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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037298
Receipt No. 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 2021/07/08

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
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
Address 302,2-54-6, Nishinippori, Arakawa-ku, Tokyo, JAPAN
TEL 03-5604-9850
Email nishiyama-nnk@umin.org

Public contact
Name of contact person
1st name
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
Address 302,2-54-6, Nishinippori, Arakawa-ku, Tokyo, JAPAN
TEL 03-5604-9850
Homepage URL
Email nishiyama-nnk@umin.org

Sponsor
Institute Non-Profit Organization Japanese Organisation for Research and Treatment of Cancer (JORTC)
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Address
Tel
Email

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)
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)
宇治徳洲会病院(京都府)
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)

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
Anticipated trial start date
2019 Year 07 Month 08 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 07 Day
Last modified on
2021 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042525


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