UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Survivorship care for patients with cancer after TrEatment completion in the Asia-Pacific Region: An international service-mapping study (The STEP Study)
Title of the study (Brief title)	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	Hiroko Komatsu
Organization	Keio University
Division name	Faculty of Nursing and Medical Care
Address	35 Shinanomachi, Shinjukuku, Tokyo, 1608582 Japan
TEL	03-5363-3733
Email	hkomatsu@sfc.keio.ac.jp

Public contact
Name of contact person	Kaori Yagasaki
Organization	Keio University
Division name	Faculty of Nursing and Medical Care
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://doi.org/10.1186/s12885-017-3733-3
Results
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/icdr_e/ctr_view.cgi?recptno=R000021719