UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000048535
Receipt No. R000048901
Scientific Title Physician-Patient Communication: Assessing physician strategies for informing children and adolescents about their cancer diagnosis and the risk of gonadal dysfunction.
Date of disclosure of the study information 2022/08/02
Last modified on 2022/08/01

* 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 Physician-Patient Communication: Assessing physician strategies for informing children and adolescents about their cancer diagnosis and the risk of gonadal dysfunction.
Acronym Comparison of information provision for pediatric/adolescent cancer patients between Japan and US
Scientific Title Physician-Patient Communication: Assessing physician strategies for informing children and adolescents about their cancer diagnosis and the risk of gonadal dysfunction.
Scientific Title:Acronym Comparison of information provision for pediatric/adolescent cancer patients between Japan and US
Region
Japan North America

Condition
Condition Pediatric cancer
Classification by specialty
Hematology and clinical oncology Obsterics and gynecology Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Our aim is to know whether the doctor "notifies the cancer diagnosis" to pediatric and adolescent cancer patients, and at that time of cancer diagnosis, "explains the risk of hypogonadism and future infertility due to cancer treatment" by conducting a survey on and comparing the results between Japan and the United States. We will find out the advantages and disadvantages of each other and contribute to improving the QOL of pediatric and adolescent cancer patients.
Basic objectives2 Others
Basic objectives -Others Understanding the current situation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1)Evaluate the current status of notifications by three age groups: elementary school lower grades (pre-puberty), elementary school middle to upper grades (adolescent onset), and junior high school to high school (adolescent)
(2)Evaluate affected factors (patient age, parents' wishes, patient prognosis) when deciding whether to notify pediatric and adolescent cancer patients
(3)For each of the above three age groups, evaluate "doctor's thoughts" as to whether or not you think that you should make a cancer notification as a doctor.
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria Physicians involved in pediatric medicine
Key exclusion criteria Excludes non-physicians.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Nao
Middle name
Last name Suzuki
Organization St.Marianna University school of medicine
Division name Department of obstetrics and gynecology
Zip code 216-8511
Address 2-16-1 Sugar Miyamae-ku Kawasaki Kanagawa
TEL 044-977-8111
Email nao@marianna-u.ac.jp

Public contact
Name of contact person
1st name Yuriko
Middle name
Last name Iwahata
Organization St.Marianna University school of medicine
Division name Department of obstetrics and gynecology
Zip code 216-8511
Address 2-16-1 Sugar Miyamae-ku Kawasaki Kanagawa
TEL 044-977-8111
Homepage URL
Email yuriko.iwahata@marianna-u.ac.jp

Sponsor
Institute St.Marianna University school of medicine
Institute
Department

Funding Source
Organization St.Marianna University school of medicine
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 St.Marianna University school of medicine
Address 2-16-1 Sugar Miyamae-ku Kawasaki Kanagawa
Tel 044-977-8111
Email yuriko.iwahata@marianna-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 08 Month 02 Day

Related information
URL releasing protocol It has not been published
Publication of results Unpublished

Result
URL related to results and publications it has not been published
Number of participants that the trial has enrolled 296
Results now being analyzed
Results date posted
2022 Year 08 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics now been analyzed
Participant flow now been analyzed
Adverse events None
Outcome measures now been analyzed
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
2019 Year 04 Month 01 Day
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2021 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Historical analysis

Management information
Registered date
2022 Year 08 Month 01 Day
Last modified on
2022 Year 08 Month 01 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048901

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.