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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

Must not have

HEALTH4CPC only: Persons diagnosed with any invasive cancer excluding non-melanoma skin cancer

Within 3 months of major surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 months

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I am a female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with cancer, excluding non-melanoma skin cancer.

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I had major surgery less than 3 months ago.

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I am not pregnant or nursing.

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I am currently undergoing radiation or chemotherapy.

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I need help from devices like crutches or a walker to walk.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent weight loss

Secondary study objectives

Fruit and vegetable consumption

Percent energy from fat

Physical activity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Completed Phase 1

~130