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
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
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
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
