UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038812
Receipt number R000044255
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
Date of disclosure of the study information 2019/12/23
Last modified on 2019/12/06 16:54:07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Osaka Medical College

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044255


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name