UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of Self-Management Support Program for Elderly Patients with Lung Cancer Who Are Receiving Molecularly Targeted Therapy with Oral Agents : Pilot Study
Acronym	Evaluation of Self-Management Support Program for Elderly Patients with Lung Cancer Who Are Receiving Molecularly Targeted Therapy with Oral Agents : Pilot Study
Scientific Title	Evaluation of Self-Management Support Program for Elderly Patients with Lung Cancer Who Are Receiving Molecularly Targeted Therapy with Oral Agents : Pilot Study
Scientific Title:Acronym	Evaluation of Self-Management Support Program for Elderly Patients with Lung Cancer Who Are Receiving Molecularly Targeted Therapy with Oral Agents : Pilot Study
Region	Japan

Condition
Condition	Lung Cancer
Classification by specialty	Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is evaluate the Self-Management Support Program for Elderly Patients with Lung Cancer Who Are Receiving Molecularly Targeted Therapy with Oral Agents regarding the effectiveness.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QOL:SF-8(SF8 Health Survey)
Key secondary outcomes	Anxious/Depression : HADS(Hospital Anxiety and Depression Scale) Social support: Ask about the presence of "emotional support", "tool support", "information support" and "evaluative support. Symptoms: PRO-CTCAE(version 1.0)(Patient-Reported Outcome Common Terminology Criteria for Adverse Events)

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	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	The program aimed to develop and refine a self-management support program to maintain the QOL of elderly patients with lung cancer. The elements constituting the program are: 1) helping the patient maintain his/her lifestyle in accordance with their own values 2) providing information that is tailored to each patient 3) assessing the daily living situation of each patient, and 4) coordinating the relationships between patients and caregivers. The program was executed three times within a period of two month after the start of therapy. "In hospitalization for introduction of treatment or during outpatient visit within 2 weeks from start of treatment", second intervention as "outpatient visit around 3-4 weeks after start of treatment", and third intervention as "outpatient visit around 2 months after start of treatment"
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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Lung cancer patients over 75 years old. Treatment with molecular target drugs will be started and will be continued in the outpatient department. Includes both cases of initial treatment or starting with regimen changes.
Key exclusion criteria	Patients with severe physical or mental symptoms. Difficult to communicate due to a decline in cognitive function.
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Kumi Middle name Last name Suzuki
Organization	Osaka Medical College
Division name	Faculty of Nursing
Zip code	569-0095
Address	7-6, Hatchonishi-machi, Takatsuki City, Osaka
TEL	072-683-1221
Email	kumisuzuki@osaka-med.ac.jp

Public contact
Name of contact person	1st name Akiko Middle name Last name Fukawa
Organization	Osaka Medical College
Division name	Faculty of Nursing
Zip code	569-0095
Address	7-6, Hatchonishi-machi, Takatsuki City, Osaka
TEL	072-684-6217
Homepage URL
Email	fon163@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Osaka Medical College Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Osaka Medical College
Address	7-6, Hatchonishi-machi, Takatsuki City, Osaka
Tel	072-363-1221
Email	rinri@art.osaka-med.ac.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	大阪医科大学附属病院

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 23 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	Preinitiation
Date of protocol fixation	2019 Year 09 Month 17 Day
Date of IRB	2019 Year 11 Month 14 Day
Anticipated trial start date	2019 Year 12 Month 23 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 12 Month 06 Day
Last modified on	2019 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044255