The Active After Cancer Trial (AACT)
This study is ongoing, but not recruiting participants.
Sponsor:
Dana-Farber Cancer Institute
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: July 24, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Breast Cancer Colorectal Cancer |
Behavioral: Telephone-Based exercise intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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) |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
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. [ Time Frame: months ] [ Designated as safety issue: No ]
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. [ Time Frame: months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | September 2012 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548236
Locations
| United States, California | |
| University of California at San Diego | |
| LA Jolla, California, United States, 92093 | |
| University of California San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New Hampshire | |
| New Hampshire Oncology Hematology | |
| Concord, New Hampshire, United States, 03106 | |
| Lakes Regional Healthcare Hematology Oncology | |
| Hooksett, New Hampshire, United States, 03106 | |
| United States, New York | |
| Rosewell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| Hematology Oncology Associates of Central New York | |
| East Syracuse, New York, United States, 13057 | |
| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Vermont | |
| 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 |
More Information
No publications provided
| Responsible Party: | Jennifer A. Ligibel, MD, Assistant Professor, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00548236 History of Changes |
| Other Study ID Numbers: | 07-266 |
| Study First Received: | October 22, 2007 |
| Last Updated: | July 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
exercise intervention AACT |
Additional relevant MeSH terms:
|
Breast Neoplasms Colorectal Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Intestinal Neoplasms |
Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on June 17, 2013