Clinical trial

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 · Not applicable · 1 countries · Registry ID NCT02194387

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionBody 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

Full registry 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

Treatments and study arms

Dietary Intervention

Dietary Supplement

Record dietary intake 4-7 days per week

Dietary Intervention

Dietary Supplement

Record dietary intake 1 day per week

Internet-Based Intervention

Other

Receive email coaching

Internet-Based Intervention

Other

Participate in social networking

Laboratory Biomarker Analysis

Other

Correlative studies

Questionnaire Administration

Other

Ancillary studies

Telephone-Based Intervention

Behavioral

Receive telephone coaching

Telephone-Based Intervention

Behavioral

Receive text messages

Primary outcomes

Change in waist circumference (Pilot I)Baseline to 4 months post-intervention

Expressed as the mean difference.

Change in waist circumference (Pilot II)Baseline to 4 months post-intervention

Expressed as the mean difference.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

M D Anderson Cancer Center🇺🇸 Houston, Texas, United States

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