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

Overweight Clinical Trial

Official title: Pilot Tests to Optimize the Delivery of Energy Balance Interventions

Status Active, not recruiting

Clinical Trial 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 syndrome-positive patients, chronic lymphocytic leukemia (CLL) survivors or family members of cancer survivors who are at high risk for cancer. Increasing exercise and eating healthy foods may help reduce the risk of cancer. Studying how well different types of interventions work in motivating cancer survivors or high-risk family members to increase exercise and healthy food choices may help doctors plan the most effective motivational program for cancer prevention.

Clinical Trial 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. (Pilot I) II. To explore the feasibility of using the MOST approach to optimize energy balance interventions in a sample of BRCA (BReast CAncer)-positive and Lynch syndrome positive individuals and their family members. (Pilot II) III. To explore the feasibility of using the MOST approach to optimize energy balance interventions in a sample of CLL (chronic lymphocytic leukemia) patients. (Pilot III)

SECONDARY OBJECTIVES:

I. To develop preliminary estimates of effect size and outcome variability for use in planning future studies. (Pilot I) II. To develop preliminary estimates of effect size and outcome variability for use in planning future studies. (Pilot II) III. To develop preliminary estimates of effect size and outcome variability for use in planning future studies. (Pilot III)

EXPLORATORY OBJECTIVES:

I. To examine relationship between individual-level (e.g., distress) and family-level (e.g., shared mutation status) variables that are specific to high-risk families and the effectiveness of energy balance interventions. (Pilot II)

OUTLINE: Participants are assigned to 1 condition in each component for a total of 16 groups using a randomized factorial design.

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 application (app).

After completion of study, patients are followed up at 4 months. ;

Related Conditions & MeSH terms

• Body Mass Index 25 or Greater
• BRCA1 Gene Mutation
• BRCA2 Gene Mutation
• Breast Carcinoma
• Breast Neoplasms
• Cancer Survivor
• Carcinoma
• Chronic Lymphocytic Leukemia
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Fatigue
• Health Status Unknown
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lynch Syndrome
• Ovarian Carcinoma
• Overweight
• Syndrome

• NCT number: NCT02194387
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 17, 2014
• Completion date: September 30, 2025