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

Pilot Tests to Optimize the Delivery of Energy Balance Interventions

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fatigue; Overweight; Lynch Syndrome; Chronic Lymphocytic Leukemia; BRCA1 Gene Mutation; BRCA2 Gene Mutation; Breast Carcinoma; Cancer Survivor; Ovarian Carcinoma; Health Status Unknown; Body Mass Index 25 or Greater
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention; Dietary supplement: Dietary Intervention; Dietary supplement: Dietary Intervention; Other: Internet-Based Intervention; Other: Internet-Based Intervention; Behavioral: Telephone-Based Intervention

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. (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.

• Study Type: Interventional
• Enrollment (Actual): 337
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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.

Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies; Behavioral: Telephone-Based Intervention; Receive telephone coaching; 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; Behavioral: Telephone-Based Intervention; Receive text messages

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Karen M Basen-Engquist, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2014
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: July 16, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimated): July 18, 2014

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Skin Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Disease Attributes; Disease; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Breast Diseases; Overnutrition; Nutrition Disorders; Body Weight; Genetic Diseases, Inborn; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Neoplastic Syndromes, Hereditary; DNA Repair-Deficiency Disorders; Leukemia, Lymphoid; Leukemia; Leukemia, B-Cell; Chronic Disease; Syndrome; Breast Neoplasms; Carcinoma; Colorectal Neoplasms, Hereditary Nonpolyposis; Overweight; Leukemia, Lymphocytic, Chronic, B-Cell
• Other Study ID Numbers: 2014-0230 (Other Identifier: M D Anderson Cancer Center); NCI-2015-00095 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No