Overview

This trial is active, not recruiting.

Conditions breast cancer, colorectal cancer
Treatment telephone-based exercise intervention
Sponsor Dana-Farber Cancer Institute
Collaborator Cancer and Leukemia Group B
Start date October 2007
End date March 2010
Trial size 120 participants
Trial identifier NCT00548236, 07-266

Summary

This study is being done to determine whether a telephone-based counseling intervention can help survivors of breast and colorectal cancer increase their weekly physical activity. Observational evidence suggests that physical activity after breast and colorectal cancer diagnosis decreases recurrence rates. Unfortunately, many people become less active during cancer therapy, and a substantial proportion never return to pre-diagnosis levels of physical activity. This study looks to see if people who have recently finished chemotherapy for breast, colon or rectal cancer can be motivated to increase their exercise by talking to an exercise specialist over the phone. The study also looks at changes in mood, fatigue, fitness, fat distribution and weight.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Immediate participation in a 16-week exercise program
telephone-based exercise intervention
Exercise counselling offered via telephone calls
(No Intervention)
Control population; will receive exercise plan after 16-week control period

Primary Outcomes

Measure
To evaluate the ability of a multi-center, telephone-based physical activity intervention to increase weekly physical activity levels in sedentary patients treated with adjuvant chemotherapy for Stage I-III breast or colorectal cancer.
time frame: months

Secondary Outcomes

Measure
To evaluate the impact of a physical activity intervention upon fitness, exercise self-efficacy, anthropometric measures, and quality of life in a group of patients with stage I-III breast or colorectal cancer.
time frame: months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically confirmed stage I-III breast or colorectal cancer - 18 years of age or older - Completed adjuvant treatment(for current malignancy) - Completion of all adjuvant chemotherapy and radiation (with the exception of adjuvant herceptin and/or tamoxifen/aromatase inhibitor therapy for breast cancer patients) between 2 and 36 months prior to enrollment - Ability to speak and read English - Willingness to be randomized - Medical clearance from an oncologist or primary care physician stating the participant is able to participate in an unsupervised, moderate-intensity physical activity program - No major surgery within 2 months of study enrollment or planned during study period Exclusion Criteria: - Metastatic cancer - Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements - Plans to have hip or knee replacement within a year - Participation in more than 60 minutes a week of moderate-intensity recreational activity as assessed by the International Physical Activity Questionnaire Short Form - BMI >47

Additional Information

Official title Pilot Study of a Multicenter, Telephone-Based Exercise Intervention for Patients With Early-Stage Breast and Colorectal Cancer: The Active After Cancer Trial (AACT)
Principal investigator Jennifer Ligibel, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.