The Active After Cancer Trial (AACT)

Breast Cancer Clinical 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00548236
• Other study ID #: 07-266
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2007
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Telephone-Based exercise intervention
Exercise counselling offered via telephone calls

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Rosewell Park Cancer Institute	Buffalo	New York
United States	Vermont Cancer Center	Burlington	Vermont
United States	Ohio State University	Columbus	Ohio
United States	New Hampshire Oncology Hematology	Concord	New Hampshire
United States	Hematology Oncology Associates of Central New York	East Syracuse	New York
United States	Lakes Regional Healthcare Hematology Oncology	Hooksett	New Hampshire
United States	University of California at San Diego	La Jolla	California
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Cancer and Leukemia Group B

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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