Trials / Active Not Recruiting

Active Not RecruitingNCT02194387

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

Status: Active Not Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 337 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Accepted

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.

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.

Conditions

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary Intervention	Record dietary intake 4-7 days per week
DIETARY_SUPPLEMENT	Dietary Intervention	Record dietary intake 1 day per week
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

Timeline

Start date: 2014-09-17
Primary completion: 2027-09-30
Completion: 2027-09-30
First posted: 2014-07-18
Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT02194387. Inclusion in this directory is not an endorsement.