Clinical trial NCT06693102: Digital Intervention Targeting Cancer-related Cognitive Impairments
Official title: Digital Intervention Targeting Cancer-related Cognitive Impairments
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Cognitive Impairment
Keywords: cancer survivors
cancer-related cognitive impairments
cognitive remediation
cognitive training
cognitive challenges
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2024-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

Eligibility criteria: The target group consists of individuals who have previously undergone cancer treatment (N=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.

Primary outcomes:
measure: The Functional Assessment of Cancer Therapy- Cognitive Function
timeFrame: pre-assessment to two-year follow-up
Secondary outcomes:
measure: Digit Span Wechsler Adult Intelligence Scale-IV
timeFrame: Pre- to six-month follow-up assessments
Other outcomes:
measure: Rumination response scale
timeFrame: pre- to two year follow-up assessment
measure: Patient Health Questionnaire-9
timeFrame: Pre- to two-year follow-up assessment
measure: The Functional Assessment of Chronic Illness Therapy-Fatigue
timeFrame: Pre- to two years follow-up assessments
measure: The Satisfaction with Life Scale
timeFrame: Pre-assessment to two-year follow-up
measure: Credibility and Expectancy Questionnaire
timeFrame: First week after receiving the intervention.
measure: California Verbal Learning Test II
timeFrame: Pre- to six-month follow-up assessments.
measure: Color-Word Interference Test Delis-Kaplan Executive Function System
timeFrame: Pre- to six month follow-up assessments.
measure: Word and Category Fluency Delis-Kaplan Executive Function System
timeFrame: Pre- six month follow-up assessments.
measure: The Generalized Anxiety Disorder-7
timeFrame: Pre-assessment to two-year follow-up.
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
References: