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Clinical Trial NCT02194387 for 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 is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members

Active, not recruiting
Clinical Trial NCT02194387 is an interventional study for 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 that is active, not recruiting. It started on 17 September 2014 with plans to enroll 337 participants. Led by M.D. Anderson Cancer Center, it is expected to complete by 30 September 2027. The latest data from ClinicalTrials.gov was last updated on 8 September 2025.
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.
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.

Official Title

Pilot Tests to Optimize the Delivery of Energy Balance Interventions

Conditions
Body Mass Index 25 or GreaterBRCA1 Gene MutationBRCA2 Gene MutationBreast CarcinomaCancer SurvivorChronic Lymphocytic LeukemiaFatigueHealth Status UnknownLYNCH SyndromeOvarian CarcinomaOverweight
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
NCT ID Number
NCT02194387
Start Date (Actual)
2014-09-17
Last Update Posted
2025-09-08
Completion Date (Estimated)
2027-09-30
Enrollment (Estimated)
337
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSupportive 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 Intervention
Record dietary intake 4-7 days per week
Dietary Intervention
Record dietary intake 1 day per week
Internet-based Intervention
Receive email coaching
Internet-based Intervention
Participate in social networking
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Telephone-based Intervention
Receive telephone coaching
Telephone-based Intervention
Receive text messages
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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

  • 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
M.D. Anderson Cancer Center logoM.D. Anderson Cancer Center1128 active trials to explore
National Cancer Institute (NCI) logoNational Cancer Institute (NCI)3028 active trials to explore
No contact data.
1 Study Locations in 1 Countries

Texas

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