Status:

ACTIVE_NOT_RECRUITING

Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Body Mass Index 25 or Greater

BRCA1 Gene Mutation

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This pilot clinical trial studies different types of energy balance interventions to see how well they work in increasing the physical activity levels of breast cancer gene-positive patients, Lynch sy...

Detailed Description

PRIMARY OBJECTIVES: I. To explore the feasibility of using the multi-phase optimization strategy (MOST) approach to optimize energy balance (EB) interventions in a sample of MD Anderson employees. (P...

Eligibility Criteria

Inclusion

  • PILOTS I, II AND III: Body mass index (BMI) of 25 or higher OR \< 150 minutes of moderate to vigorous exercise per week OR \< 5 servings of fruit and vegetables per day
  • PILOTS I, II AND III: Capable of participating in moderate-vigorous unsupervised exercise
  • PILOTS I, II AND III: Have a cellular telephone and are able and willing to send and receive text messages
  • PILOTS I, II AND III: Able to read and write English
  • PILOTS I, II AND III: Have access to internet
  • PILOT II: BRCA positive OR Lynch syndrome positive individuals
  • PILOT II (FAMILY MEMBER): Female and male biological and non-biological family members of BRCA-positive individuals OR Lynch syndrome positive individuals
  • PILOT III: CLL survivors
  • PILOT III: Has experienced fatigue within the past seven days

Exclusion

  • PILOTS I, II AND III: Unable to walk without crutches, walker, cane, or other assistive device
  • PILOTS I, II AND III: Women who are pregnant (by self-report)
  • PILOTS I, II AND III: Less than 3 months post-surgery
  • PILOTS II and III: Currently receiving radiation therapy or cytotoxic chemotherapy

Key Trial Info

Start Date :

September 17 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 30 2027

Estimated Enrollment :

337 Patients enrolled

Trial Details

Trial ID

NCT02194387

Start Date

September 17 2014

End Date

September 30 2027

Last Update

September 8 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030