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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012842
Receipt No. R000015002
Scientific Title Self-help workbook intervention for cancer patients undergoing chemotherapy on an outpatient basis
Date of disclosure of the study information 2014/03/01
Last modified on 2016/01/15

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Basic information
Public title Self-help workbook intervention for cancer patients undergoing chemotherapy on an outpatient basis
Acronym Self-help workbook intervention for cancer patients
Scientific Title Self-help workbook intervention for cancer patients undergoing chemotherapy on an outpatient basis
Scientific Title:Acronym Self-help workbook intervention for cancer patients
Region
Japan

Condition
Condition Malingant disease
Classification by specialty
Medicine in general Hematology and clinical oncology Psychosomatic Internal Medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of self-help workbook intervention on quality of life in cancer patients undergoing chemotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Quality of Life (EORTC-QLQ C30, BR23)
Key secondary outcomes Care Note, Euro Qol (EQ-5D), Global Rating of Change Questionnaires, Hospital Anxiety and Depression Scale (HADS), Brief Coping Orientation to Problems Experienced (COPE)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 No intervention (standard chemotherapy only)
Interventions/Control_2 Self-help workbook intervention
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Cancer patients
2) Undergoing chemotherapy on an outpatient basis
3) General condition is good enough to participate in this study.
4) Subjects who can read Japanese and complete self-report questionnaires
Key exclusion criteria 1) Severe cognitive dysfunction
2) Severe psychiatric disorder
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshimi Takano
Organization Toranomon Hospital
Division name Department of Medical Oncology
Zip code
Address 2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan
TEL 03-3588-1111
Email takano@toranomon.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshimi Takano
Organization Toranomon Hospital
Division name Department of Medical Oncology
Zip code
Address 2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan
TEL 03-3588-1111
Homepage URL
Email takano@toranomon.gr.jp

Sponsor
Institute Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization None
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 虎の門病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 03 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
2014 Year 01 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 01 Month 14 Day
Last modified on
2016 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015002

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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