Rehabilitation of Cognitive Changes in Breast Cancer Survivors
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ClinicalTrials.gov Identifier: NCT01182506 |
Recruitment Status
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Active, not recruiting
First Posted
: August 16, 2010
Last Update Posted
: September 6, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | August 12, 2010 | |||
First Posted Date ICMJE | August 16, 2010 | |||
Last Update Posted Date | September 6, 2017 | |||
Study Start Date ICMJE | August 2010 | |||
Estimated Primary Completion Date | August 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Determine the efficacy of working memory training [ Time Frame: 2 years ] in breast cancer survivors based on improved performance on neuropsychological tests of working memory.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01182506 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Rehabilitation of Cognitive Changes in Breast Cancer Survivors | |||
Official Title ICMJE | Rehabilitation of Cognitive Changes in Breast Cancer Survivors | |||
Brief Summary | The purpose of this study is to test a memory training program for breast cancer survivors who have problems with memory after receiving chemotherapy. Since breast cancer survivors have been reported to have trouble with their memory, a program to help these problems is important. Studies have shown that a 5-week software training program improved memory in pediatric cancer survivors and other disorders like stroke, but it has not been tested for breast cancer survivors. This study will see if breast cancer survivors can improve their memory and attention problems by using either one of two software versions of the program. One version is called Cogmed Working Memory Training, and the other is a comparison version of the software that has the same exercises but is less difficult. People who decide to participate in the study will be randomly given one of the two versions. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE | Breast Cancer | |||
Intervention ICMJE | Behavioral: Cogmed Working Memory Training Program
Women will be randomized to one of two 5-week rehabilitation software training programs that train working memory called Cogmed Working Memory Training Program. The training software will be provided to each participant. For each group, training occurs for 30 minutes a day, 5 days a week for 5 weeks. As part of the set-up, training data is uploaded to the internet at a minimum of every 3 days. This function allows the "coach" (in this case, the PI and RSA) to review the training. A weekly "coach" phone call is made to review the training results, answer questions, troubleshoot, and motivate the participant. Participants can load the software onto multiple computers to provide flexibility for them to do training at home, after work, when they are away from home. |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Estimated Enrollment ICMJE |
60 | |||
Original Estimated Enrollment ICMJE |
52 | |||
Estimated Study Completion Date | August 2018 | |||
Estimated Primary Completion Date | August 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Note: Any participant who reports tics can be included, however participants will be told tics may increase during the training period. Inclusion Criteria: Patients
Collateral Participant (if such person is available to the participant, not a requirement of the study) Family member or friend (i.e., collateral) identified by a patient who has at least weekly face to face contact with the patient
Exclusion Criteria: Patients
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Sex/Gender |
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Ages | 18 Years to 69 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01182506 | |||
Other Study ID Numbers ICMJE | 10-105 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Memorial Sloan Kettering Cancer Center | |||
Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | |||
Collaborators ICMJE | MARTELL FOUNDATION | |||
Investigators ICMJE |
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PRS Account | Memorial Sloan Kettering Cancer Center | |||
Verification Date | September 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |