UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001140
Receipt number R000000985
Scientific Title Multicenter Before-After Study of Dignity Therapy for Japanese Cancer Patients
Date of disclosure of the study information 2008/04/30
Last modified on 2009/01/04 16:02:53

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Basic information

Public title

Multicenter Before-After Study of Dignity Therapy for Japanese Cancer Patients

Acronym

Dignity Therapy in Japan

Scientific Title

Multicenter Before-After Study of Dignity Therapy for Japanese Cancer Patients

Scientific Title:Acronym

Dignity Therapy in Japan

Region

Japan


Condition

Condition

Advanced and/or terminally ill cancer

Classification by specialty

Psychiatry

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to examine the feasibility and usability of dignity therapy for alleviation of existential sufferings of advanced and/or terminally ill cancer patients in Japan with multicenter before-after study.

Basic objectives2

Others

Basic objectives -Others

Feasibility/ Usability

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being; The 12-item Spiritual Well-Being Scale(FACIT-Sp-12); meaning/peace

Key secondary outcomes

1. Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being; The 12-item Spiritual Well-Being Scale(FACIT-Sp-12); faith
2. Structured Interview Assessment of Symptom and Concerns(SISC)
3. Revised M.D. Anderson Symptom Inventory (Revised MDASI)
4. Quality of Dying Inventory (QDI)
5. Dignity Therapy Feedback Questionnaire(DTFQ)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Dignity therapy

Interventions/Control_2


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. The patient was diagnosed with cancer and explained about his diagonosis
2. Diagnosis of incurable cancer with a life expectancy of less than 6 months
3. Age older than 20 years
4. Japanese speaking
5. Ability to participate in 30-60 minutes-interviews for several times during seven to ten days
6. No evidence of severe cognitive impairment such as dementia and delirium
7. Ability to provide oral and written informed consent

Key exclusion criteria

1. The patients whose primary physician assessed that he /she is unable to complete the study due to the severity of physical and mental condition
2. Impossible to make linguistic communication
3. Metastases to brain with the symptoms
4. A case in which a primary physician assessed that the patient is not appropriate for the participant of the study

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tatsuo Akechi

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Psychiatry and Cognitive-Behavioral Medicine

Zip code


Address

Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya 467-8601 JAPAN

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Terukazu Akazawa

Organization

Seirei Mikatahara General Hospital

Division name

Hamamatsu Cancer Support Center

Zip code


Address

3453 Mikatahara-cho, Kita-Ku, Hamamatsu, Shizuoka 433-8558 JAPAN

TEL


Homepage URL


Email



Sponsor or person

Institute

Nagoya City University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


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



Other administrative information

Date of disclosure of the study information

2008 Year 04 Month 30 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

2007 Year 08 Month 23 Day

Date of IRB


Anticipated trial start date

2007 Year 09 Month 01 Day

Last follow-up date

2008 Year 10 Month 01 Day

Date of closure to data entry

2008 Year 10 Month 01 Day

Date trial data considered complete

2008 Year 10 Month 01 Day

Date analysis concluded

2009 Year 08 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 04 Month 30 Day

Last modified on

2009 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000985


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name