Clinical trial NCT02194387: Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
Official title: Pilot Tests to Optimize the Delivery of Energy Balance Interventions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-07-18
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in waist circumference (Pilot I)
timeFrame: Baseline to 4 months post-intervention
measure: Change in waist circumference (Pilot II)
timeFrame: Baseline to 4 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Karen M Basen-Engquist
role: PRINCIPAL_INVESTIGATOR
References: