Clinical trial NCT00548236: The Active After Cancer Trial (AACT)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer
Keywords: exercise intervention
AACT
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Cancer and Leukemia Group B
First posted: 2007-10-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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
* BMI \>47

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.
timeFrame: 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.
timeFrame: months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California at San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Concord
country: United States
facility: New Hampshire Oncology Hematology
state: New Hampshire
city: Hooksett
country: United States
facility: Lakes Regional Healthcare Hematology Oncology
state: New Hampshire
city: Buffalo
country: United States
facility: Rosewell Park Cancer Institute
state: New York
city: East Syracuse
country: United States
facility: Hematology Oncology Associates of Central New York
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Burlington
country: United States
facility: Vermont Cancer Center
state: Vermont
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Jennifer Ligibel, MD
role: PRINCIPAL_INVESTIGATOR
References: