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Study protocol
Internet-based cognitive rehabilitation for WORking Cancer survivors (i-WORC): study protocol of a randomized controlled trial.
Kete Klaver
Antoni van Leeuwenhoek Nederlands Kanker Instituut
Corresponding Author
ORCiD: https://orcid.org/0000-0002-6274-3198
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background Cognitive problems are common in non-central nervous system cancer survivors. These problems are perceived as an important contributor to decline in work performance and work ability. Various interventions for cognitive problems have been proposed, but effectiveness regarding work-related outcomes has not yet been established. Effective treatment options to alleviate the adverse influence of cognitive problems on work performance are needed for working cancer survivors. In this paper, we will describe the design of a randomized, controlled, multicenter trial that evaluates the (cost-)effectiveness of an internet-based cognitive rehabilitation program for occupationally active cancer survivors confronted with cognitive problems.
Methods/ Design A three-armed randomized controlled trial will be conducted, including two intervention groups (i.e., basic and extensive cognitive rehabilitation program) and one waitlist control group. In total, 261 cancer survivors (18 – 65 years) who have returned to work, and who experience cognitive problems will be recruited. Patients with and without cognitive impairment as established in a neuropsychological assessment, will be eligible; stratification will take place based on the presence of this cognitive impairment. The extensive intervention arm will contain a comprehensive training program (including psycho-education, fatigue management, and cognitive strategy training) with individual guidance (blended intervention). The basic intervention arm will contain a brief cognitive training program (including psycho-education and fatigue management) without individual guidance. The primary outcome will be accomplishment of an individually defined work-related treatment goal. Secondary outcomes include, among others, subjective cognitive functioning, work functioning, and quality of life. Primary and secondary outcomes will be measured at baseline (T0), and at 12 weeks (T1) and 26 weeks (T2) post-randomization.
Discussion About 40-50% of the cancer patients worldwide are of working age at time of diagnosis. Many of the occupationally active cancer survivors experience cognitive problems. Both from an individual and a societal perspective, it is important to sustain cancer survivors’ employability. An effective treatment to alleviate the impact of cognitive decline and to improve work ability might help cancer survivors to sustain employability.
Trial registration The trial is registered at ClinicalTrials.gov (NCT03900806) at 03 April 2019 (current status: ongoing),https://clinicaltrials.gov/ct2/show/NCT03900806?term=NCT03900806&draw=2&rank=1.
Keywords
Cancer-related cognitive impairment, Cognitive rehabilitation, Employment, Internet-based, Randomized controlled trial, Cost-effectiveness
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CURRENT STATUS: Published
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Posted 18 May, 2020
Published
On 20 Jul, 2020
No community comments so far
Editorial decision: Minor revision
On 05 Jun, 2020
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Reviewer #2 agreed
On 26 May, 2020
Review #1 received
Received 19 May, 2020
Reviewers invited
Invitations sent on 18 May, 2020
Reviewer #1 agreed
On 18 May, 2020
Editor assigned
On 14 May, 2020
Submission checks complete
On 13 May, 2020
No comments provided
Editorial decision: Minor revision
On 24 Apr, 2020
Review #2 received
Received 22 Apr, 2020
Review #3 received
Received 22 Apr, 2020
Reviewer #3 agreed
On 04 Apr, 2020
Review #1 received
Received 01 Apr, 2020
Reviewer #2 agreed
On 30 Mar, 2020
Reviewers invited
Invitations sent on 27 Mar, 2020
Reviewer #1 agreed
On 27 Mar, 2020
Editor assigned
On 26 Mar, 2020
Submission checks complete
On 21 Mar, 2020
First submitted
On 24 Feb, 2020
Metrics
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PDF Downloads: ...
HTML Views: ...
Subject Areas
Cancer Biology
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Internet-based cognitive rehabilitation for WORking Cancer survivors (i-WORC): study protocol of a randomized controlled trial.
Kete Klaver
Antoni van Leeuwenhoek Nederlands Kanker Instituut
Corresponding Author
ORCiD: https://orcid.org/0000-0002-6274-3198
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 2
Posted 18 May, 2020
Published
On 20 Jul, 2020
No community comments so far
Editorial decision: Minor revision
On 05 Jun, 2020
Review #2 received
Received 04 Jun, 2020
Reviewer #2 agreed
On 26 May, 2020
Review #1 received
Received 19 May, 2020
Reviewers invited
Invitations sent on 18 May, 2020
Reviewer #1 agreed
On 18 May, 2020
Editor assigned
On 14 May, 2020
Submission checks complete
On 13 May, 2020
No comments provided
Editorial decision: Minor revision
On 24 Apr, 2020
Review #2 received
Received 22 Apr, 2020
Review #3 received
Received 22 Apr, 2020
Reviewer #3 agreed
On 04 Apr, 2020
Review #1 received
Received 01 Apr, 2020
Reviewer #2 agreed
On 30 Mar, 2020
Reviewers invited
Invitations sent on 27 Mar, 2020
Reviewer #1 agreed
On 27 Mar, 2020
Editor assigned
On 26 Mar, 2020
Submission checks complete
On 21 Mar, 2020
First submitted
On 24 Feb, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Cancer Biology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background Cognitive problems are common in non-central nervous system cancer survivors. These problems are perceived as an important contributor to decline in work performance and work ability. Various interventions for cognitive problems have been proposed, but effectiveness regarding work-related outcomes has not yet been established. Effective treatment options to alleviate the adverse influence of cognitive problems on work performance are needed for working cancer survivors. In this paper, we will describe the design of a randomized, controlled, multicenter trial that evaluates the (cost-)effectiveness of an internet-based cognitive rehabilitation program for occupationally active cancer survivors confronted with cognitive problems.
Methods/ Design A three-armed randomized controlled trial will be conducted, including two intervention groups (i.e., basic and extensive cognitive rehabilitation program) and one waitlist control group. In total, 261 cancer survivors (18 – 65 years) who have returned to work, and who experience cognitive problems will be recruited. Patients with and without cognitive impairment as established in a neuropsychological assessment, will be eligible; stratification will take place based on the presence of this cognitive impairment. The extensive intervention arm will contain a comprehensive training program (including psycho-education, fatigue management, and cognitive strategy training) with individual guidance (blended intervention). The basic intervention arm will contain a brief cognitive training program (including psycho-education and fatigue management) without individual guidance. The primary outcome will be accomplishment of an individually defined work-related treatment goal. Secondary outcomes include, among others, subjective cognitive functioning, work functioning, and quality of life. Primary and secondary outcomes will be measured at baseline (T0), and at 12 weeks (T1) and 26 weeks (T2) post-randomization.
Discussion About 40-50% of the cancer patients worldwide are of working age at time of diagnosis. Many of the occupationally active cancer survivors experience cognitive problems. Both from an individual and a societal perspective, it is important to sustain cancer survivors’ employability. An effective treatment to alleviate the impact of cognitive decline and to improve work ability might help cancer survivors to sustain employability.
Trial registration The trial is registered at ClinicalTrials.gov (NCT03900806) at 03 April 2019 (current status: ongoing),https://clinicaltrials.gov/ct2/show/NCT03900806?term=NCT03900806&draw=2&rank=1.
Figure 1
Figure 2
Figure 3