Digital Intervention Targeting Cancer-related Cognitive Impairments

NCT ID: NCT06693102

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-02
• Study Completion Date: 2028-01-02

Brief Summary

Cognitive deficits are frequently reported following cancer treatment and can significantly impact daily functioning. These cognitive impairments often persist for years after cancer treatment. This study aimed to examine several aspects of a newly developed digital intervention designed to address cognitive impairments. Specifically, it focused on: (1) evaluating the preliminary effects of the intervention, (2) identifying predictors of treatment response, (3) assessing the feasibility of both the intervention and the study design, (4) gathering participant feedback on the intervention, and (5) testing the applicability of the Norwegian version of the Working Memory Questionnaire within this patient group.

Detailed Description

Many cancer survivors report cognitive challenges, including problems with concentration, attention, memory, processing speed, and executive functions. These cognitive impairments can persist for years after cancer treatment and are associated with reduced functioning at home and work.

Several approaches for managing cognitive difficulties are described in the literature. One approach is drill-and-practice interventions involving repetitive cognitive training, often employing computer-based tasks that increase in difficulty. Other interventions focus on strategy-based exercises, teaching patients to apply coping strategies in everyday situations. Additionally, psychoeducation is an important component in treating cognitive impairments.

Access to interventions for cognitive impairments remains limited. This limited may be a consequence of limited healthcare professionals resources. One potential solution is to offer digital interventions. The research literature shows that digital interventions are as effective as face-to-face treatment for mental health conditions such as anxiety and depression. In a previous study, we also found that digital interventions for cognitive impairments in depression, to be feasible. Offering digital interventions for cancer-related cognitive impairments might therefore be a promising approach for addressing one of the most common late effects following cancer treatment.

This study aims to assess the preliminary effects and the feasibility of a digital intervention for cancer-related cognitive impairments. Specifically, it aims to reduce self-reported cancer-related cognitive impairments. Additionally, we will examine whether the intervention increase performance on objectively measured cognitive tests. Other outcomes are rumination, life satisfaction, fatigue, depressive symptoms, and anxiety symptoms. Qualitative feedback from participants on their experience with the intervention will be used to refine the program. We will also assess the feasibility of a recently translated questionnaire for measuring working memory in this patient group. The study will include 60 cancer survivors. Thirty of these will receive the digital intervention and 30 will receive paper and pencil crossword and sudoku tasks.

The research questions are:

1. What preliminary changes in self-reported cognitive impairments and other clinical outcomes are observed among cancer survivors after receiving the digital intervention?

2. To what extent do clinical and demographic factors influence the usage and response to a digital intervention for cognitive impairments following cancer treatment?

3. How feasible is the newly developed digital intervention for cognitive impairments?

4. How do cancer survivors experience a newly developed digital intervention for cognitive impairments?

5. How effective is the translated version of the Working Memory Assessment Questionnaire in measuring cognitive impairments among Norwegian cancer survivors?

Conditions

Cancer; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Digital intervention targeting cancer related cognitive imapriments.

Participants will undergo a digital intervention designed to address cognitive impairments. The program includes psychoeducation, cognitive training exercises, compensatory strategies, and cognitive restructuring. Weekly therapist support will be available via a chat function to provide guidance and feedback. Participants are encouraged to complete the intervention within a six-week timeframe.

Group Type: EXPERIMENTAL

Digital intervention targeting cancer-related cognitive impairments

Intervention Type: BEHAVIORAL

The intervention is developed using a person-centered approach and includes key components such as psychoeducation, cognitive training, compensatory strategy training, and cognitive restructuring exercises. Participants receive weekly remote support from a therapist and are encouraged to complete the program within a six-week period.

Crossword and sudoku tasks

Participants will engage in crossword and Sudoku tasks, with a minimum recommended practice of 15 minutes per day over a six-week period.

Group Type: ACTIVE_COMPARATOR

Crossword and sudoku taks

Intervention Type: BEHAVIORAL

Participants receive crossword and sudoku tasks. They are encourraged to solve such tasks for a minimum of 15 minutes daily for six weeks.

Interventions

Digital intervention targeting cancer-related cognitive impairments

The intervention is developed using a person-centered approach and includes key components such as psychoeducation, cognitive training, compensatory strategy training, and cognitive restructuring exercises. Participants receive weekly remote support from a therapist and are encouraged to complete the program within a six-week period.

Intervention Type: BEHAVIORAL

Crossword and sudoku taks

Participants receive crossword and sudoku tasks. They are encourraged to solve such tasks for a minimum of 15 minutes daily for six weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 65 years,

2. Self-reported cognitive difficulties that are perceived to impact daily functioning (PCI <44 FACT-Cog),

3. Have received cancer treatment,

4. Completed curative treatment at least six months prior,

5. Proficient in speaking and writing Norwegian,

6. Access to a computer, tablet, or smartphone, and the internet.

Exclusion Criteria

1. Neurological disorders (e.g., ADHD, MS, autism),

2. History of severe head injury,

3. Current moderate or severe depression (PHQ-9 score >14),

4. Previously diagnosed with serious mental disorders, such as substance abuse, bipolar disorder, or psychotic disorders.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Research Council of Norway

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Haukeland University Hospital

Bergen, , Norway

Countries

Norway

Central Contacts

Sunniva Brurok Myklebost, PhD

Role: CONTACT

sunniva.brurok.myklebost@helse-bergen.no

0047 55556767

tine Nordgreen, PhD

Role: CONTACT

tine.nordgreen@helse-bergen.no

0047 55 559862

Facility Contacts

Sunniva Brurok Myklebost, PhD

Role: primary

sunniva.brurok.myklebost@helse-bergen.no

0047 55556767

Sunniva Brurok Myklebost, PhD

Role: backup

Other Identifiers

742333

Identifier Type: -

Identifier Source: org_study_id