The Active After Cancer Trial (AACT)

NCT ID: NCT00548236

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Immediate participation in a 16-week exercise program

Group Type EXPERIMENTAL

Telephone-Based exercise intervention

Intervention Type BEHAVIORAL

Exercise counselling offered via telephone calls

2

Control population; will receive exercise plan after 16-week control period

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telephone-Based exercise intervention

Exercise counselling offered via telephone calls

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer and Leukemia Group B

NETWORK

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Jennifer A. Ligibel, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Ligibel, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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University of California at San Diego

La Jolla, California, United States

Site Status

University of California San Francisco

San Francisco, California, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

New Hampshire Oncology Hematology

Concord, New Hampshire, United States

Site Status

Lakes Regional Healthcare Hematology Oncology

Hooksett, New Hampshire, United States

Site Status

Rosewell Park Cancer Institute

Buffalo, New York, United States

Site Status

Hematology Oncology Associates of Central New York

East Syracuse, New York, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Vermont Cancer Center

Burlington, Vermont, United States

Site Status

Countries

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United States

Other Identifiers

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07-266

Identifier Type: -

Identifier Source: org_study_id

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