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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02194387

Collaborator

National Cancer Institute (NCI) (NIH)

337

Enrollment

Location

Arm

96.4

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
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	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	N/A

Detailed Description

PRIMARY OBJECTIVES:

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)
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:

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:

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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

337 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Pilot Tests to Optimize the Delivery of Energy Balance Interventions

Actual Study Start Date :

Sep 17, 2014

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Supportive care (energy balance 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.	Dietary Supplement: Dietary Intervention Record dietary intake 4-7 days per week Other Names: Dietary Modification intervention, dietary Nutrition Intervention Nutrition Interventions Nutritional Interventions Dietary Supplement: Dietary Intervention Record dietary intake 1 day per week Other Names: Dietary Modification intervention, dietary Nutrition Intervention Nutrition Interventions Nutritional Interventions Other: Internet-Based Intervention Receive email coaching Other: Internet-Based Intervention Participate in social networking Other: Laboratory Biomarker Analysis Correlative studies Other: Questionnaire Administration Ancillary studies Behavioral: Telephone-Based Intervention Receive telephone coaching Behavioral: Telephone-Based Intervention Receive text messages

Arm

Intervention/Treatment

Experimental: Supportive care (energy balance 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.

Dietary Supplement: Dietary Intervention

Record dietary intake 4-7 days per week

Other Names:

Dietary Modification

intervention, dietary

Nutrition Intervention

Nutrition Interventions

Nutritional Interventions

Dietary Supplement: Dietary Intervention

Record dietary intake 1 day per week

Other Names:

Dietary Modification

intervention, dietary

Nutrition Intervention

Nutrition Interventions

Nutritional Interventions

Other: Internet-Based Intervention

Receive email coaching

Other: Internet-Based Intervention

Participate in social networking

Other: Laboratory Biomarker Analysis

Correlative studies

Other: Questionnaire Administration

Ancillary studies

Behavioral: Telephone-Based Intervention

Receive telephone coaching

Behavioral: Telephone-Based Intervention

Receive text messages

Outcome Measures

Primary Outcome Measures

Change in waist circumference (Pilot I) [Baseline to 4 months post-intervention]
Expressed as the mean difference.
Change in waist circumference (Pilot II) [Baseline to 4 months post-intervention]
Expressed as the mean difference.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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