UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037298 |
|---|---|
| Receipt number | R000042525 |
| Scientific Title | A study to confirm the efficacy of specialized rehabilitation for cancer patients in palliative care units ; A multi-center randomized controlled trial |
| Date of disclosure of the study information | 2019/07/07 |
| Last modified on | 2024/01/09 12:14:29 |
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Basic information
Public title
A study to confirm the efficacy of specialized rehabilitation for cancer patients in palliative care units
; A multi-center randomized controlled trial
Acronym
A study to confirm the efficacy of specialized rehabilitation for cancer patients in palliative care units
; A multi-center randomized controlled trial
Scientific Title
A study to confirm the efficacy of specialized rehabilitation for cancer patients in palliative care units
; A multi-center randomized controlled trial
Scientific Title:Acronym
A study to confirm the efficacy of specialized rehabilitation for cancer patients in palliative care units
; A multi-center randomized controlled trial
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To Evaluate the effectiveness of Op-reha and usual rehabilitation.
And then,
To assess the efficacy of usual rehabilitation quantitatively compared with usual care, in which the palliative care units have no available rehabilitation specialists.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in total score of modified Barthel Index (mBI)from baseline after 3 weeks
Key secondary outcomes
1) Change in total score of mBI from baseline after 2 weeks/ 1 week
2)Change in each sub item score of mBI from baseline after 3 weeks/ 2 weeks/ 1 week
3) Longitudinal change in total and each sub item score of mBI in baseline, after 1 week, after 2 weeks and after 3 weeks
4) Proportion of patients who declined 10 points or more in total score of mBI from baseline after 1 week/ 2 weeks/ 3 weeks
5) Change in each domain score of EORTC QLQ-C15-PAL from baseline after 3 weeks/ 2 weeks/ 1 week
6) Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
specialized rehabilitation following the Op-reha guide provided by rehabilitation therapist (Op-reha group)
Interventions/Control_2
usual rehabilitation provided by specialized rehabilitation therapist (Usual rehab group)
Interventions/Control_3
Usual care without specialized rehabilitation
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Hospitalized in PCU (only initial hospitalization of PCU)
2) Patients who are 20 years old or more at the time of the informed consent.
3) Clinical cancer diagnosis
4) No treatment with curative intent(treatment is surgery, chemotherapy and Radiation therapy)
5) Eastern Cooperative Oncology Group Performance Status= 2-3
6) Life expectancy to be 3 weeks or more (Palliative Prognostic Index or less 6)
7) Starting rehabilitation within 1 week after hospitalization of PCU (RCT group)
8) Patients who agree to participate in the study with the written informed consent
Key exclusion criteria
1) Severe symptom burden (any of STAS 3 items (Pain control/Other symptom control/Patient anxiety) = score 4)
2) Respite admission (admission term is about within 1-2 weeks)
3) Road limited due to impending bone fractur
4)Nerve block anesthesia or Percutaneous vertebroplasty (cement composition)
5) The physicians or rehabilitation therapists in charge judge it difficult for their patients to participate in the program
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | Nanako |
| Middle name | |
| Last name | Nishiyama |
Organization
Non-Profit Organization Japanese Organisation for Research and Treatment of Cancer (JORTC)
Division name
Department of Clinical research
Zip code
116-0013
Address
302,2-54-6, Nishinippori, Arakawa-ku, Tokyo, JAPAN
TEL
03-5604-9850
nishiyama-nnk@umin.org
Public contact
Name of contact person
| 1st name | Nanako |
| Middle name | |
| Last name | Nishiyama |
Organization
Non-Profit Organization Japanese Organisation for Research and Treatment of Cancer (JORTC)
Division name
Department of Clinical research
Zip code
116-0013
Address
302,2-54-6, Nishinippori, Arakawa-ku, Tokyo, JAPAN
TEL
03-5604-9850
Homepage URL
nishiyama-nnk@umin.org
Sponsor or person
Institute
Non-Profit Organization Japanese Organisation for Research and Treatment of Cancer (JORTC)
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Osaka National Hospital
Address
2-1-14 Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan
Tel
06-6942-1331
408-chiken@mail.hosp.go.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
市立芦屋病院（兵庫県）
JCHO東京新宿メディカルセンター（東京都）
甲南医療センター（兵庫県）0
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）
東北大学病院（宮城県）
がん・感染症センター都立駒込病院（東京都）
横浜南共済病院（神奈川県）
国立がん研究センター東病院（千葉県）
済生会神奈川県病院（神奈川）
男山病院（京都府）
南部病院（沖縄県）
沖縄病院（沖縄県）
市立東大阪医療センター（大阪府）
新潟県立がんセンター新潟病院（新潟）
富山赤十字病院（富山県）
HITO病院（愛媛県）
佐賀県医療センター好生館（佐賀県）
筑波メディカルセンター病院（茨城県）
仙台オープン病院（宮城県）
TMGあさか医療センター（埼玉県）
京都医療センター（京都府）
出島病院（長崎県）
廿日市記念病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 07 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042525
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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