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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Tests to Optimize the Delivery of Energy Balance Interventions

Conditions
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Body Mass Index 25 or Greater, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Breast Carcinoma, Cancer Survivor, Chronic Lymphocytic Leukemia, Fatigue, Health Status Unknown, Lynch Syndrome, Ovarian Carcinoma, Overweight

Intervention / Treatment
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* Dietary Supplement: Dietary Intervention
* Dietary Supplement: Dietary Intervention
* Other: Internet-Based Intervention
* Other: Internet-Based Intervention
* Other: Laboratory Biomarker Analysis
* Other: Questionnaire Administration
* Behavioral: Telephone-Based Intervention
* Behavioral: Telephone-Based Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (energy balance interventions)<br>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. | Dietary Supplement: Dietary Intervention<br>* Record dietary intake 4-7 days per week<br>* Other names: Nutritional Interventions;Dietary Supplement: Dietary Intervention<br>* Record dietary intake 1 day per week<br>* Other names: Nutritional Interventions;Other: Internet-Based Intervention<br>* Receive email coaching<br>Other: Internet-Based Intervention<br>* Participate in social networking<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Behavioral: Telephone-Based Intervention<br>* Receive telephone coaching<br>Behavioral: Telephone-Based Intervention<br>* Receive text messages<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in waist circumference (Pilot I) | Expressed as the mean difference. | Baseline to 4 months post-intervention | 
| Change in waist circumference (Pilot II) | Expressed as the mean difference. | Baseline to 4 months post-intervention |