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Lifestyle Interventions for Cancer Survivors and High-Risk Individuals

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

Has experienced fatigue within the past seven days (PILOT III)

BRCA positive OR Lynch syndrome positive individuals (PILOT II)

Must not have

Unable to walk without crutches, walker, cane, or other assistive device

Currently receiving radiation therapy or cytotoxic chemotherapy (PILOTS II and III)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 4 months post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well different types of interventions work in motivating cancer survivors or high-risk family members to increase exercise and healthy food choices.

Who is the study for?

This trial is for breast cancer gene-positive, Lynch syndrome-positive individuals, CLL survivors or high-risk family members. Participants must be able to exercise moderately, read/write English, have internet access and a cell phone capable of texting. They should have a BMI of 25+ or low physical activity/fruit-vegetable intake.

What is being tested?

The study tests energy balance interventions like dietary changes, online programs, lab biomarker analysis, phone calls and questionnaires to see if they increase physical activity and healthy eating in participants at risk for cancer.

What are the potential side effects?

Since the interventions involve lifestyle modifications such as diet and exercise rather than medication, typical drug side effects are not expected. However, participants may experience muscle soreness or fatigue from increased physical activity.

Eligibility Criteria

Inclusion Criteria

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

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I have felt very tired in the last week.

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I am positive for BRCA mutation or Lynch syndrome.

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I am positive for BRCA mutation or Lynch syndrome.

Exclusion Criteria

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

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

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I am currently undergoing radiation therapy or chemotherapy.

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I am currently pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 4 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 4 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 months post-intervention for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in waist circumference (Pilot I)

Change in waist circumference (Pilot II)

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: Supportive care (energy balance interventions)Experimental Treatment5 Interventions

TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant responds) from a coach trained in motivational interviewing. TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and exercise recommendations daily 1-3 times per day or no text messages. SOCIAL NETWORKING: Participants are invited to an online forum for study participants available for 16 weeks or do not receive an invitation for social networking. SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1 day per week on a website or smartphone app.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary Intervention

2014

Completed Phase 2

~2550

Telephone-Based Intervention

2017

Completed Phase 2

~3400