UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024499 |
|---|---|
| Receipt number | R000027239 |
| Scientific Title | Pilot study on the effectiveness of the STEP Program: Facilitating postsurgical recovery of esophageal cancer patients through partnership between patients, surgeons, and nurses |
| Date of disclosure of the study information | 2016/10/20 |
| Last modified on | 2024/04/26 09:42:53 |
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Basic information
Public title
Pilot study on the effectiveness of the STEP Program: Facilitating postsurgical recovery of esophageal cancer patients through partnership between patients, surgeons, and nurses
Acronym
STEP Program: Pilot Study
Scientific Title
Pilot study on the effectiveness of the STEP Program: Facilitating postsurgical recovery of esophageal cancer patients through partnership between patients, surgeons, and nurses
Scientific Title:Acronym
STEP Program: Pilot Study
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this quasi-experimental study (comparison between pre- and post intervention) is to evaluate the effectiveness of the STEP Program that aims at facilitating postsurgical recovery of esophageal cancer patients through partnership between patients, family, surgeons, and nurses. This program also aims at supporting patients and their family to live post-discharge lives appropriately, alleviating symptoms, and improving quality of life.
The investigators have conducted 6-month post-surgical feasibility study of the STEP program at a large cancer center hospital. Based upon this feasibility study, we further refined the program and will conduct this pilot study as a first step to disseminate this program nationally.
Basic objectives2
Others
Basic objectives -Others
We will also provide training sessions to participating nurses to improve their patient education and communication skills, and to evaluate the effectiveness of training sessions.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of postsurgical recovery and quality of life of patients (levels 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)
Key secondary outcomes
- Estimated sample size will be calculated that is needed for further large-scale interventional study.
- Training sessions will be provided for nurses who are responsible for the STEP program with the aim of improving skills for patient education and communication. Nurses self-rated skills will be evaluated before and after the training.
- Problems of the current STEP program will be discussed based upon the current study results; improvements for the further large-scale STEP program will be identified.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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, including patient specific goal setting and evaluation. Specifically, this program facilitates patient participants' adequate swallowing, nutrition taking, and physical activity, through structured self-monitoring skills including daily log.
- Intervention timing/frequency: (1) preoperative (during hospitalization), (2) postoperative (during hospitalization), (3) one week after discharge (follow-up by telephone), (4) two weeks after discharge (outpatient), (5) thru (7) 3-, 6-, and 12-month after surgery (outpatient).
- Each nurse counseling session will be approximately 15 to 30 minutes; however, nurses will discuss with patient/family to coordinate time (when and how long) and content (what to discuss/instruct) of counseling. Timing and content of counseling will be recorded and will be shared with patient's surgeon with the aim of coordinated care.
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. Any types of reconstruction
4. 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
50
Research contact person
Name of lead principal investigator
| 1st name | Shigeaki |
| Middle name | |
| Last name | Watanuki |
Organization
National College of Nursing, Japan
Division name
Faculty of Nursing
Zip code
204-8575
Address
1-2-1 Umezono, Kiyose-shi, Tokyo
TEL
042-495-2211
watanukis@adm.ncn.ac.jp
Public contact
Name of contact person
| 1st name | Shigeaki |
| Middle name | |
| Last name | Watanuki |
Organization
National College of Nursing, Japan
Division name
Faculty of Nursing
Zip code
204-8575
Address
1-2-1 Umezono, Kiyose-shi, Tokyo
TEL
042-495-2211
Homepage URL
watanukis@adm.ncn.ac.jp
Sponsor or person
Institute
National College of Nursing, Japan
Institute
Department
Personal name
Funding Source
Organization
Foundation for Promotion of Cancer Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Keiyukai Sapporo Hospital
Keiyukai Dai-Ni Hospital
National Cancer Center Hospital
National Cancer Center Hospital-East
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keiyukai Sapporo Hospital
Address
9 Chome-Minami 1-1, Hondori, Shiroishi-ku, Sapporo, Hokkaido
Tel
011-863-2101
rhoukin@keiyukaisapporo.or.jp
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
社会医療法人 恵佑会札幌病院・恵佑会第二病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 20 | 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
171
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
We are in the process of data cleaning and analysis due to multiple cases that needs data cleaning, fixing errors, fixing missing values, etc.
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 28 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 20 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027239
