UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019284 |
|---|---|
| Receipt number | R000022297 |
| Scientific Title | Effects of looking back on family life between elderly patient with cancer and family, named Memory Shearing care, on end of life. |
| Date of disclosure of the study information | 2015/10/09 |
| Last modified on | 2024/04/15 09:16:57 |
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Basic information
Public title
Effects of looking back on family life between elderly patient with cancer and family, named Memory Shearing care, on end of life.
Acronym
Effects of looking back on family life between elderly patient with cancer and family, named Memory Shearing care, on end of life.
Scientific Title
Effects of looking back on family life between elderly patient with cancer and family, named Memory Shearing care, on end of life.
Scientific Title:Acronym
Effects of looking back on family life between elderly patient with cancer and family, named Memory Shearing care, on end of life.
Region
| Japan |
Condition
Condition
elderly patient with cancer and family
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of Memory Shearing care (MS) as a new type of end of life care on elderly patient with cancer and family.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FACIT-SP12
SEIQoL-DW
Qualitative data by the semistructured interview
Around three days before and after intervention,and around one month after intervention
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
| Maneuver |
Interventions/Control_1
Memory Sharing
Nursing care of looking back on family life .
Three times every about one week.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cancer patient 75 years or older and family
Key exclusion criteria
･ Cancer is not announced to patient or family.
･ Mental and physical problem
･ Severe dementia
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | HONDA |
Organization
Seirei Christopher University
Division name
School of Nursing
Zip code
433-8558
Address
3453 Mikatagahara-machi Kita-ku Hamamatsu city Shizuoka Pref. JAPAN.
TEL
053-439-1400
akiko-ho@seirei.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | KURITA |
Organization
Yamagata Prefectural University of Health Science
Division name
Department of Nursing
Zip code
990-2212
Address
260 Kamiyanagi Yamagata City, Yamanaga Pref. JAPAN
TEL
0236866684
Homepage URL
akurita@yachts.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
The Yuumi Memorial Foundation for Home Health Care
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
Tokyo Medical and Dental University
Address
1-5-45 Yushima Bunkyo-ku Tokyo, JAPAN
Tel
0236866684
akurita@yachts.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
あおぞら診療所新松戸(千葉県)、緩和ケア診療所いっぽ(群馬県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 09 | 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
5
Results
We performed Memory Sharing on 4 out of 5 subjects. Among them, it was one set that carried out all interventions and data collection.
Currently, we are preparing to post to overseas journals
Results date posted
| 2019 | Year | 04 | Month | 15 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Data collection and analysis were delayed.
Date of the first journal publication of results
Baseline Characteristics
We targeted cancer patients over 75 years old and their families who were home-based.
Participant flow
We received 22 pairs by clinic, and 5 gave consent . Intervention "Memory Sharing" was performed on 4 out of 5 sets. Were collected data before the intervention, one week after, and one month after . All interventions and surveys were conducted on one pair because of the deterioration of the patient's condition.
Adverse events
No adverse events.
Outcome measures
SEIQoL-DW
FACIT-SP-12
Semi structure interview
Plan to share IPD
No
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 13 | Day |
Other
Other related information
The analysis has been completed and the submission is being prepared.
Management information
Registered date
| 2015 | Year | 10 | Month | 08 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022297
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| Research case data | |
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