undergoing certain cancer treatments or unable to walk unassisted.Check my eligibility

What is being tested?

The trial tests a weight management program that includes exercise routines, online resources via email and internet platforms, dietary guidance through behavioral interventions along with health education. Participants will also complete questionnaires and receive support over the phone.See study design

What are the potential side effects?

Since this is a lifestyle intervention focusing on diet and exercise rather than medication or surgery there may be minimal side effects such as muscle soreness from new physical activities or changes in digestion due to diet alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a female.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 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

Percent weight loss

Secondary outcome measures

Fruit and vegetable consumption

Percent energy from fat

Physical activity

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prevention (weight management, health behavior intervention)Experimental Treatment7 Interventions

Participants undergo weight management and health behavior intervention with a combination of 4 components for 16 weeks. TELEPHONE COACHING: Participants receive 1 phone call each week from a coach over 30-45 minutes to discuss diet, physical activity and goal setting. EMAIL COACHING: Participants receive 1 phone call to discuss the process over 10-15 minutes and then receive 1 email each week for 16 weeks. NO COACHING: Participants receive 1 phone call the first week over 10-15 minutes to discuss the process. TEXT MESSAGING: Participants receive 7-12 text messages comprising information about diet and physical activity each week for 16 weeks. SELF-MONITORING: Participants record their food intake and weight directly into the Fitbit website or application 4-7 days each week or 1 day each week for 16 weeks. FAMILY TEAM INTERVENTION: Participants receive 2 group phone calls and join a Facebook group that is monitored by research staff where they can interact with each other and coaches.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Intervention

2016

Completed Phase 4

~1330

Behavioral Dietary Intervention

2016

N/A

~70

Telephone-Based Intervention

2017

Completed Phase 2

~3400

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,283 Total Patients Enrolled

18 Trials studying Lynch Syndrome

52,682 Patients Enrolled for Lynch Syndrome

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,418 Total Patients Enrolled

5 Trials studying Lynch Syndrome

1,704 Patients Enrolled for Lynch Syndrome

Karen M Basen-EngquistPrincipal InvestigatorM.D. Anderson Cancer Center

4 Previous Clinical Trials

489 Total Patients Enrolled

1 Trials studying Lynch Syndrome

337 Patients Enrolled for Lynch Syndrome

Media Library

Health Promotion and Education Clinical Trial Eligibility Overview. Trial Name: NCT04125914 — N/A

Lynch Syndrome Research Study Groups: Prevention (weight management, health behavior intervention)

Lynch Syndrome Clinical Trial 2023: Health Promotion and Education Highlights & Side Effects. Trial Name: NCT04125914 — N/A

Health Promotion and Education 2023 Treatment Timeline for Medical Study. Trial Name: NCT04125914 — N/A

Frequently Asked Questions

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

Are individuals currently able to be enrolled in this research?

"Unfortunately, data from clinicaltrials.gov indicates that this study is no longer actively recruiting patients; the trial was first posted on January 26th 2017 and last updated April 7 2022. Fortunately, 5954 other trials remain open for recruitment at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Weight Management and Health Behavior Intervention in Lowering Cancer Risk for BRCA Positive and Lynch Syndrome Families

2017. "Weight Management and Health Behavior Intervention in Lowering Cancer Risk for BRCA Positive and Lynch Syndrome Families". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04125914.

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