UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061691 |
|---|---|
| Receipt number | R000070589 |
| Scientific Title | A Scoping Review on the Components of "Time Toxicity" in Patients with Advanced Cancer and Their Families. |
| Date of disclosure of the study information | 2026/05/26 |
| Last modified on | 2026/05/26 12:29:26 |
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Basic information
Public title
A Scoping Review on the Components of "Time Toxicity" in Patients with Advanced Cancer and Their Families.
Acronym
A Scoping Review on the Components of "Time Toxicity" in Patients with Advanced Cancer and Their Families.
Scientific Title
A Scoping Review on the Components of "Time Toxicity" in Patients with Advanced Cancer and Their Families.
Scientific Title:Acronym
A Scoping Review on the Components of "Time Toxicity" in Patients with Advanced Cancer and Their Families.
Region
| Japan |
Condition
Condition
To comprehensively map the factors (physical, psychological, social, and relational aspects) that constitute the time-related toxicity experienced by patients with advanced cancer and their families.
Classification by specialty
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To comprehensively map the factors (physical, psychological, social, and relational aspects) that constitute the time-related toxicity experienced by patients with advanced cancer and their families.
Basic objectives2
Others
Basic objectives -Others
To comprehensively map the factors (physical, psychological, social, and relational aspects) that constitute the time-related toxicity experienced by patients with advanced cancer and their families.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Multifaceted Structure of Time Toxicity as Experienced by Patients and Their Families.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Cancer patients or patients with chronic diseases (defined as conditions requiring continuous management or treatment for three months or longer), as well as their families or caregivers.
2. Healthcare professionals (nurses, physicians, etc.) who address perceptions of or provide support related to time toxicity.
3. Concepts related to "time toxicity," "time burden/cost," or research whose primary objective is time toxicity. or concepts related to treatment burden that include a temporal aspect.
4. Studies addressing the content that patients, families, and healthcare providers recognize and experience as time consumption associated with medical care or convalescence (e.g., hospital visits, waiting times, tests, treatments, self-management, caregiving, and convalescence coordination).
5. Studies addressing the impact of time burden on daily life, quality of life (QOL), decision-making, daily activities, and social life.
6. Research on the narratives, experiences, and perceptions of patients, families, and healthcare providers.
7. Research that measures, evaluates, or quantifies the time burden associated with medical care and treatment.
8. Research dealing with time-related indicators such as the number of clinic visits, travel time to clinics, waiting time, treatment time, self-management time, caregiving time, and time spent in medical encounters.
9. Research addressing the impact of time burden on QOL, functional ability, employment, social participation, decision-making, and other areas.
Key exclusion criteria
1. The study is a duplicate.
2. The study is a conference presentation.
3. The study does not address the time spent by patients, their families, and healthcare providers in relation to medical care or treatment.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Saori |
| Middle name | |
| Last name | Kashiwa |
Organization
Mie University
Division name
Graduate School of Medicine
Zip code
514-8507
Address
2-174 Edobashi,Tsu
TEL
09014369436
326D101@m.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Kshiwa |
Organization
Mie University
Division name
Graduate School of Medicine
Zip code
514-8507
Address
2-174 Edobashi,tsu
TEL
09014369436
Homepage URL
326D101@m.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
| 2026 | Year | 05 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Search Method:
We will conduct a comprehensive literature search to identify the factors (physical, psychological, social, and relational aspects) that constitute the time toxicity experienced by patients with advanced cancer and their families. For this search, we plan to use electronic databases such as PubMed and CINAHL to identify all literature published up to May 21, 2026, using keywords such as "time toxicity" and "time burden."
2. Screening Method:
Two or more researchers will independently screen the literature based on the selection criteria to determine which studies to include. If researchers disagree on the evaluation of a study, they will consult with one another to decide on its inclusion or exclusion. If consensus cannot be reached, a third party will be consulted to make the final decision.
Management information
Registered date
| 2026 | Year | 05 | Month | 26 | Day |
Last modified on
| 2026 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070589
