CancerNCT06693102
Digital Intervention Targeting Cancer-related Cognitive Impairments
A study testing Digital intervention targeting cancer-related cognitive impairments and Crossword and sudoku taks in people with Cancer and Cognitive Impairment, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cancer, Cognitive Impairment
- What is being tested?
- Digital intervention targeting cancer-related cognitive impairments and Crossword and sudoku taks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 2 Jan 2025to 2 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site
Haukeland University Hospital
Bergen, 5002
Sunniva Brurok Myklebost, PhD, 0047 55556767, sunniva.brurok.myklebost@helse-bergen.no
Sunniva Brurok Myklebost, PhD
About this study
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.
Read the 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?
- Conditions
- Cancer, Cognitive Impairment
- Being tested
- Digital intervention targeting cancer-related cognitive impairments, Crossword and sudoku taks
- Keywords
- cancer survivors, cancer-related cognitive impairments, cognitive remediation, cognitive training, cognitive challenges
- Medical subject headings
- Neoplasms, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital intervention targeting cancer-related cognitive impairmentsBehavioural
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 taksBehavioural
Participants receive crossword and sudoku tasks. They are encourraged to solve such tasks for a minimum of 15 minutes daily for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Crossword and sudoku taks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-assessment to two-year follow-up
Secondary outcomes (1)
Digit Span Wechsler Adult Intelligence Scale-IV
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
Measured: Pre- to six-month follow-up assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start2 Jan 2025 (estimated)
- Primary completion2 Jan 2028 (estimated)
- Study completion2 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693102
- Sponsor's protocol ID
- 742333
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymous data may be shared upon reasonable request, subject to restrictions imposed by data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Intervention Targeting Cancer-related Cognitive Impairments
- ClinicalTrials.gov ID
- NCT06693102
- Acronym / sponsor ID
- 742333
- Conditions
- Cancer, Cognitive Impairment
- Keywords
- cancer survivors, cancer-related cognitive impairments, cognitive remediation, cognitive training, cognitive challenges
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- 2 Jan 2025 (estimated)
- Primary completion
- 2 Jan 2028 (estimated)
- Study completion
- 2 Jan 2028 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital intervention targeting cancer related cognitive imapriments. | Experimental | Behavioral: Digital intervention targeting cancer-related cognitive impairmentsParticipants 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. |
| Crossword and sudoku tasks | Active comparator | Behavioral: Crossword and sudoku taksParticipants will engage in crossword and Sudoku tasks, with a minimum recommended practice of 15 minutes per day over a six-week period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital intervention targeting cancer-related cognitive impairmentsThe 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. | Behavioural | Digital intervention targeting cancer related cognitive imapriments. |
| Crossword and sudoku taksParticipants receive crossword and sudoku tasks. They are encourraged to solve such tasks for a minimum of 15 minutes daily for six weeks. | Behavioural | Crossword and sudoku tasks |
Primary outcome
The Functional Assessment of Cancer Therapy- Cognitive Function
Time frame: 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.
1 secondary outcome
Digit Span Wechsler Adult Intelligence Scale-IV
Time frame: Pre- to six-month follow-up assessments
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: Undecided. Anonymous data may be shared upon reasonable request, subject to restrictions imposed by data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital intervention targeting cancer-related cognitive impairments and Crossword and sudoku taks in people with Cancer and Cognitive Impairment, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sunniva Brurok Myklebost, PhD (0047 55556767, sunniva.brurok.myklebost@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Functional Assessment of Cancer Therapy- Cognitive Function (time frame: pre-assessment to two-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.