Pilot Study of a Multicenter, Telephone-Based Exercise Intervention for Patients With Early-Stage Breast and Colorectal Cancer: The Active After Cancer Trial (AACT)
Overview
- Phase
- N/A
- Intervention
- Telephone-Based exercise intervention
- Conditions
- Breast Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 120
- Locations
- 9
- Primary Endpoint
- 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.
- Status
- Active, Not Recruiting
- Last Updated
- 2 months ago
Overview
Brief 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.
Investigators
Jennifer A. Ligibel, MD
Assistant Professor
Dana-Farber Cancer Institute
Eligibility Criteria
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
Arms & Interventions
1
Immediate participation in a 16-week exercise program
Intervention: Telephone-Based exercise intervention
2
Control population; will receive exercise plan after 16-week control period
Outcomes
Primary Outcomes
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
- 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.(months)