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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043579
Receipt No. R000049766
Scientific Title The development and the effect of a self-help program focusing on activation and contingency perception for Cancer Survivors
Date of disclosure of the study information 2021/03/10
Last modified on 2021/03/10

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Basic information
Public title Live Value Commitment Self-help program for Cancer Survivors
Acronym LiVaC-C
Scientific Title The development and the effect of a self-help program focusing on activation and contingency perception for Cancer Survivors
Scientific Title:Acronym The development and the effect of a self-help program for Cancer Survivors
Region
Japan

Condition
Condition Cancer
Classification by specialty
Medicine in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To conduct a study to examine the effect of a self-help program booklet, which aimed to promote activation and contingency perception, on psychological adjustment in cancer survivors.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Psychological adjustment: Hospital Anxiety and Depression Scale (HADS),Benefit Finding Scale
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 YES
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Other
Interventions/Control_1 Self-help Treatment Group
Interventions/Control_2 Waiting 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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1.Diagnosed with cancer
2.Is told that they are diagnosed with cancer
3.Ages 20 to 89 years
Key exclusion criteria 1.Has difficulties in reading and writing Japanese
2.Is diagnosed with mental illness
3.Is receiving some kind of medication or counseling for mental health issues.
4.Has difficulties in carrying out the program due to mental condition
5. Has experienced a similar self-help program for psychosocial treatment
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Shinichi
Middle name
Last name Suzuki
Organization Waseda University, Faculty of Human Science
Division name Clinical Psychology Research
Zip code 3591192
Address 2-579-15 Mikajima,Tokorozawa, Saitama 359-1192, Japan
TEL 04-2949-8113
Email ssuzuki@waseda.jp

Public contact
Name of contact person
1st name Kotone
Middle name
Last name Hata
Organization Waseda University, Department of Human Science
Division name Clinical Psychology Research
Zip code 3591192
Address 2-579-15 Mikajima,Tokorozawa, Saitama
TEL 04-2949-8113
Homepage URL
Email koto.h711@akane.waseda.jp

Sponsor
Institute Waseda University, Department of Human Science
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science (JSPS)
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 Waseda University Ethics Review Procedures concerning Research with Human Subjects
Address 1-104 Totsukamachi, Shinjuku-ku, Tokyo, 169-8050
Tel 03-5272-1639
Email rinri@list.waseda.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
2021 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
2020 Year 12 Month 08 Day
Date of IRB
2021 Year 02 Month 02 Day
Anticipated trial start date
2021 Year 02 Month 05 Day
Last follow-up date
2021 Year 08 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
2021 Year 03 Month 10 Day
Last modified on
2021 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049766

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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