UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012353 |
|---|---|
| Receipt number | R000014444 |
| Scientific Title | A Prospective Feasibility Study of Scheduled Screening of Palliative Care Needs and QOL Assessment for Patients with Incurable Advanced Solid Tumor Undergoing Chemotherapy |
| Date of disclosure of the study information | 2013/11/20 |
| Last modified on | 2017/05/24 22:21:48 |
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Basic information
Public title
A Prospective Feasibility Study of Scheduled Screening of Palliative Care Needs and QOL Assessment for Patients with Incurable Advanced Solid Tumor Undergoing Chemotherapy
Acronym
Scheduled Screening of Palliative Care Needs and QOL Assessment For Patients with Advanced Solid Tumor Undergoing Chemotherapy
Scientific Title
A Prospective Feasibility Study of Scheduled Screening of Palliative Care Needs and QOL Assessment for Patients with Incurable Advanced Solid Tumor Undergoing Chemotherapy
Scientific Title:Acronym
Scheduled Screening of Palliative Care Needs and QOL Assessment For Patients with Advanced Solid Tumor Undergoing Chemotherapy
Region
| Japan |
Condition
Condition
Solid tumor
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility of schedules screening of palliative care needs by self-administered questionnaire for the patients with advanced solid tumor undergoing chemotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Completion rate of screening questionnaire
Key secondary outcomes
The trend of questionnaire items, the correlation between items, and quality-adjusted survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Periodical screening questionnaire
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Planned to undergo first-line chemotherapy for incurable advanced solid tumor
2) Based on the comfirmed disease and stage, the patient has been fully informed about the treatment by the physician.
3) Able to complete the screening and QOL questionnaire by him- or her-self.
4) Expected to survive for more than 12 weeks.
5) Written informed consent
Key exclusion criteria
1)Concomitant radiotherapy lasting for more than 4 weeks.
2)Chemotherapy planned with interval of 5 weeks or more.
3)Judged inappropriate for participation to the trial by the physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Shibata |
Organization
Comprehensive Cancer Center, Koseiren Takaoka Hospital
Division name
Medical Oncology
Zip code
Address
5-10 Eirakumachi, Takaoka, Toyama
TEL
0766-21-3930
shibata.kazuhiko@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Shibata |
Organization
Comprehensive Cancer Center, Koseiren Takaoka Hospital
Division name
Medical Oncology
Zip code
Address
5-10 Eirakumachi, Takaoka, Toyama
TEL
0766-21-3930
Homepage URL
shibata.kazuhiko@gmail.com
Sponsor or person
Institute
Comprehensive Cancer Center, Koseiren Takaoka 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 | 11 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | 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
| 2013 | Year | 11 | Month | 19 | Day |
Last modified on
| 2017 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014444
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
