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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 months post-intervention
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have felt very tired in the last week.
Select...
I am positive for BRCA mutation or Lynch syndrome.
Select...
I am positive for BRCA mutation or Lynch syndrome.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in waist circumference (Pilot I)
Change in waist circumference (Pilot II)

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

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,465 Total Patients Enrolled
10 Trials studying Obesity
2,518 Patients Enrolled for Obesity
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,330 Total Patients Enrolled
49 Trials studying Obesity
31,488 Patients Enrolled for Obesity
Karen M Basen-EngquistPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
536 Total Patients Enrolled
1 Trials studying Obesity
51 Patients Enrolled for Obesity

Media Library

Dietary Intervention Clinical Trial Eligibility Overview. Trial Name: NCT02194387 — N/A
Obesity Research Study Groups: Supportive care (energy balance interventions)
Obesity Clinical Trial 2023: Dietary Intervention Highlights & Side Effects. Trial Name: NCT02194387 — N/A
Dietary Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT02194387 — N/A

Frequently Asked Questions

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

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
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
2014. "Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02194387.
All > Overweight
~43 spots leftby Sep 2025
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