UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of nursing care program to sustain the patients with recurrent lung cancer using "Hope-Design Note"
Title of the study (Brief title)	Development of nursing care program to sustain the patients with recurrent lung cancer using "Hope-Design Note"
Region	Japan

Condition
Condition	patients with recurrent lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to develop a nursing care program that sustains the hope of patients with recurrent lung cancer using "Hope-Design Note" and clarify the effect.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1.The patients can express their hope 2.The patients can find the way of life in their future
Key secondary outcomes	1.Evaluation by hope scale: Herth Hope Index(HHI) 2.Evaluation by QOL scale: European Organization for Research Treatment of Cancer (EORTC QLQ-C30)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Session of nursing care program using "Hope-Design Note" Each session takes 30-60 minutes and we have 2 or 3 sessions. Session intervention is provided by the researcher using "Hope-Design Note". Contents of intervention, the patient fills in the answer to the question of "Hope-Design Note". What to write in the "Hope-Design Note" 1 My family member or close friends and precious things for me 2 What I want to do for my family member or close friends and precious things for me If it is difficult for the patient to write in "Hope-Design Note", the researcher writes instead.
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1 Patient has undergone surgery for lung cancer and received a diagnosis of recurrence 2 Patient can communicate in Japanese 3 Patient and their family know the patient's condition and treatment 4 Patient doesn't have serious cognative disorder and mental disease 5 Patient has physical status to endure examination
Key exclusion criteria	The primary physician estimate that patient cannot participate in the intervention or answer the questionnaire because of his/her physical,mental,or cognitive function.
Target sample size	5

Research contact person
Name of lead principal investigator	Tomoko Yamazaki
Organization	Graduate School of Health Care Sciences, Tokyo Medical and Dental University
Division name	Nursing Course of End-of Life care and Oncology
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL	03-3813-5335
Email	ns140012@tmd.ac.jp

Public contact
Name of contact person	Hisako Sanbe
Organization	Graduate School of Health Care Sciences, Tokyo Medical and Dental University
Division name	Nursing Course of End-of Life care and Oncology
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL	03-3813-7238
Homepage URL
Email	ns140012@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 23 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 13 Day
Anticipated trial start date	2017 Year 09 Month 19 Day
Last follow-up date	2019 Year 01 Month 07 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

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

Management information
Registered date	2017 Year 07 Month 13 Day
Last modified on	2019 Year 01 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032175