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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011416
Receipt No. R000013309
Scientific Title Feasibility study of the STEP Program: Facilitating postsurgical recovery of thoracic esophageal cancer patients through partnership between patients, surgeons, and nurses
Date of disclosure of the study information 2013/08/09
Last modified on 2016/08/17

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Basic information
Public title Feasibility study of the STEP Program: Facilitating postsurgical recovery of thoracic esophageal cancer patients through partnership between patients, surgeons, and nurses
Acronym STEP Program
Scientific Title Feasibility study of the STEP Program: Facilitating postsurgical recovery of thoracic esophageal cancer patients through partnership between patients, surgeons, and nurses
Scientific Title:Acronym STEP Program
Region
Japan

Condition
Condition Thoracic esophageal cancer
Classification by specialty
Gastrointestinal surgery Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the feasibility of the STEP Program, including development and evaluation of a provisional set of indicators and measures of the study. The STEP Program aims at facilitating postsurgical recovery of thoracic esophageal cancer patients through partnership between patients, surgeons, and nurses.
Basic objectives2 Others
Basic objectives -Others To evaluate the feasibility of the STEP Program intervention, to develop and evaluate a provisional set of indicators and measures of the study, and to determine patients' postsurgical recovery and quality of life.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Feasibility of the STEP Program:
Patients' participation rate, attrition rate, response rate; the level of understanding about patient education, adherence rate of the program, the efficacy of the program, the level of willingness to continue participation
Key secondary outcomes 2. Development and evaluation of a set of provisional indicators and measures of the study:
Evaluation of postsurgical recovery and quality of life (e.g., level of daily physical activity, quality of life, body mass index, etc. before surgery, before discharge from hospital, 2 weeks after discharge, 3 months after surgery, 6 months after surgery)

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 Educational,Counseling,Training
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Provide educational and counseling program for the patient participants with the aim of their health behavior maintenance and modification. Specifically, this program facilitates patient participants' adequate swallowing, nutrition taking, and physical activity through structured self-monitoring skills including daily log.
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 1. Esophageal cancer (indication of surgical resection)
2. Radical surgery (including open abdominal, open thoracic, video-assisted or thoraco-/laparo-scopic)
3. With or without preoperative or postoperative chemotherapy or radiotherapy (i.e., neoadjuvant or adjuvant therapy)
Key exclusion criteria 1. Have permanent tracheotomy
2. Two-step esophagectomy and reconstruction
3. Inappropriate to invite for study participation, deemed by the patients' surgeon in charge
Target sample size 30

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 Shinano-machi Shinjuku-ku, Tokyo
TEL 03-5363-3733
Email hkomatsu@sfc.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideo Uesugi
Organization National Cancer Center Hospital East
Division name Department of Nursing
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba-ken
TEL 04-7133-1111
Homepage URL
Email huesugi@east.ncc.go.jp

Sponsor
Institute Keio University, Faculty of Nursing and Medical Care
Institute
Department

Funding Source
Organization Ministry of Health, Labour, and Welfare: Health and Labour Sciences Research Grants (Third Term Comprehensive Control Research for Cancer)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 国立がん研究センター東病院(千葉県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 09 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 Completed
Date of protocol fixation
2013 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 22 Day
Last follow-up date
2014 Year 11 Month 20 Day
Date of closure to data entry
2015 Year 01 Month 10 Day
Date trial data considered complete
2015 Year 01 Month 10 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 08 Day
Last modified on
2016 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013309

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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