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

October 22, 2007
April 28, 2014
October 2007
March 2010   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00548236 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
 
The Active After Cancer Trial (AACT)
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Cancer
  • Colorectal Cancer
Behavioral: Telephone-Based exercise intervention
Exercise counselling offered via telephone calls
  • Experimental: 1
    Immediate participation in a 16-week exercise program
    Intervention: Behavioral: Telephone-Based exercise intervention
  • No Intervention: 2
    Control population; will receive exercise plan after 16-week control period
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
July 2014
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00548236
07-266
Yes
Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Cancer and Leukemia Group B
Principal Investigator: Jennifer Ligibel, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP