Digital Intervention Targeting Cancer-related Cognitive Impairments

NCT06693102 | Not Yet Recruiting

• 1 other identifier: 742333
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Cognitive Impairment

Keywords

cancer survivors; cancer-related cognitive impairments; cognitive remediation; cognitive training; cognitive challenges

Outcome Measures

Primary Outcomes (1)

• The Functional Assessment of Cancer Therapy- Cognitive Function

  The Functional Assessment of Cancer Therapy- Cognitive Function (FACT-Cog) is a validated questionnaire consisting of 37 items designed to assess cognitive difficulties in cancer survivors. It includes four subscales: perceived cognitive impairment, cognitive abilities, feedback from others, and the impact of cognitive decline on quality of life. Total scores ranges from 0-148. Higher scores indicate better cognitive function.

  pre-assessment to two-year follow-up

Secondary Outcomes (1)

• Digit Span Wechsler Adult Intelligence Scale-IV

  Pre- to six-month follow-up assessments

Other Outcomes (9)

• Rumination response scale

  pre- to two year follow-up assessment

• Patient Health Questionnaire-9

  Pre- to two-year follow-up assessment

• The Functional Assessment of Chronic Illness Therapy-Fatigue

  Pre- to two years follow-up assessments

Study Arms (2)

Digital intervention targeting cancer related cognitive imapriments.

EXPERIMENTAL

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.

Behavioral: Digital intervention targeting cancer-related cognitive impairments

Crossword and sudoku tasks

ACTIVE COMPARATOR

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

Behavioral: Crossword and sudoku taks

Interventions

Digital intervention targeting cancer-related cognitive impairments 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.

Digital intervention targeting cancer related cognitive imapriments.

Crossword and sudoku taks BEHAVIORAL

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

Crossword and sudoku tasks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years,
• Self-reported cognitive difficulties that are perceived to impact daily functioning (PCI \<44 FACT-Cog),
• Have received cancer treatment,
• Completed curative treatment at least six months prior,
• Proficient in speaking and writing Norwegian,
• Access to a computer, tablet, or smartphone, and the internet.

You may not qualify if:

• Neurological disorders (e.g., ADHD, MS, autism),
• History of severe head injury,
• Current moderate or severe depression (PHQ-9 score \>14),
• Previously diagnosed with serious mental disorders, such as substance abuse, bipolar disorder, or psychotic disorders.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• The Research Council of Norway: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, 5002, Norway

Location

MeSH Terms

Conditions

Neoplasms; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Sunniva Brurok Myklebost, PhD

CONTACT

0047 55556767; sunniva.brurok.myklebost@helse-bergen.no

tine Nordgreen, PhD

CONTACT

0047 55 559862; tine.nordgreen@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants are not randomized before all pre-assessment questionnaires and tests are completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 18, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): January 2, 2028
• Study Completion (Estimated): January 2, 2028
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

NO (1)