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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02194387
• Other study ID #: 2014-0230
• Secondary ID: NCI-2015-0009520
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 17, 2014
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 337
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Dietary Supplement:
• Dietary Intervention
Record dietary intake 4-7 days per week
• Dietary Intervention
Record dietary intake 1 day per week

Other:
• Internet-Based Intervention
Receive email coaching
• Internet-Based Intervention
Participate in social networking
• Laboratory Biomarker Analysis
Correlative studies
• Questionnaire Administration
Ancillary studies

Behavioral:
• Telephone-Based Intervention
Receive telephone coaching
• Telephone-Based Intervention
Receive text messages

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in waist circumference (Pilot I)	Expressed as the mean difference.	Baseline to 4 months post-intervention
Primary	Change in waist circumference (Pilot II)	Expressed as the mean difference.	Baseline to 4 months post-intervention

External Links

•   M D Anderson Cancer Center