NCT01866813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 12, 2015

Status Verified

May 1, 2013

Enrollment Period

1.7 years

First QC Date

May 21, 2013

Last Update Submit

January 9, 2015

Conditions

Breast Cancer

Keywords

breast cancercancer survivors

Outcome Measures

Primary Outcomes (2)

  • Paced auditory serial addition test

    Measures of working memory and concentration as primary outcome.

    6 wks post-intervention

  • Paced auditory serial addition test

    27 wks followup

Secondary Outcomes (2)

  • Cognitive failures questionnaire

    6 wks post-intervention

  • cognitive failures questionnaire

    27 wks follow-up

Other Outcomes (2)

  • cognitive functioning

    6 wks post-intervention

  • cognitive functioning

    27 wks follow-up

Study Arms (2)

Waiting list control group

NO INTERVENTION

Waiting list control group who is offered cognitive training at the end of the data collection period.

Cognitive training intervention group

EXPERIMENTAL

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

Interventions

Cognitive training intervention groupBEHAVIORAL

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.

Also known as: Scientific Brain Training Pro
Cognitive training intervention group

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit for Psychooncology and Health Psychology Dept. of Oncology, Aarhus University Hospital and Dept of Psychology, Aarhus University

Aarhus, AAarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Robert Zachariae, P.MDSci,MSc.

    Unit for Psychooncology and Health Psychology Dept. of Oncology, Aarhus University Hospital and Dept of Psychology, Aarhus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2013

First Posted

May 31, 2013

Study Start

May 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 12, 2015

Record last verified: 2013-05

Locations

DK(1)