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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019430
Receipt No. 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

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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
Email 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
Email yagasaki@sfc.keio.ac.jp

Sponsor
Institute Keio University
Institute
Department

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
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 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
URL(English) https://upload.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


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