UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039749 |
|---|---|
| Receipt number | R000045299 |
| Scientific Title | Development of a Learning Program for Supporting Patients' Decision-Making in Cancer Clinical Trials |
| Date of disclosure of the study information | 2020/03/10 |
| Last modified on | 2023/09/15 19:41:08 |
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Basic information
Public title
Development of a Learning Program for Supporting Patients' Decision-Making in Cancer Clinical Trials
Acronym
Program SPDM
Scientific Title
Development of a Learning Program for Supporting Patients' Decision-Making in Cancer Clinical Trials
Scientific Title:Acronym
Program SPDM
Region
| Japan |
Condition
Condition
Healthy individuals (Nurses)
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the usefulness of a learning program for nurses who support patients' decision-making of whether to participate in cancer clinical trials
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of supporting patients' decision-making
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention group:
1-hour primary learning program for nurses including a lecture and dialogues among participants, and 1-hour follow up program for them about 3 months later
Interventions/Control_2
Control group:
Routine practice except for questionnaire surveys around the same time with intervention group
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.Nurses working at an outpatient division or an inpatient unit
2.Nurses obtained written informed consent
Key exclusion criteria
1.Nurses with nursing experience under one year
2.Certified nurses or Certified Nurse Specialists
3.Nurse managers
4.Nurses whom primary work are cross-sectoral practice
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Kohara, RN, DNSc, CCRP |
Organization
Jichi Medical University
Division name
School of Nursing
Zip code
329-0498
Address
3311-159 Yakushiji, Shimotsuke, Tochigi, 329-0498 Japan
TEL
0285-58-7425
ikohara@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Kohara, RN, DNSc, CCRP |
Organization
Jichi Medical University
Division name
School of Nursing
Zip code
329-0498
Address
3311-159 Yakushiji, Shimotsuke, Tochigi, 329-0498 Japan
TEL
0285-58-7425
Homepage URL
ikohara@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Bioethics Committee for Spidemiologic Research, Jichi Medical University
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, 329-0498 Japan
Tel
0285-44-2111
rinri@jichi.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 10 | 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
| 2019 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2024 | 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 | 03 | Month | 09 | Day |
Last modified on
| 2023 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045299
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
