UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of the STEP Program: Facilitating postsurgical recovery of thoracic esophageal cancer patients through partnership between patients, surgeons, and nurses
Title of the study (Brief title)	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	Hiroko Komatsu
Organization	Keio University
Division name	Faculty of Nursing and Medical Care
Address	35 Shinano-machi Shinjuku-ku, Tokyo
TEL	03-5363-3733
Email	hkomatsu@sfc.keio.ac.jp

Public contact
Name of contact person	Hideo Uesugi
Organization	National Cancer Center Hospital East
Division name	Department of Nursing
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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