UMIN-CTR Clinical Trial

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

Thoracic esophageal cancer

Classification by specialty

Gastrointestinal surgery

Nursing

Classification by malignancy

Malignancy

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Keio University, Faculty of Nursing and Medical Care

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立がん研究センター東病院(千葉県)

Date of disclosure of the study information

2013

Year

08

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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