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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive training intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paced auditory serial addition test
Measures of working memory and concentration as primary outcome.
Measured: 6 wks post-intervention
Paced auditory serial addition test
Measured: 27 wks followup
Secondary outcomes (2)
Cognitive failures questionnaire
Measured: 6 wks post-intervention
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.
- First posted31 May 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Zachariae, P.MDSci,MSc., Principal investigator, Unit for Psychooncology and Health Psychology Dept. of Oncology, Aarhus University Hospital and Dept of Psychology, Aarhus University
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility And Efficacy Of An Internet-Delivered Cognitive Training Program For Breast Cancer Survivors With Cognitive Complaints
- ClinicalTrials.gov ID
- NCT01866813
- Acronym / sponsor ID
- 1-10-72-52-1
- Conditions
- Breast Cancer
- Keywords
- breast cancer, cancer survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Cognitive training intervention groupCognitive 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previously treated for breast cancer
- self-reported cognitive deficits
- are found to be disease free
- are required to have access to the Internet.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive training intervention groupAlso: Scientific Brain Training ProThe 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. | Behavioural | Cognitive training intervention group |
Primary outcome
Paced auditory serial addition test
Time frame: 6 wks post-intervention
Measures of working memory and concentration as primary outcome.
Paced auditory serial addition test
Time frame: 27 wks followup
2 secondary outcomes
Cognitive failures questionnaire
Time frame: 6 wks post-intervention
cognitive failures questionnaire
Time frame: 27 wks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Zachariae, P.MDSci,MSc. principal investigator
Unit for Psychooncology and Health Psychology Dept. of Oncology, Aarhus University Hospital and Dept of Psychology, Aarhus University
1 site in 1 country: see every site and its status.
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.