UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047466 |
|---|---|
| Receipt number | R000054126 |
| Scientific Title | Cross-sectional research on QOL of hematopoietic stem cell transplant patient families |
| Date of disclosure of the study information | 2022/04/18 |
| Last modified on | 2024/11/30 14:15:32 |
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Basic information
Public title
Cross-sectional research on QOL of hematopoietic stem cell transplant patient families
Acronym
Cross-sectional research on QOL of hematopoietic stem cell transplant patient families
Scientific Title
Cross-sectional research on QOL of hematopoietic stem cell transplant patient families
Scientific Title:Acronym
Cross-sectional research on QOL of hematopoietic stem cell transplant patient families
Region
| Japan |
Condition
Condition
Family of patients undergoing hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the factors related to QOL in the family of patients who received hematopoietic stem cell transplantation.
Basic objectives2
Others
Basic objectives -Others
Establish a support system for the patient's family
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Caregiver Quality of Life Index-Cancer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Questionnaire survey
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
Received hematopoietic stem cell transplantation at our hospital from April 2008 to March 2022, and performed "Post-transplant LTFU & Vaccination Outpatient" or "Hematology Doctor's Outpatient" at least once from February 2022 to March 2023. Family of patients who have undergone an outpatient follow-up
Key exclusion criteria
Patient families that the attending physician deems inappropriate for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | naoyuki |
| Middle name | |
| Last name | uchida |
Organization
Toranomon Hospital
Division name
Hematology
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo
TEL
0335881111
nuchida@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | madoka |
| Middle name | |
| Last name | narita |
Organization
Toranomon Hospital
Division name
Hematology
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo
TEL
0335881111
Homepage URL
toraco@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Cancer Nursing -JSCN
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toranomon Hospital
Address
2-2-2 Toranomon, Minato-ku, Tokyo
Tel
0335881111
chiken-jim@toranomon.gr.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 | 04 | Month | 18 | Day |
Related information
URL releasing protocol
No
Publication of results
Unpublished
Result
URL related to results and publications
No
Number of participants that the trial has enrolled
100
Results
Exploring support systems for families of patients within five years after transplantation has been suggested as one approach to improving their quality of life (QOL). It is also considered necessary to strengthen proactive communication from healthcare providers and enhance the guidance on consultation services.
Results date posted
| 2024 | Year | 11 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The majority of family members were in their 50s (35%), and 72% were women. Many continued working in the same job as at the time of transplantation (45%) and had someone to consult with (90%). The relationship to the patient was predominantly a spouse/partner (81%), and most accompanied the patient to outpatient visits nearly every time (96%). A significant proportion were families of patients within 5 years post-transplantation (65%).
Participant flow
No
Adverse events
No
Outcome measures
QOL
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 12 | Day |
Last modified on
| 2024 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054126
