The Active After Cancer Trial (AACT)

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00548236

Collaborator

Cancer and Leukemia Group B (Other)

120

Enrollment

Locations

Arms

182

Anticipated Duration (Months)

13.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Colorectal Cancer	Behavioral: Telephone-Based exercise intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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)

Actual Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Mar 1, 2009

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

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. [months]

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. [months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of California at San Diego	La Jolla	California	United States	92093
2	University of California San Francisco	San Francisco	California	United States	94143
3	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
4	New Hampshire Oncology Hematology	Concord	New Hampshire	United States	03106
5	Lakes Regional Healthcare Hematology Oncology	Hooksett	New Hampshire	United States	03106
6	Rosewell Park Cancer Institute	Buffalo	New York	United States	14263
7	Hematology Oncology Associates of Central New York	East Syracuse	New York	United States	13057
8	Ohio State University	Columbus	Ohio	United States	43210
9	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jennifer A. Ligibel, MD, Assistant Professor, Dana-Farber Cancer Institute

ClinicalTrials.gov Identifier:

NCT00548236

Other Study ID Numbers:

07-266

First Posted:

Oct 23, 2007

Last Update Posted:

Jan 6, 2022

Last Verified:

Jan 1, 2022

Keywords provided by Jennifer A. Ligibel, MD, Assistant Professor, Dana-Farber Cancer Institute

exercise intervention

AACT

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Jan 6, 2022