UMIN-CTR Clinical Trial

Basic information
Public title	Survey of psychosocial needs and resilience in family members with dying cancer patients
Acronym	Survey of resiliece in families with dying cancer patients
Scientific Title	Survey of psychosocial needs and resilience in family members with dying cancer patients
Scientific Title:Acronym	Survey of resiliece in families with dying cancer patients
Region	Japan

Condition
Condition	neoplasm
Classification by specialty	Medicine in general Nursing Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	1)to investigate psychosocial needs in family members with terminal cancer patients 2)to explore the association between resilience and mental status in family members with terminal cancer patients 3)to explore factors influencing their mental well-being
Basic objectives2	Others
Basic objectives -Others	Cross-sectional survey
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Proportion of respondents whose PHQ-9 score are under 10
Key secondary outcomes	Proportion of respondents whose GAD-7 score are under 10

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	family members of patients 1.with advanced cancer 2.who know own disease 3.at palliative care unit and, family members 4.whom patients recognize as primary family caregivers
Key exclusion criteria	1)patients refuse to take part in this study, 2)patitens' age is under 20 3)patients do not stay in PCU over 48h 4)patients have already taken part in this study 5)family members' age is under 20 6)family members who palliative care physicians think is difficult to answer the questionnaires because of their mental status 7)family members who cannot speak Japanese 8)family members refuse to take part in this study
Target sample size	470

Research contact person
Name of lead principal investigator	1st name Mitsunori Middle name Last name Miyashita
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Palliative Nursing
Zip code	980-8575
Address	School of Health Sciences Building D, 2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
TEL	022-717-7924
Email	miya@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Yoichi Middle name Last name Shimizu
Organization	National Cancer Center, Center for Public Health Sciences
Division name	Division of Health Care Research
Zip code	104-0045
Address	5-1-1, Tsukiji-cho, Chuo-ku, Tokyo, 104-0045, Japan
TEL	03-3542-2511
Homepage URL
Email	yoshimiz@ncc.go.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Grant for Research Advancement on Palliative Medicine, Japanese Society for Palliative Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Grant-in-Aid for Young Scientists (B), Grant-in-Aid for Scientific Research, Japan Society for the Promotion of Science

IRB Contact (For public release)
Organization	the institutional review boards of Tohoku University School of Medicine
Address	2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.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	聖路加国際病院（東京都）、国立がん研究センター東病院（千葉）、東北大学病院(宮城県）、ガラシア病院(大阪府）

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.1002/pon.5783
Number of participants that the trial has enrolled	317
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Now analysing
Date of the first journal publication of results	2021 Year 08 Month 07 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 26 Day
Date of IRB	2016 Year 09 Month 28 Day
Anticipated trial start date	2016 Year 12 Month 05 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 05 Month 11 Day
Date trial data considered complete	2018 Year 05 Month 18 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information	We will do this survey with the questionnaire in some palliative care units in Japan. In the questionnaire, we will check family caregivers' psychiatric needs, their perceptions about patients' status and care, resilience, coping strategy, caregiving burden, social support, religious belief, and background information.

Management information
Registered date	2017 Year 01 Month 26 Day
Last modified on	2021 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029732