Digital Intervention Targeting Cancer-related Cognitive Impairments
Study Overview
Status
Conditions
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:
- What preliminary changes in self-reported cognitive impairments and other clinical outcomes are observed among cancer survivors after receiving the digital intervention?
- To what extent do clinical and demographic factors influence the usage and response to a digital intervention for cognitive impairments following cancer treatment?
- How feasible is the newly developed digital intervention for cognitive impairments?
- How do cancer survivors experience a newly developed digital intervention for cognitive impairments?
- How effective is the translated version of the Working Memory Assessment Questionnaire in measuring cognitive impairments among Norwegian cancer survivors?
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sunniva Brurok Myklebost, PhD
- Phone Number: 0047 55556767
- Email: sunniva.brurok.myklebost@helse-bergen.no
Study Contact Backup
- Name: tine Nordgreen, PhD
- Phone Number: 0047 55 559862
- Email: tine.nordgreen@helse-bergen.no
Study Locations
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Bergen, Norway, 5002
- Haukeland University Hospital
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Contact:
- Sunniva Brurok Myklebost, PhD
- Phone Number: 0047 55556767
- Email: sunniva.brurok.myklebost@helse-bergen.no
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Contact:
- Sunniva Brurok Myklebost, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
The target group consists of individuals who have previously undergone cancer treatment (N=60).
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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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.
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Active Comparator: 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.
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Participants receive crossword and sudoku tasks.
They are encourraged to solve such tasks for a minimum of 15 minutes daily for six weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Functional Assessment of Cancer Therapy- Cognitive Function
Time Frame: pre-assessment to two-year follow-up
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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.
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pre-assessment to two-year follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Digit Span Wechsler Adult Intelligence Scale-IV
Time Frame: Pre- to six-month follow-up assessments
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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
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Pre- to six-month follow-up assessments
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Rumination response scale
Time Frame: pre- to two year follow-up assessment
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Rumination response scale (RRS) consists of 22 items measuring aspects of rumination.
Total scores ranges from 22-88.
Higher scores indicate greater levels of rumination.
The RRS can be divided into three subscales: depression-related thoughts, brooding, and reflection.
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pre- to two year follow-up assessment
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Patient Health Questionnaire-9
Time Frame: Pre- to two-year follow-up assessment
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Patient Health Questionnaire-9 (PHQ-9) onsists of nine items that assess depressive symptoms.
Scores ranges from 0-27.
Higher scores indicate more symptoms. .
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Pre- to two-year follow-up assessment
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The Functional Assessment of Chronic Illness Therapy-Fatigue
Time Frame: Pre- to two years follow-up assessments
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The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT) is a 13-item questionnaire that assesses fatigue and its implications for daily functioning.
Total scores ranges from 0 to 52.
Higher scores represents less fatigue.
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Pre- to two years follow-up assessments
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The Satisfaction with Life Scale
Time Frame: Pre-assessment to two-year follow-up
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The The Satisfaction with Life Scale (SWLS) measure life satisfaction.
Total scores ranges from 5-35.
Higher scores indicate greater level of life satisfaction.
This questionnaire consists of five items.
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Pre-assessment to two-year follow-up
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Credibility and Expectancy Questionnaire
Time Frame: First week after receiving the intervention.
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The Credibility and Expectancy Questionnaire (CEQ) measure treatment credibility and expectancy.
The rating scale ranges from 0-10 where higher scores indicate better credibility and expectancy.
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First week after receiving the intervention.
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California Verbal Learning Test II
Time Frame: Pre- to six-month follow-up assessments.
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The California Verbal Learning Test II (CVLT-II is a neuropsychological word list test measuring verbal short-term and long-term memory.
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Pre- to six-month follow-up assessments.
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Color-Word Interference Test Delis-Kaplan Executive Function System
Time Frame: Pre- to six month follow-up assessments.
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The Color-Word Interference Test, from the Delis-Kaplan Executive Function System battery (D-KEFS), consists of four subtests.
Two conditions measure processing speed and mental efficiency, where participants say the ink color of squares and read color names in black ink.
The following conditions measure inhibition and focus-shifting, with one condition requiring participants to say the ink color of incongruent words, and the last requiring participants to switch between naming ink color and reading color words depending on whether a frame surrounds the word.
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Pre- to six month follow-up assessments.
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Word and Category Fluency Delis-Kaplan Executive Function System
Time Frame: Pre- six month follow-up assessments.
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The Word and Category Fluency, from the Delis-Kaplan Executive Function System (D-KEFS), is a neuropsychological test measuring verbal fluency.
The test has three conditions: producing words that start with certain letters, naming items within categories, and alternating between categories.
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Pre- six month follow-up assessments.
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The Generalized Anxiety Disorder-7
Time Frame: Pre-assessment to two-year follow-up.
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The Generalized Anxiety Disorder-7 (GAD-7) consists of seven items that measure symptoms of anxiety.
Total scores ranges from 0-21.
Higher scores indicating more symptoms of anxiety.
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Pre-assessment to two-year follow-up.
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 742333
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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