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The Active After Cancer Trial (AACT) (AACT)

Primary Purpose

Breast Cancer, Colorectal Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone-Based exercise intervention
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring exercise intervention, AACT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of California at San Diego
  • University of California San Francisco
  • Dana-Farber Cancer Institute
  • New Hampshire Oncology Hematology
  • Lakes Regional Healthcare Hematology Oncology
  • Rosewell Park Cancer Institute
  • Hematology Oncology Associates of Central New York
  • Ohio State University
  • Vermont Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Immediate participation in a 16-week exercise program

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

Outcomes

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.

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.

Full Information

First Posted
October 22, 2007
Last Updated
February 6, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Cancer and Leukemia Group B
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1. Study Identification

Unique Protocol Identification Number
NCT00548236
Brief Title
The Active After Cancer Trial (AACT)
Acronym
AACT
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2007 (Actual)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Cancer and Leukemia Group B

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer
Keywords
exercise intervention, AACT

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Immediate participation in a 16-week exercise program
Arm Title
2
Arm Type
No Intervention
Arm Description
Control population; will receive exercise plan after 16-week control period
Intervention Type
Behavioral
Intervention Name(s)
Telephone-Based exercise intervention
Intervention Description
Exercise counselling offered via telephone calls
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Ligibel, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
New Hampshire Oncology Hematology
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03106
Country
United States
Facility Name
Lakes Regional Healthcare Hematology Oncology
City
Hooksett
State/Province
New Hampshire
ZIP/Postal Code
03106
Country
United States
Facility Name
Rosewell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Hematology Oncology Associates of Central New York
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Vermont Cancer Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

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The Active After Cancer Trial (AACT)

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