UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042447 |
|---|---|
| Receipt number | R000048457 |
| Scientific Title | Multicenter, Open-label, Randomized Comparative Study to Verify the Usefulness of Monitoring of Electronic Patient Reported Outcome (ePRO) in Patients with Unresectable Advanced Cancers and Metastasized or Relapsed Solid Tumors(PRO-MOTE) |
| Date of disclosure of the study information | 2020/11/13 |
| Last modified on | 2024/04/16 16:37:06 |
* 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
Multicenter, Open-label, Randomized Comparative Study to Verify the Usefulness of Monitoring of Electronic Patient Reported Outcome (ePRO) in Patients with Unresectable Advanced Cancers and Metastasized or Relapsed Solid Tumors (PRO-MOTE)
Acronym
PRO-MOTE
Scientific Title
Multicenter, Open-label, Randomized Comparative Study to Verify the Usefulness of Monitoring of Electronic Patient Reported Outcome (ePRO) in Patients with Unresectable Advanced Cancers and Metastasized or Relapsed Solid Tumors(PRO-MOTE)
Scientific Title:Acronym
PRO-MOTE
Region
| Japan |
Condition
Condition
Unresectable Advanced Cancers and Metastasized or Relapsed Solid Tumors(Breast cancer, lung cancer, stomach cancer, colon cancer, squamous cell carcinoma of the head and neck, liver cancer, endometrial cancer, ovarian cancer)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Breast surgery | Obstetrics and Gynecology |
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the hypothesis that adding ePRO monitoring to standard care is useful for prolonging OS or maintaining or improving HRQoL in patients with unresectable advanced cancers and metastasized or relapsed solid tumors who are receiving systemic pharmacotherapy.
Basic objectives2
Others
Basic objectives -Others
Verify
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) OS
(2) HRQoL
The global health status score on the The European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30) at all measurement time points to Week 24 after enrollment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
[Monitoring arm]
ePRO monitoring will be conducted once weekly after study enrollment. The monitoring will concern treatment of each predefined type of cancer or characteristic symptoms of the condition. PRO-CTCAE (Patient-Reported Outcome-Common Terminology Criteria for Adverse Events) will be used as the scale for monitoring symptoms. The patient and (sub)investigator will share the monitoring results during examinations and use them to determine treatment strategies, etc. Threshold values will be predefined for a diagnosis of "severe" for individual symptoms. When it is reported that a threshold value has been exceeded, an alert notification will be sent to the study staff member assigned to the patient. The (sub)investigator who receives the notification will assess the information in the notification and take the best course of action.
Interventions/Control_2
[Control arm]
Standard care will be given.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Unresectable, advanced, metastasized, or relapsed solid tumors
(2) Expected to be able to undergo treatment or observation for at least 6 months at the study site
(3) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
(4) Receiving systemic anticancer mono- or combination pharmacotherapy (e.g., cytotoxic anticancer agents, molecularly targeted drugs, and immune checkpoint inhibitors) at enrollment or scheduled to begin such therapy within 1 month from the date of enrollment
(In principle, patients should be receiving pharmacotherapy on an out-patient basis.)
(5) Capable of using electronic device (includes cases needing some assistance)
(6) Aged >=18 at informed consent
(7) Written consent for the study personally obtained from the subject
Key exclusion criteria
(1) Has undergone four or more regimens of pharmacotherapy for advanced, metastasized, or relapsed solid tumors*Notes 1, 2
(2) Currently participating in a study where PRO is tracked and the results are passed on to a physician
(3) The following are exclusion criteria for individual types of cancer
1) Breast cancer
- Scheduled to receive or currently receiving endocrine therapy (including endocrine therapy in combination with other agents) for hormone receptor-positive breast cancer
- Scheduled to receive or currently receiving first regimen of anti-HER2 therapy for HER2-positive disease
2) Liver cancer
- Hepatic function of Child-Pugh B/C
(4) Ongoing or planned radical radiotherapy
(5) Deemed otherwise unsuitable for the study by the investigator or sub-investigator
*Notes:
1. If the disease has relapsed during perioperative adjuvant chemotherapy or within 24 weeks after adjuvant chemotherapy, the adjuvant chemotherapy will be considered as the first regimen of adjuvant chemotherapy.
2. Does not include endocrine therapy for breast cancer.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Minami |
Organization
Kobe University Graduate School
Division name
Oncology and Hematology, Internal Medicine Program, Medical Research Division
Zip code
650-0017
Address
7-5-1, Kusunokicho, Chuo-ku, Kobe City, Hyogo Prefecture
TEL
078-382-5820
hminami@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Yamao |
Organization
Public Health Research Foundation
Division name
Office of Comprehensive Support Project for Oncology Research (CSPOR)
Zip code
169-0051
Address
1-1-7 Nishiwaseda, Shinjuku-ku, Tokyo
TEL
03-5287-2636
Homepage URL
csp-qol@csp.or.jp
Sponsor or person
Institute
Public Health Research Foundation
Institute
Department
Personal name
Funding Source
Organization
National Institute of Public Health
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe university hospital clinical and translational research center
Address
7-5-1, Kusunokicho, Chuo-ku, Kobe City, Hyogo Prefecture
Tel
078-382-6669
kainyu@med.kobe-u.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
手稲渓仁会病院 腫瘍内科 (北海道), 群馬県立がんセンター 呼吸器内科 (群馬県), 神戸大学 腫瘍・血液内科 (兵庫県), 川崎医科大学 臨床腫瘍科 (岡山県), 名古屋医療センター 腫瘍内科 (愛知県), 関西医科大学附属病院 乳腺外科 (大阪府), 関西労災病院 産婦人科 (兵庫県), 川崎医科大学附属病院 乳腺甲状腺外科 (岡山県), 市立札幌病院 消化器内科 (北海道), 東京大学医学部附属病院 消化器内科 (東京都), 千葉県がんセンター 消化器内科 (千葉県), 春日部市立医療センター 呼吸器内科 (埼玉県), 弘前大学大学院医学研究科 消化器血液内科学講座 (青森県), 沖縄病院 呼吸器内科 (沖縄県), 岡山大学病院 呼吸器・アレルギー内科 (岡山県), 東京女子医科大学病院 化学療法・緩和ケア科 (東京都), 神奈川県立がんセンター 消化器内科 消化管 (神奈川県), 岡山大学病院 乳腺・内分泌外科 (岡山県), 山形県立中央病院 呼吸器内科 (山形県), 大阪赤十字病院 腫瘍内科 (大阪府), NTT東日本関東病院 呼吸器内科 (東京都), 関西医科大学総合医療センター 消化器肝臓内科 (大阪府), 静岡がんセンター 消化器内科 (静岡県), 愛知県がんセンター 乳腺科部 (愛知県), 杏林大学医学部付属病院 呼吸器内科 (東京都), 兵庫県立尼崎総合医療センター 乳腺外科 (兵庫県), 順天堂大学医学部附属順天堂医院 産婦人科 (東京都), 愛知県がんセンター 薬物療法部 (愛知県), 栃木県立がんセンター 呼吸器内科 (栃木県), 八尾市立病院 乳腺外科 (大阪府), 埼玉県立がんセンター 消化器内科 (埼玉県), 日本医科大学付属病院 呼吸器内科 (東京都), 久留米総合病院 乳腺外科 (福岡県), 斗南病院 腫瘍内科 (北海道), 相澤病院 化学療法科 (長野県), 山口大学医学部附属病院 消化器・腫瘍外科 (山口県), 北海道大学病院 腫瘍内科 (北海道), 東北大学病院 腫瘍内科 (宮城県), 博愛会 相良病院 乳腺・甲状腺外科 (鹿児島県), 京都大学医学部附属病院 乳腺外科 (京都府), 兵庫医科大学 消化管内科 (兵庫県), 四国がんセンター 乳腺科 (愛媛県), 岡山大学病院 産科・婦人科学 (岡山県), 静岡県立総合病院 腫瘍内科 (静岡県), 秋田大学医学部附属病院 乳腺・内分泌外科 (秋田県), 東邦大学医療センター大森病院 消化器内科 (東京都), 神奈川県立がんセンター 消化器内科・肝胆膵 (神奈川県), 北里大学病院 乳腺甲状腺外科 (神奈川県), 大阪府済生会野江病院 乳腺外科 (大阪府)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2026 | 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
| 2020 | Year | 11 | Month | 13 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048457
