The Active After Cancer Trial (AACT) - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Cancer and Leukemia Group B
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00548236

Purpose

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.

Condition	Intervention
Breast Cancer Colorectal Cancer	Behavioral: Telephone-Based exercise intervention

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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)

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Immediate participation in a 16-week exercise program	Behavioral: Telephone-Based exercise intervention Exercise counselling offered via telephone calls
2: No Intervention Control population; will receive exercise plan after 16-week control period

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed stage I-III breast or colorectal cancer
18 years of age or older
Received treatment with adjuvant or neoadjuvant chemotherapy (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 12 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 >40

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548236

Contacts

Contact: Jennifer Ligibel, MD

617-632-5961

jligibel@partners.org

Locations

United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Cancer and Leukemia Group B

Investigators

Principal Investigator:

Jennifer Ligibel, MD

Dana-Farber Cancer Institute

More Information

Responsible Party:	Dana-Farber Cancer Institute ( Jennifer Ligibel, MD )
Study ID Numbers:	07-266
Study First Received:	October 22, 2007
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00548236
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

exercise intervention
AACT

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Skin Diseases
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms

Breast Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Breast Diseases
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009