UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019430 |
|---|---|
| Receipt number | R000021719 |
| Scientific Title | Survivorship care for patients with cancer after TrEatment completion in the Asia-Pacific Region: An international service-mapping study (The STEP Study) |
| Date of disclosure of the study information | 2015/10/22 |
| Last modified on | 2018/04/23 10:47:36 |
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Basic information
Public title
Survivorship care for patients with cancer after TrEatment completion in the Asia-Pacific Region: An international service-mapping study (The STEP Study)
Acronym
Survivorship care for patients with cancer after TrEatment completion(The STEP Study)
Scientific Title
Survivorship care for patients with cancer after TrEatment completion in the Asia-Pacific Region: An international service-mapping study (The STEP Study)
Scientific Title:Acronym
Survivorship care for patients with cancer after TrEatment completion(The STEP Study)
Region
| Japan | Asia(except Japan) | Australia |
Condition
Condition
cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Breast surgery |
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish attitudes, confidence levels, and survivorship care practices of cancer care health professionals in relation to post-treatment survivorship care for patients with cancer.
To examine cancer care health professionals'perspectives of any individual, organisational, and professional factors that influence the provision of survivorship care.
To assess survivorship care needs from the perspectives of patients with cancer.
Basic objectives2
Others
Basic objectives -Others
investigation
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Attitudes, confidence levels, and survivorship care practices of cancer care health professionals in relation to post-treatment survivorship care for patients with cancer.
Cancer care health professionals' perspectives of any individual, organisational, and professional factors that influence the provision of survivorship care.
Survivorship care needs from the perspectives of patients with cancer.
Key secondary outcomes
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
A.health professionals
Age >18 years,
Health professionals (medical officers, nurses, and allied health professionals),
Over 50% of their time spent on caring for patients with cancer in their clinical practice.
B.Patient survey
Age >18 years,
Patients with a definitive cancer diagnosis,
Completed 1st line treatment for their cancer (as determined by their oncologist/treating clinician).
Key exclusion criteria
B.Patient survey
Patients with cognitive impairment that prevent them from participating in the survey,
Patients who are at their end of life,
Patients who do not understand the language to complete the survey.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroko Komatsu |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
Address
35 Shinanomachi, Shinjukuku, Tokyo, 1608582 Japan
TEL
03-5363-3733
hkomatsu@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Yagasaki |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
Address
35 Shinanomachi, Shinjukuku, Tokyo 1608582 Japan
TEL
03-5363-2157
Homepage URL
yagasaki@sfc.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Survivorship care for patients with cancer after TrEatment completion in the Asia-Pacific Region: An international service-mapping study (The STEP Study)
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1186/s12885-017-3733-3
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
| 2015 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 30 | Day |
Other
Other related information
Design:cross-sectional study
Item:Attitudes, confidence levels, and survivorship care practices of cancer care health professionals.
Cancer care health professionals' perspectives of any individual, organisational, and professional factors that influence the provision of survivorship care.
Survivorship care needs from the perspectives of patients with cancer.
Management information
Registered date
| 2015 | Year | 10 | Month | 21 | Day |
Last modified on
| 2018 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021719
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
