The Active After Cancer Trial (AACT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00548236
First received: October 22, 2007
Last updated: April 28, 2014
Last verified: April 2014
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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)

Resource links provided by NLM:


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: 120
Study Start Date: October 2007
Estimated Study Completion Date: July 2014
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Immediate participation in a 16-week exercise program
Behavioral: Telephone-Based exercise intervention
Exercise counselling offered via telephone calls
No Intervention: 2
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
University of California at San Diego
LA Jolla, California, United States, 92093
University of California San Francisco
San Francisco, California, United States, 94143
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New Hampshire
New Hampshire Oncology Hematology
Concord, New Hampshire, United States, 03106
Lakes Regional Healthcare Hematology Oncology
Hooksett, New Hampshire, United States, 03106
United States, New York
Rosewell Park Cancer Institute
Buffalo, New York, United States, 14263
Hematology Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Vermont
Vermont Cancer Center
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Dana-Farber Cancer Institute
Cancer and Leukemia Group B
Investigators
Principal Investigator: Jennifer Ligibel, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Jennifer A. Ligibel, MD, Assistant Professor, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00548236     History of Changes
Other Study ID Numbers: 07-266
Study First Received: October 22, 2007
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
exercise intervention
AACT

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 22, 2014