UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047104 |
|---|---|
| Receipt number | R000053710 |
| Scientific Title | A scoping review of assessment tools and cognitive domains for chemotherapy-induced cognitive impairments in cancer survivors |
| Date of disclosure of the study information | 2022/03/08 |
| Last modified on | 2023/03/08 11:14:50 |
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Basic information
Public title
A scoping review of assessment tools and cognitive domains for chemo brain in cancer survivors
Acronym
A scoping review of assessments for chemo brain
Scientific Title
A scoping review of assessment tools and cognitive domains for chemotherapy-induced cognitive impairments in cancer survivors
Scientific Title:Acronym
A scoping review of assessments for chemotherapy-induced cognitive impairments
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Medicine in general | Surgery in general | Not applicable |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aims of this review were: (1) to identify studies that evaluate the chemotherapy-induced cognitive impairments
Basic objectives2
Others
Basic objectives -Others
(2) to identify the cognitive-related assessment tools used in these studies and the domains they target; and (3) to identify common tools by mapping the cognitive domains reported in the studies using a common ICF framework.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Neuropsychological assessment tool
Key secondary outcomes
Patient reported outcome
Neuroimaging assessment tool
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We searched three online databases: PubMed, CINAHL, and Web of Science. Search limits included peer-reviewed studies, published in English, by October 1st, 2021. The commencing year limit was not set, and all research articles were traced back.
The inclusion criterion for the present review was the prospective study principally investigated the effects of chemotherapy on cognition for adults with cancer. However, studies that investigated other cancer treatments separately from chemotherapy were included if they had a chemotherapy treatment group alone.
Key exclusion criteria
The exclusion criteria for our study are as follows: (1) no abstract (2) languages other than English (3) review article, interventional trial, and case study (4) experiments with animals (5) primary brain tumor or brain metastasis (6) unclear distinction between hormone therapy and radiation therapy (7) having any other reason that the reviewer finds to be an obvious content discrepancy. As an example of this content inconsistency, in order to examine the effect of chemotherapy treatment on cognitive impairment more purely, we excluded cases in which the main topic of the previous study was considered by the reviewers to be strongly influenced by depression, anxiety, fatigue, or anemia.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Amano |
Organization
Kitasato University
Division name
Department of Rehabilitation Medicine
Zip code
252-0373
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, JAPAN
TEL
(042)-778-9849
s-amano@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Saita |
Organization
Hiroshima University
Division name
Graduate school of Biomedical and Health Sciences
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-Ku, Hiroshima, JAPAN
TEL
082-257-5452
Homepage URL
saita@hiroshima-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI (21K20286)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University
Address
1-2-3, Kasumi, Minami-Ku, Hiroshima, JAPAN
Tel
082-257-5452
saita@hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 08 | Day |
Related information
URL releasing protocol
https://www.frontiersin.org/articles/10.3389/fnhum.2023.1063674/full
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fnhum.2023.1063674/full
Number of participants that the trial has enrolled
64
Results
Sixty-four prospective studies were included after checking for eligibility. The neuropsychological tests (NPTs) were divided into seven main cognitive domains. The specific mental functions were often used in the order of memory, attention, higher-level cognitive functions, and psychomotor functions. Perceptual functions were used less frequently. The Functional Assessment of Cancer Therapy-Cognitive function (FACT-Cog) was a shared consensus tool among the patient-reported outcomes (PROs).
Results date posted
| 2023 | Year | 03 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 02 | Month | 20 | Day |
Baseline Characteristics
The inclusion criteria: the studies must have principally investigated the effects of chemotherapy on cognition in adults with cancer.
The exclusion criteria for our study were as follows: (1) no abstract, (2) languages other than English, (3) review article, interventional trial, and case study, (4) experiments with animals, (5) primary brain tumor or brain metastasis, (6) unclear distinction between hormonal therapy and radiotherapy, (7) having any other reason that the reviewer finds to be an obvious content discrepancy. An example of this content inconsistency is when there is a claim to an exclusive examination of the effect of chemotherapy treatment on cognitive impairment, but reviewers have considered the impairment to be strongly influenced by depression, anxiety, fatigue, or anemia.
Participant flow
The study followed the recommendations made by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. We searched the following three databases through October 2021: PubMed, CINAHL, and Web of Science. Prospective longitudinal or cross-sectional studies were selected to determine CICI-specific assessment tools for adult cancer survivors.
Adverse events
No adverse events
Outcome measures
neuropsychological tests, patient-reported outcomes, neuroimaging
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 07 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aims of this review were: (1) to identify studies that evaluate the chemotherapy-induced cognitive impairments; (2) to identify the cognitive-related assessment tools used in these studies and the domains they target; and (3) to identify common tools by mapping the cognitive domains reported in the studies using a common ICF framework.
Management information
Registered date
| 2022 | Year | 03 | Month | 07 | Day |
Last modified on
| 2023 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053710
