UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054505 |
|---|---|
| Receipt number | R000062090 |
| Scientific Title | A Prospective Cohort Study of Comprehensive Supportive and Palliative Care for Patients and Families with Retinoblastoma |
| Date of disclosure of the study information | 2024/05/30 |
| Last modified on | 2025/05/19 21:31:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Cohort Study of Supportive and Palliative Care for Patients and Families with Retinoblastoma
Acronym
A Prospective Cohort Study of Comprehensive Supportive and Palliative Care for Patients and Families with Retinoblastoma
Scientific Title
A Prospective Cohort Study of Comprehensive Supportive and Palliative Care for Patients and Families with Retinoblastoma
Scientific Title:Acronym
A Prospective Cohort Study of Comprehensive Supportive and Palliative Care for Patients and Families with Retinoblastoma
Region
| Japan |
Condition
Condition
retinoblastoma
Classification by specialty
| Pediatrics | Ophthalmology | Nursing |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study will use prospective observational research to identify factors associated with the psychological, social and economic anxiety and burden of patients and their families in relation to the problems that retinoblastoma patients face from the time of diagnosis until schooling, i.e. eye removal, artificial eye, visual impairment, delayed medical care and development, and the implementation of genetic testing.
Basic objectives2
Others
Basic objectives -Others
Anxiety, depression and concern about recurrence following retinoblastoma diagnosis in patients' families.
Analysis of factors influencing anxiety, depression and concern about recurrence following retinoblastoma diagnosis.
Identification of needs related to prosthetic eye
Rate of implementation of RB1 genetic testing
Financial burden not covered by health insurance, as well as other sources.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether the RB-ePRO assessment has been continued for 6 months (more than or equal to 70% continuation)
RB-ePRO continuation is considered to be present if the third (6 months later) assessment with the Anxiety, Depression and Recurrence Concerns measurement scale (GAD-7, PHQ-9, FCRI-P) has been conducted.
Generalised Anxiety Disorder-7 (GAD-7): Generalised Anxiety Scale (Japanese version)
Patient Health Questionnaire (PHQ-9): Depression and Troubled Feelings Rating Scale (Japanese version)
Fear of Cancer Recurrence Inventory-Parent version (FCRI-P): recurrence concern scale.
Key secondary outcomes
Anxiety, depression and concern about recurrence among family members of patients after retinoblastoma diagnosis
Analysis of factors influencing anxiety, depression and concern about recurrence after retinoblastoma diagnosis
Identification of needs related to prosthetic eye
Percentage of RB1 genetic testing performed
Financial burden not covered by health insurance, etc.
Base
Study type
Observational
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
| 5 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects who fulfill all of the following criteria are eligible for the study.
1) Patients with retinoblastoma and their family members within one month of diagnosis.
2) Age less than 5 years at the time of diagnosis.
3) The patient must be visiting or being admitted to a research institution participating in this clinical study.
4) Written consent is obtained.
5) Consent, including secondary use of information, is obtained in the 'Retinoblastoma National Registry' study.
Key exclusion criteria
Subjects who fulfil any of the following criteria will be excluded from the study
1) Extraocular recurrence cases.
2) Cases with obvious extraocular lesions or distant metastases, as evidenced by symptoms, imaging studies, etc.
3) Cases of second primary malignancies (including third and subsequent malignancies).
4) Other participants deemed inappropriate by the principal investigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shigenobu |
| Middle name | |
| Last name | Suzuki |
Organization
National Cancer Center Hospital
Division name
Department of Ophthalmic Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku Tokyo
TEL
03-3542-2511
sgsuzuki@ncc.go.jp
Public contact
Name of contact person
| 1st name | Hiroyoshi |
| Middle name | |
| Last name | Hattori |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Clinical Genetics
Zip code
460-0001
Address
4-1-1 Naka-ku SannoMaru Nagoya
TEL
052-951-1111
Homepage URL
hiroyoshi.hattori@nnh.go.jp
Sponsor or person
Institute
National Cancer Center Japan
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital Research Ethics Review Board
Address
5-1-1 Tsukiji, Chuo-ku Tokyo
Tel
03-3542-2511
irst@ml.res.ncc.go.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
| 2024 | Year | 05 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim is to observe the various difficulties that retinoblastoma patients face in both disease treatment and growth and development to identify factors significantly associated with family psychological, social and economic anxiety and burden, and leading to supportive and palliative care needed in the treatment of retinoblastoma.
In addition to obtaining clinical and laboratory information on the diagnosis, treatment and follow-up of participants in the clinical research registry from the 'Retinoblastoma National Registry' (a multi-institutional prospective registry study), in order to analyse factors affecting family anxiety, this research development will use the Electric Patient Reported Outcome Measures (ePROMs, hereafter RB-ePRO), as well as patient family information from the RB-ePRO, and information on the practice systems of the facilities participating in the clinical study, will be collected prospectively and analysed in an integrated manner using information from the two EDCs.
Management information
Registered date
| 2024 | Year | 05 | Month | 29 | Day |
Last modified on
| 2025 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062090
