UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034560 |
|---|---|
| Receipt number | R000039399 |
| Scientific Title | A prospective observational study to investigate the effect of rehabilitation for cancer patients in palliative care units in Japan: a pilot-feasibility study |
| Date of disclosure of the study information | 2018/10/18 |
| Last modified on | 2019/11/18 19:34:31 |
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Basic information
Public title
A prospective observational study to investigate the effect of rehabilitation for cancer patients in palliative care units in Japan: a pilot-feasibility study
Acronym
A prospective observational study to investigate the effect of rehabilitation for cancer patients in palliative care units in Japan: a pilot-feasibility study
Scientific Title
A prospective observational study to investigate the effect of rehabilitation for cancer patients in palliative care units in Japan: a pilot-feasibility study
Scientific Title:Acronym
A prospective observational study to investigate the effect of rehabilitation for cancer patients in palliative care units in Japan: a pilot-feasibility study
Region
| Japan |
Condition
Condition
Terminal stage cancer
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary aim of this study is to determine whether it is feasible to conduct an international study of the evaluation of the effectiveness of rehabilitation for terminally ill cancer patients.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of patients whose mBI can be evaluated at 3 weeks from baseline in each country and in each site
Key secondary outcomes
1) Patient accrual per month in each country and in each site
2) Proportion of patients whose measurements can be evaluated at baseline in each country and in each site
3) Proportion of patients whose measurements can be evaluated at 1/2/3 weeks from baseline in each country and in each site
4) Proportion of patients whose clinical outcomes can be evaluated at 30 days follow-up in each country and in each site
5) Proportion of mortality at 30 days follow-up in each country and in each site
6) Average days from admission to referral rehabilitation in each country and in each site
7) Contents of rehabilitation
8) Change of mBI total score and sub 10 scores from baseline to 3 weeks or discharge or withdrawal
9) Change of PPS from baseline to 3 weeks or discharge or withdrawal
10) Change of ECOG PS from baseline to 3 weeks or discharge or withdrawal
11) Differences of change of mBI, PPS and ECOG PS from baseline to 3 weeks or discharge or withdrawal between patients who received rehabilitation and patients who did not receive rehabilitation
12) Proportion of adverse events or incidents which are possibly related to rehabilitation
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Life expectancy to be more than 3 weeks (PPI<6.0)
Age>18 years
Cancer diagnosis(no treatment with curative intent)
Hospitalized in PCU(only initial hospitalization of PCU)
ECOG PS=2-4
Key exclusion criteria
Severe symptom burden (any of STAS 3 items (Pain control/Other symptom control/Patient anxiety) = score 4)
Severe cognitive impairment (cannot recognize a therapist)
Respite admission (admission term is about within 1-2 weeks)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Nanako |
| Middle name | |
| Last name | Nishiyama |
Organization
Ashiya Municipal Hospital
Division name
Rehabilitation
Zip code
6598502
Address
39-1, Asahigaoka-cho Ashiya, Hyogo
TEL
0797-31-2156
nishiyama-nnk@umin.org
Public contact
Name of contact person
| 1st name | Nanako |
| Middle name | |
| Last name | Nishiyama |
Organization
Ashiya Municipal Hospital
Division name
Rehabilitation
Zip code
6598502
Address
39-1, Asahigaoka-cho Ashiya, Hyogo
TEL
0797-31-2156
Homepage URL
nishiyama-nnk@umin.org
Sponsor or person
Institute
Ashiya Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Policy-based medical services foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ashiya municipal hospital
Address
39-1, Asahigaoka-cho Ashiya, Hyogo
Tel
0797312156
nishiyama-nnk@umin.org
Secondary IDs
Secondary IDs
YES
Study ID_1
JORTC-RHB01
Org. issuing International ID_1
JORTC
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
市立芦屋病院（兵庫県）
ガラシア病院（大阪府）
JCHO東京新宿メディカルセンター（東京都）
埼玉医科大学附属病院（埼玉県）
相良病院（鹿児島県）
甲南病院（兵庫県）
大阪赤十字病院（大阪府）
薬師山病院（京都府）
市立岸和田市民病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 18 | 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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Study design: Procpective, observational study
Management information
Registered date
| 2018 | Year | 10 | Month | 18 | Day |
Last modified on
| 2019 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039399
