UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057105 |
|---|---|
| Receipt number | R000065180 |
| Scientific Title | Development of a Nursing Support Model to Promote Body Image for the Prevention of Frailty in Patients with Hematological Malignancies |
| Date of disclosure of the study information | 2025/02/25 |
| Last modified on | 2026/02/24 09:29:54 |
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Basic information
Public title
Development of a Nursing Support Model to Promote Body Image for the Prevention of Frailty in Patients with Hematological Malignancies
Acronym
Development of a Nursing Support Model to Promote Body Image for the Prevention of Frailty in Patients with Hematological Malignancies
Scientific Title
Development of a Nursing Support Model to Promote Body Image for the Prevention of Frailty in Patients with Hematological Malignancies
Scientific Title:Acronym
Development of a Nursing Support Model to Promote Body Image for the Prevention of Frailty in Patients with Hematological Malignancies
Region
| Japan |
Condition
Condition
Hematological Malignancies
Classification by specialty
| Hematology and clinical oncology | Rehabilitation medicine | Nursing |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the acceptability of a "nursing support model that promotes body image," which encourages frailty prevention behaviors by supporting patients with hematologic malignancies who have undergone high-dose chemotherapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Participation rate, Dropout rate, Compliance rate
Key secondary outcomes
Body Image Assessment Tool scores, physical functions, Risk of falling, number of falls, Qualitative data
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
The body function assessment, rehabilitation suggestions, and individual consultations will be conducted by nurses through the nursing support model.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with hematological malignancies aged 18 years or older
2) Patients who have undergone high-dose chemotherapy, autologous hematopoietic stem cell transplantation, or allogeneic hematopoietic stem cell transplantation as an inpatient and who have completed treatment and are being discharged
3) Must be able to communicate in Japanese and respond to survey questionnaires
4) Must be able to participate in all intervention programs.
Key exclusion criteria
1) Individuals who have relapsed
2) Individuals who have severe or unstable cardiovascular, respiratory, musculoskeletal, neurological or psychiatric disorders that may impair motor function
3) Individuals who have a platelet count of 20,000/microL or less at the time of selection, or who are expected to have a platelet count of 20,000/microL or less after discharge
4) Individuals with a hemoglobin level of 7.5 g/dL or less at the time of selection, or those who are expected to have a hemoglobin level of 7.5 g/dL or less after discharge
5) Individuals who are unsteady on their feet
6) Individuals who have poor dietary intake
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hana |
| Middle name | |
| Last name | Kiyohara |
Organization
University of Hyogo
Division name
Graduate School of Nursing Art and Science
Zip code
673-8588
Address
13-71 Kitaoji-cho, Akashi-city, Hyogo
TEL
078-925-9434
hana_kiyohara@cnas.u-hyogo.ac.jp
Public contact
Name of contact person
| 1st name | Hana |
| Middle name | |
| Last name | Kiyohara |
Organization
University of Hyogo
Division name
Graduate School of Nursing Art and Science
Zip code
673-8588
Address
13-71 Kitaoji-cho, Akashi-city, Hyogo
TEL
078-925-9434
Homepage URL
hana_kiyohara@cnas.u-hyogo.ac.jp
Sponsor or person
Institute
University of Hyogo
Institute
Department
Personal name
Hana Kiyohara
Funding Source
Organization
JSPS KAKENHI Grant Number 21K10805
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka International Cancer Institute
Hyogo Cancer Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, College of Nursing Art and Science and Research Institute of Nursing Care for People and Community, University of Hyogo
Address
13-71 Kitaoji-cho, Akashi-city, Hyogo
Tel
078-925-9434
hana_kiyohara@cnas.u-hyogo.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
大阪国際がんセンター（大阪府）
兵庫県立がんセンター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 02 | Month | 21 | Day |
Last modified on
| 2026 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065180
