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Internet-Delivered Cognitive Training For Breast Cancer Survivors With Cognitive Complaints

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ClinicalTrials.gov Identifier: NCT01866813
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : January 12, 2015
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
The aim of the proposed study is to investigate whether women treated for breast cancer who experience cognitive difficulties will profit from the Internet-based program Scientific Brain Training Pro with respect to: 1) attention, working memory, learning and recall, and executive function as assessed by standardized neuropsychological tests and 2,) self-reported cognitive difficulties in daily life as measured by questionnaires.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Cognitive training intervention group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility And Efficacy Of An Internet-Delivered Cognitive Training Program For Breast Cancer Survivors With Cognitive Complaints
Study Start Date : May 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Waiting list control group
Waiting list control group who is offered cognitive training at the end of the data collection period.
Experimental: Cognitive training intervention group
Cognitive training intervention group: 6 weeks of intervention with the online cognitive training "scientific brain training pro" for 40-60 minutes a day/ 5 days a week. Reminders and motivational phone-calls throughout the intervention period. Phone and Internet-based technical support is available.
Behavioral: Cognitive training intervention group
The intervention group will be asked to participate in an internet-delivered cognitive training pro-gram using the Danish edition of Scientific Brain Training Pro on their home personal computer. The software is provided through the Internet, and no software installation is needed onto the participant personal computer. Reminders to train will be provided by e-mail. The training involves working with the program for 40-60 minutes a day, five days a week, for six weeks.
Other Name: Scientific Brain Training Pro




Primary Outcome Measures :
  1. Paced auditory serial addition test [ Time Frame: 6 wks post-intervention ]
    Measures of working memory and concentration as primary outcome.

  2. Paced auditory serial addition test [ Time Frame: 27 wks followup ]

Secondary Outcome Measures :
  1. Cognitive failures questionnaire [ Time Frame: 6 wks post-intervention ]
  2. cognitive failures questionnaire [ Time Frame: 27 wks follow-up ]

Other Outcome Measures:
  1. cognitive functioning [ Time Frame: 6 wks post-intervention ]
  2. cognitive functioning [ Time Frame: 27 wks follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously treated for breast cancer
  • self-reported cognitive deficits
  • are found to be disease free
  • are required to have access to the Internet.

Exclusion Criteria:

  • head trauma with loss of consciousness
  • neurological disease
  • severe physical or psychological disease
  • alcoholism or drug abuse,
  • Danish as a second-language (i.e. are not born and raised in Denmark)
  • recurrence of breast cancer
  • a second cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866813


Locations
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Denmark
Unit for Psychooncology and Health Psychology Dept. of Oncology, Aarhus University Hospital and Dept of Psychology, Aarhus University
Aarhus, AAarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Robert Zachariae, P.MDSci,MSc. Unit for Psychooncology and Health Psychology Dept. of Oncology, Aarhus University Hospital and Dept of Psychology, Aarhus University

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01866813     History of Changes
Other Study ID Numbers: 1-10-72-52-1
1-10-72-52-13 ( Other Identifier: Committee on Biomedical Research Ethics )
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: January 12, 2015
Last Verified: May 2013

Keywords provided by University of Aarhus:
breast cancer
cancer survivors

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases