UMIN-CTR Clinical Trial

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
Email	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
Email	u-1ro@kcho.jp

Sponsor
Institute	Kobe City Medical Center General Hospital
Institute
Department

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
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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033854