UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029663 |
|---|---|
| Receipt number | R000033854 |
| Scientific Title | Prospective Cohort Study to investigate factors affecting Health Related Quality of Life and the Effectiveness of Symptoms Monitoring via Computer-based Health Evaluation System (CHES) in Patients with Metastatic solid cancers during chemotherapy |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2021/04/25 11:57:17 |
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Basic information
Public title
Prospective Cohort Study to investigate factors affecting Health Related Quality of Life and the Effectiveness of Symptoms Monitoring via Computer-based Health Evaluation System (CHES) in Patients with Metastatic solid cancers during chemotherapy
Acronym
PROMISE-KOBE Study
Scientific Title
Prospective Cohort Study to investigate factors affecting Health Related Quality of Life and the Effectiveness of Symptoms Monitoring via Computer-based Health Evaluation System (CHES) in Patients with Metastatic solid cancers during chemotherapy
Scientific Title:Acronym
PROMISE-KOBE Study
Region
| Japan |
Condition
Condition
Patients with metastatic solid cancer (gastric cancer, colorectal cancer and breast cancer) scheduled for first line chemotherapy (including molecular targeted drug and immune checkpoint inhibitor)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1)To clarify factors that decrease health related quality of life (HRQOL) of metastatic solid cancer patients undergoing chemotherapy at Kobe City Medical Center General Hospital.
2)To evaluate the effectiveness of patient's symptom monitoring via Computer-based Health Evaluation System
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EQ-5D-5L
Key secondary outcomes
Global Health Status scale in EORTC QLQ-C30
EORTC QLQ-C30(five functional scales and three multi-item symptom scales)
EORTC QLQ-CIPN20
Overall survival from the registration date
Association between clinicopatholigical factors and HRQOL
Association between sociodemographic factors and HRQOL
Association between visiting emergency room and HRQOL
Association between visiting palliative care unit and HRQOL
Association between symptom monitoring via Patient Portal Site and HRQOL
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with metastatic solid cancer (gastric cancer, colorectal cancer, breast cancer)
2) Patients who are scheduled for first-line chemotherapy (including molecular targeted drug and immune checkpoint inhibitor)
3) Patients who are going to do chemotherapy at the outpatient chemotherapy unit
4) Patient with ECOG Performance Status of 0 to 2.
5) Patients who are expected to have a prognosis of six months or more
6) Written informed consent, with the understanding that the patient may withdraw consent at any time without prejudice
Key exclusion criteria
1) Patients with serious complications
2) Patients who have clinically problematic mental illness
3) Patients judged inappropriate for enrolment by physician
Target sample size
115
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Kikawa |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Breast Surgery
Zip code
Address
2-2-1, Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan
TEL
+81-78-302-4321
u-1ro@kcho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichiro Kikawa |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Breast Surgery
Zip code
Address
2-2-1, Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan
TEL
+81-78-302-4321
Homepage URL
u-1ro@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe City Medical Center General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 01 | 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 | 10 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
The baseline HRQOL survey will be conducted during the period of registration and first chemotherapy. Two more evaluations will be performed after 12 weeks and 24 weeks from the treatment start date.
Furthermore, the following items will be evaluated;
sex, highest level of education, employment status, martial status, living situation, caner site, performance status, comorbidity, visiting history of emergency room and consultation history of palliative care unit
Management information
Registered date
| 2017 | Year | 10 | Month | 22 | Day |
Last modified on
| 2021 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033854
