UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011416 |
|---|---|
| Receipt number | 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 11:35:25 |
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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
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
huesugi@east.ncc.go.jp
Sponsor or person
Institute
Keio University, Faculty of Nursing and Medical Care
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013309
