The Active After Cancer Trial (AACT)

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of a Multicenter, Telephone-Based Exercise Intervention for Patients With Early-Stage Breast and Colorectal Cancer: The Active After Cancer Trial (AACT)

Conditions
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Breast Cancer, Colorectal Cancer

Intervention / Treatment
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* Behavioral: Telephone-Based exercise intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Immediate participation in a 16-week exercise program | Behavioral: Telephone-Based exercise intervention<br>* Exercise counselling offered via telephone calls<br>|
| No Intervention: 2<br>Control population; will receive exercise plan after 16-week control period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise intervention, AACT