UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025860 |
|---|---|
| Receipt number | R000029732 |
| Scientific Title | Survey of psychosocial needs and resilience in family members with dying cancer patients |
| Date of disclosure of the study information | 2017/01/31 |
| Last modified on | 2021/10/07 19:57:55 |
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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
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
yoshimiz@ncc.go.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029732
