The Active After Cancer Trial (AACT) (AACT)

January 22, 2024 updated by: Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California at San Diego
      • San Francisco, California, United States, 94143
        • University of California San Francisco
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
    • New Hampshire
      • Concord, New Hampshire, United States, 03106
        • New Hampshire Oncology Hematology
      • Hooksett, New Hampshire, United States, 03106
        • Lakes Regional Healthcare Hematology Oncology
    • New York
      • Buffalo, New York, United States, 14263
        • Rosewell Park Cancer Institute
      • East Syracuse, New York, United States, 13057
        • Hematology Oncology Associates of Central New York
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Vermont Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: months
months

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: months
months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Cancer and Leukemia Group B

Investigators

  • Principal Investigator: Jennifer Ligibel, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 22, 2007

First Submitted That Met QC Criteria

October 22, 2007

First Posted (Estimated)

October 23, 2007

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-266

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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