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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005004
Receipt No. R000005942
Scientific Title Spiritual care of cancer patients by integrated medicine in a forest park
Date of disclosure of the study information 2011/02/02
Last modified on 2011/02/02

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Basic information
Public title Spiritual care of cancer patients by integrated medicine in a forest park
Acronym Spiritual care of cancer patients in a forest park
Scientific Title Spiritual care of cancer patients by integrated medicine in a forest park
Scientific Title:Acronym Spiritual care of cancer patients in a forest park
Region
Japan

Condition
Condition breast cancer, lung cancer
Classification by specialty
Chest surgery Breast surgery Psychiatry
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Psycho-oncological care including spiritual care is essential for cancer patients. Integrated medicine, a therapy combining modern western medicine with various kinds of complementary and alternative medicine (CAM), can be appropriate for the spiritual care of cancer because of the multidimensional characteristics of the spirituality. In particular, therapies that enable patients to establish a deeper contact with nature, inspire feelings of life and growth of plants, and involve meditation may be useful for spiritual care. The purpose of our study was to examine the effect of spiritual care of cancer patients by integrated medicine in a green environment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Spirituality (the Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing; FACIT-Sp) before and after intervention
Key secondary outcomes Quality of life (QOL; SF-36), fatigue (cancer fatigue scale; CFS), psychological state (POMS and STAI), circadian rhythm and NK cell activity before and after intervention

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 Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 A program consisted of forest therapy, horticultural therapy, yoga meditation and support group therapy once a week for 12 weeks
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
70 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients who had been diagnosed with cancer.
2. Patients aged between 20 and 70 years.
3. More than 1 month had passed after the patient had undergone surgery, chemotherapy or irradiation.
4. Patients judged by a physician to be able to participate in the study.
5. Selection was made irrespective of type and progression of cancer.
Key exclusion criteria Patients who do not meet inclusion criteria
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jiro Imanishi
Organization Kyoto Prefectural University of Meidicine Graduate School of Medical Science
Division name Department of Microbiology
Zip code
Address 465, Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5330
Email

Public contact
Name of contact person
1st name
Middle name
Last name Jiro Imanishi
Organization Meiji University of Integrative Medicine
Division name Center for Integrative Meidicine
Zip code
Address 2-4, Higashisakaidani-cho, Ooharano, Nishikyo-ku, Kyoto, Japan
TEL 075-333-1386
Homepage URL
Email imanishi-micro@nifty.com

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization The Commemorative Organization for the Japan World Exposition' 70
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kyoto University, Osaka University, and Takatsuki Red Cross Hospital
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 万博公園(大阪府)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 02 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 10 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 02 Month 02 Day
Last modified on
2011 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005942

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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