Digital Intervention Targeting Cancer-related Cognitive Impairments

Not Applicable

Not yet recruiting

• Conditions: Cancer; Cognitive Impairment

• Registration Number: NCT06693102
• Lead Sponsor: Haukeland University Hospital

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?

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-15
• Last Update Submitted: 2024-11-15
• Study First Posted: 2024-11-18
• Last Update Posted: 2024-11-18
• Study Start: 2025-01-02
• Primary Completion: 2028-01-02
• Study Completion: 2028-01-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Functional Assessment of Cancer Therapy- Cognitive Function	pre-assessment to two-year follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Digit Span Wechsler Adult Intelligence Scale-IV	Pre- to six-month follow-up assessments	Digit Span Wechsler Adult Intelligence Scale-IV measures auditory attention span and working memory. Numbers are read aloud to participants, who repeat the sequence. The sequence length increases, and participants also repeat sequences backward. This test

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway