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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039749
Receipt No. 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 2020/09/28

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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
Email 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
Email ikohara@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

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
Email 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 Enrolling by invitation
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
2022 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
2020 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.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


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