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Breast CancerNCT01866813

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

A study testing Cognitive training intervention group in people with Breast Cancer, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Cognitive training intervention group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteDenmark
Study dates
May 2013to Jan 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Unit for Psychooncology and Health Psychology Dept. of Oncology, Aarhus University Hospital and Dept of Psychology, Aarhus University

    Aarhus, AAarhus, 8000

Other trials in Denmark

About this study

Official title: Feasibility And Efficacy Of An Internet-Delivered Cognitive Training Program For Breast Cancer Survivors With Cognitive Complaints

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.

Read the detailed description

Studies within the last decade indicate that many cancer patients and survivors experience cognitive deficits such as impaired memory and concentration after diagnosis and treatment.

The cognitive deficits are seen as a complication of cancer treatment and have generally been attributed to chemotherapy, hence the term "chemo brain". However, more recent research indicates that chemotherapy is probably not the only cause of cognitive deficits as several cancer patients (23-33%) have impaired cognitive functions even before therapy is initiated, and other findings suggest that former cancer patients have lower levels of cognitive functioning regardless of treatment status.

The cognitive profile of cancer patients indicates involvement of frontal-subcortical dysfunction affecting processing speed, attention, working memory, learning and recall, and executive function. Cancer patients often report that their cognitive capacity in daily life has deteriorated. In qualitative interviews, women with breast cancer describe that they experience memory problems at work, whilst women on sick leave worry that their cognitive impairment will be an issue when they return to work. Among former breast cancer patients, it has been reported that perceived cognitive limitations were associated with reduced work capacity.

Cognitive rehabilitation of former cancer patients is an important concern, since even mild cognitive dysfunction may have significant impact on their return to and welfare at work and other aspects of everyday living. Although several cancer patients express an interest in interventions aimed at alleviating their perceived cognitive deficits, only two studies so far have assessed the effect of cognitive intervention in former cancer patients. Ferguson and colleagues devised a cognitive training program focusing on relaxation techniques and compensatory strategies in order to improve everyday skills. The program consisted of four individual consultations with a total of three phone consultations in between. The program was tested in a non-randomized design with 29 breast cancer patients who had completed chemotherapy at least 3 years earlier. They found improvement in tests of attention, memory and executive function, and participants experienced improvement in daily cognitive functioning.

In a randomized controlled design, Poppelreuter and colleagues tested two interventions for improving attention and memory in a group of breast cancer patients. Both interventions consisted of four one-hour sessions per week. On average, there were 11.5 sessions per patient. The two interventions included groups of max 8 participants led by occupational therapists with memory and attention training in relation to activities of daily living (n = 33) and a group undergoing individual computer-based training of attention and memory under therapeutic supervision and subsequent coaching (n = 34). The study found general improvement in neuropsychological test scores and self-reported reduction of cognitive impairment in both intervention groups and the control group.

Due to the limited results so far, it remains unclear to what extent interventions have an effect on the cognitive deficits experienced by cancer patients and who will benefit from cognitive intervention. Recent research has shown that specific computerized brain training programs can improve cognitive functions such as working memory in individuals with congenital or contracted cognitive impairment with a measurable increase in brain activity. Given the widespread experience of impaired cognitive function among former cancer patients and the negative consequences that these problems could have on their working capacity and quality of life, it is highly relevant to examine whether similar computerized training programs can help former cancer patients. As this is likely to be a cost-effective method in relation to time, effort and costs, the perspectives in relation to implementation and dissemination are promising.

OBJECTIVES

The aim of the 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.

Conditions
Breast Cancer
Being tested
Cognitive training intervention group
Keywords
breast cancer, cancer survivors
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive training intervention groupBehavioural

    Also called Scientific Brain Training Pro

    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.

Study groups in NCT01866813
Study groupRoleWhat they receive
Waiting list control groupNo interventionWaiting list control group who is offered cognitive training at the end of the data collection period.
Cognitive training intervention groupExperimentalCognitive 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.
Receives: Behavioral: Cognitive training intervention group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Paced auditory serial addition test

    Measures of working memory and concentration as primary outcome.

    Measured: 6 wks post-intervention

  2. Paced auditory serial addition test

    Measured: 27 wks followup

Secondary outcomes (2)
  1. Cognitive failures questionnaire

    Measured: 6 wks post-intervention

  2. cognitive failures questionnaire

    Measured: 27 wks follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01866813
Sponsor's protocol ID
1-10-72-52-1
Other IDs
1-10-72-52-13
Status last verified
May 2013
First submitted
21 May 2013
Last updated
12 Jan 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive training intervention group in people with Breast Cancer, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Paced auditory serial addition test (time frame: 6 wks post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2015.

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