UMIN-CTR Clinical Trial

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
Email	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
Email	nishiyama-nnk@umin.org

Sponsor
Institute	Ashiya Municipal Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039399