UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043579
Receipt number 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 15:38:55

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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 or person

Institute

Waseda University, Department of Human Science

Institute

Department

Personal name



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

Value
https://center6.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