UMIN-CTR Clinical Trial

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