Breast Cancer Clinical Trial
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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