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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026996
Receipt No. R000030953
Scientific Title Life support program for symptom cluster reduction in patients with advanced non-small cell lung cancers (NSCLCs) - A feasibility study
Date of disclosure of the study information 2017/06/30
Last modified on 2018/10/25

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Basic information
Public title Life support program for symptom cluster reduction in patients with advanced non-small cell lung cancers (NSCLCs) - A feasibility study
Acronym Life support program for symptom cluster reduction in patients with advanced non-small cell lung cancers (NSCLCs) - A feasibility study
Scientific Title Life support program for symptom cluster reduction in patients with advanced non-small cell lung cancers (NSCLCs) - A feasibility study
Scientific Title:Acronym Life support program for symptom cluster reduction in patients with advanced non-small cell lung cancers (NSCLCs) - A feasibility study
Region
Japan

Condition
Condition Advanced (Stage IIIB or IV) or
Recurrence non-small cell lung cancers
Classification by specialty
Pneumology Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Examine the feasibility of a symptom cluster reduction life support program for patients with advanced non-small cell lung cancers undergoing standard therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Symptom severity of each Symptom cluster at the 4 time-points (baseline, 1, 2, and 10 weeks after intervention)

2. Dropout rate of participating patients at the 4 time-points (baseline, 1, 2, and 10 weeks after intervention), with reasons for dropout based on a qualitative analysis of phone communications.
Key secondary outcomes 1.Interference with daily life due to symptoms at the 4 time-points (baseline, 1, 2, and 10 weeks after intervention)

2. QOL (EORTC-QLQC30+LC13) at the 4 time-points (baseline, 1, 2, and 10 weeks after intervention)

3.No. of emergency department visits (baseline, beginning of intervention to 10 weeks)

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Patients will be given cognitive behavioral intervention to support symptom management, led by nurses focusing on the Pain cluster and Fatigue / anorexia cluster: face-to-face (once at the first occasion); then by phone (5 times) over 10 weeks.
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients diagnosed with primary lung cancer, non-small cell lung cancers that are unresectable, at advanced stages (IIIB or IV), or due to recurrence after the second line of standard therapies.

2. Patients who were not diagnosed with other cancers during the previous one year at the time of giving consent.

3. Patients evaluated by physicians as having no un-endurable physical and/or mental pain, and with no cognitive impairment at the time of referral.

4. Patients signing the consent form by their own decision after receiving a detailed explanation about the study participation in writing and orally.

5. PS 0-1

6. Patients with symptoms rated as 1 or higher either in: the tiredness/lack of appetite clusters (loss of appetite, drowsiness, tiredness (fatigue), altered sense of taste, dry mouth), or in the pain clusters (pain, anxiety, sadness), as evaluated at the baseline.
Key exclusion criteria 1. Patients evaluated by physicians to have difficulty in understanding and answering questions due to hearing or cognitive impairment.

2. Patients evaluated to have un-endurable physical and/or mental pain at the time of referral or when deciding on the study participation.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tamami Hamada
Organization Asahikawa Medical University
Division name Department of Nursing
Zip code
Address 2-1-1-1 Midorigaoka higashi, Asahikawa, Hokkaido 078-8510, Japan
TEL 0166-68-2915
Email thamada@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tamami Hamada
Organization Asahikawa Medical University
Division name Department of Nursing
Zip code
Address 2-1-1-1 Midorigaoka higashi, Asahikawa, Hokkaido 078-8510, Japan
TEL 0166-68-2915
Homepage URL
Email thamada@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization MEXT (Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 北海道大学病院(北海道)
Hokkaido University Hospital(Hokkaido, Japan)
聖路加国際病院(東京都)
St.Luke’s International Hospital(Tokyo, Japan)
se

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 30 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 Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 14 Day
Last modified on
2018 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030953

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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