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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019284
Receipt No. 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 2019/04/15

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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
Email 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
Email akurita@yachts.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Email 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 No longer recruiting
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
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 08 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022297

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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