UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030177 |
|---|---|
| Receipt number | R000034469 |
| Scientific Title | Efficacy of spiritual care using SpiPas for advanced cancer patients: A non-randomized control trial |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2023/03/30 10:02:20 |
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Basic information
Public title
Efficacy of spiritual care using SpiPas for advanced cancer patients: A non-randomized control trial
Acronym
Spiritual care using SpiPas with advanced cancer patients
Scientific Title
Efficacy of spiritual care using SpiPas for advanced cancer patients: A non-randomized control trial
Scientific Title:Acronym
Spiritual care using SpiPas with advanced cancer patients
Region
| Japan |
Condition
Condition
Advanced and/or terminally ill cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the efficacy of spiritual care using the spiritual pain assessment sheet (SpiPas) for alleviation of spiritual pain in advanced and/or terminally ill cancer patients with non-randomized confirmatory samples.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp) Japanese Version in Cancer Patients
Key secondary outcomes
1.Hospital Anxiety and Depression Scale(HADS)
2.Complehensive Quality of Life Outcome Inventory (CoQoLo)
3.Japanese version of the M. D. Anderson Symptom Inventory(MDASIJ)
4. Nurses' confidence, knowledge and attitudes towards spiritual care
5. Spiritual pain assessment and care plan (intervention group only)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Spiritual care using SpiPas
Interventions/Control_2
Usual care
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
1. The patient was diagnosed with advanced cancer and described about his diagonosis
2. Age 20 years and older
3. Ability to participate in 30 minutes interviews and questionnaire for twice in two weeks
4. The patient currently experience spiritual pain
5. No evidence of severe cognitive impairment such as dementia or delirium
6. Ability to provide oral and written informed consent
Key exclusion criteria
1.Following the primary physician/nurse's direction the patient is unable to complete the study due to the severity of physical and mental condition
2.Impossible to make linguistic communication
3.The patient currently dose not exrerience spiritual pain
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Tamura |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Human Health Science
Zip code
606-8507
Address
53 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
075-751-3921
tamura.keiko.2u@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Ichihara |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Human Health Science
Zip code
606-8507
Address
53 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
075-751-3921
Homepage URL
ichihara.kaori.62s@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
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
Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address
54 Shogoin Kawaharacho, Sakyoku, Kyot
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2018 | Year | 05 | Month | 01 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 29 | Day |
Last modified on
| 2023 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034469
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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