UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026996 |
|---|---|
| Receipt number | 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 | 2020/05/01 14:57:02 |
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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 | Tamami |
| Middle name | |
| Last name | Hamada |
Organization
Asahikawa Medical University
Division name
Department of Nursing
Zip code
078-8510
Address
2-1-1-1 Midorigaoka higashi, Asahikawa, Hokkaido 078-8510, Japan
TEL
0166-68-2915
thamada@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Tamami |
| Middle name | |
| Last name | Hamada |
Organization
Asahikawa Medical University
Division name
Department of Nursing
Zip code
078-8510
Address
2-1-1-1 Midorigaoka higashi, Asahikawa, Hokkaido 078-8510, Japan
TEL
0166-68-2915
Homepage URL
thamada@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
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
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1 Midorigaoka higashi, Asahikawa, Hokkaido 078-8510, Japan
Tel
0166-68-2297
rs-kk.g@asahikawa-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
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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 14 | Day |
Last modified on
| 2020 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030953
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