UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010913 |
|---|---|
| Receipt number | R000012715 |
| Scientific Title | Supportive care needs in advanced cancer patients receiving rehabilitation interventions. |
| Date of disclosure of the study information | 2013/06/10 |
| Last modified on | 2016/08/17 10:09:05 |
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Basic information
Public title
Supportive care needs in advanced cancer patients receiving rehabilitation interventions.
Acronym
Supportive care needs in advanced cancer patients receiving rehabilitation interventions.
Scientific Title
Supportive care needs in advanced cancer patients receiving rehabilitation interventions.
Scientific Title:Acronym
Supportive care needs in advanced cancer patients receiving rehabilitation interventions.
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Hematology and clinical oncology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the prevalence of the unmet needs among advanced cancer patients and the relation between the unmet needs and distress/activities of daily living.
Basic objectives2
Others
Basic objectives -Others
To assess the prevalence of the unmet needs among advanced cancer patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the prevalence of the unmet needs among cancer patients and the relation between the unmet needs and distress/activities of daily living.
Key secondary outcomes
satisfaction with rehabilitation.
usefulness of rehabilitation for emotional support.
the prevalence of psychological distress.
the prevalence of symptoms.
the relation between the satisfaction and the types of rehabilitation management/classification of cancer rehabilitation/activities of daily living/psychological distress.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with a cancer diagnosis
an age of 20 years or older
well enough to complete the questionnaire
informed of the cancer diagnosis
cancer, thought to have a poor prognosis
participated in a physical examination 5 times or more
Key exclusion criteria
severe mental or cogniitive disorder
an inability to understand the japanese language
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hasegawa Takaaki |
Organization
Gifu municipal hospital
Division name
Department of respiratory and medical oncology
Zip code
Address
7-1 KASHIMA-CHO GIFU-SHI GIFU
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Gifu municipal hospital
Division name
Department of respiratory and medical oncology
Zip code
Address
7-1 KASHIMA-CHO GIFU-SHI GIFU
TEL
Homepage URL
Sponsor or person
Institute
Gifu municipal hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 10 | 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
Main results already published
Date of protocol fixation
| 2013 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We use multiple logistic regression to investigate the relation between the unmet needs and HADS score/FIM, and the relation between the satisfasction or usefulness of rehabilitation for emotional support and HADS score/FIM/unmet needs.
Management information
Registered date
| 2013 | Year | 06 | Month | 09 | Day |
Last modified on
| 2016 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012715
