UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051123 |
|---|---|
| Receipt number | R000058145 |
| Scientific Title | Study on the efficacy of digital reminiscence collage for older cancer patients at home and their families |
| Date of disclosure of the study information | 2023/06/26 |
| Last modified on | 2024/11/20 16:48:27 |
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Basic information
Public title
Study on the efficacy of digital reminiscence collage for older cancer patients at home and their families
Acronym
Study on the efficacy of digital reminiscence collage for older cancer patients at home and their families
Scientific Title
Study on the efficacy of digital reminiscence collage for older cancer patients at home and their families
Scientific Title:Acronym
Study on the efficacy of digital reminiscence collage for older cancer patients at home and their families
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To conduct a digital reminiscence collage for older cancer patients at home with their families, and to clarify the effectiveness of the collage on the psychosocial aspects of the patients, the quality of life of their families, and the patient-family relationship.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-efficacy scale scores of older cancer patients at completion of the intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Digital reminiscence collage group
Interventions/Control_2
control group that completes the survey form
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients
1) Patients with cancer who are being cared for at home.
2) Patients 65 years of age or older.
3) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 2.
4) Patients who can obtain written consent for participation in this study.
Family members
1) The caregiver of the older cancer patient who has been involved in the patient's care for the longest period of time.
2) Persons who are at least 18 years of age at the time consent is obtained.
3) Persons who can obtain written consent for participation in this study.
Key exclusion criteria
Patients
1) Patients undergoing aggressive anticancer treatment
2) Patients whose general condition is so serious that they cannot tolerate the completion of the digital reminiscence collage.
3) Patients who have difficulty understanding the purpose of the study and the questionnaire due to severe dementia, delirium, or other disorders of consciousness.
Family members
1) Persons who are deemed inappropriate to conduct this study by the principal investigator.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Okamura |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5450
hokamura@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Okamura |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5450
Homepage URL
hokamura@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
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
Clinical Research Ethics Committee of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
082-257-1551
iryo-sinsa@office.hiroshima-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
| 2023 | Year | 06 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 05 | Month | 22 | Day |
Last modified on
| 2024 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058145
