Cognitive Stimulation Intervention Program for Cancer Survivors and Its Benefit on Cognitive Performance and Quality of Life
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Universidad Antonio de Nebrija
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change from Baseline in the Functionality Assessment Instrument in Cancer Treatment - Cognitive Function (FACT-COG) at Week 8
- Last Updated
- 3 years ago
Overview
Brief Summary
The present study aims to establish a non-pharmacological alternative in alleviating cognitive deterioration derived from undergoing chemotherapy treatment. Thus, the effectiveness of a personalized and computerized cognitive stimulation program in breast cancer survivors is assessed.
Detailed Description
A phase I/II/III clinical trial is proposed in which the first two phases will serve to evaluate the safety of the intervention and the maximum tolerated time of computerized cognitive training per session in the absence of adverse effects. The third phase will consist of a double-blind randomized controlled trial where the effectiveness of the personalized and self-administered computerized cognitive stimulation program will be evaluated. Phase I. Based on a dose-escalation 3+3 design, experienced fatigue or adverse effects will be measured after succeeding 15 minutes cognitive stimulation training blocks. The training dose will be set to a block before extreme fatigue or notable adverse effect has been reported by two or more participants. A trained psychologist will supervise the process. Phase II. To evaluate the effectiveness of the intervention, 20 participants will undertake an interspersed training day and evaluation day through 15 consecutive days. In this way, a total of 8 evaluation sessions (day 1, 3, 5, 7, 9, 11, 13, and 15) and 7 cognitive stimulation sessions (day 2, 4, 6, 8, 10, 12, and 14) will be carried out. A trained psychologist will supervise every step of the process. Phase III. An 8-week personalized and computerized cognitive stimulation program will be established, where the training time per session will be as determined on phase I. 120 participants will be randomized 1:1 ratio to an intervention or active control group. All participants will undertake a pre and post-test, with a total of 40 training sessions (Monday to Friday) during 8 weeks. Although this phase is set to be an online home-based stage, the responsible psychologist will be monitoring participants' performance and will periodically contact participants via telephone.
Investigators
Jon Andoni Duñabeitia
Director
Universidad Antonio de Nebrija
Eligibility Criteria
Inclusion Criteria
- •Have been diagnosed with breast cancer.
- •Having undergone chemotherapy.
- •Report objective or subjective complaints of cognitive impairment.
Exclusion Criteria
- •Metastases or brain tumors.
- •Existence of a relevant medical, psychiatric, or neurological disorder.
- •Significant visual or motor impairments.
- •History of alcohol or drug abuse or dependence.
- •Be receiving another cognitive stimulation intervention.
Outcomes
Primary Outcomes
Change from Baseline in the Functionality Assessment Instrument in Cancer Treatment - Cognitive Function (FACT-COG) at Week 8
Time Frame: Baseline and Week 8
The FACT-COG is a 37 item self-report questionnaire that assesses patients' perception of their cognitive abilities, functionality, and quality of life. Each item is scored using a 5-point Likert scale. Higher scores indicate less perceived cognitive impairment.
Change from Baseline in mini-Mental Adjustment to Cancer Scale (mini-MAC) at Week 8
Time Frame: Baseline and Week 8
The mini-MAC is a validated 29-item self-rated questionnaire that examines five cancer-specific coping strategies: fighting spirit, helplessness, anxious preoccupation, cognitive avoidance, and fatalism. Each item is scored using a 4-point Likert scale. Higher scores on each subscale mean greater use of that strategy.
Change from Baseline in Cognitive Assessment for Chemo Fog Research (CAB-CF) at Week 8
Time Frame: Baseline and Week 8
The CAB-CF is an online neuropsychological assessment battery that evaluates a total of 23 cognitive skills, grouped into 5 cognitive domains (attention, memory, coordination, perception, and reasoning). Each cognitive skill is scored from 0 to 800. The cognitive domain score is calculated by averaging the scores of the cognitive skills that comprise it. Higher scores mean better cognitive performance.
Secondary Outcomes
- Change from Baseline in the State-Trait Anxiety Inventory (STAI) at Week 8(Baseline and Week 8)
- Change from Baseline in the Brief Fatigue Inventory (BFI) at Week 8(Baseline and Week 8)
- Change from Baseline in the Measuring Quality of Life | The World Health Organization - abridged version (WHOQOL-BREF) at Week 8(Baseline and Week 8)
- Change from Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) at Week 8(Baseline and Week 8)
- Change from Baseline in the Beck Depression Inventory (BDI-II) at Week 8(Baseline and Week 8)