UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005004
Receipt number 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 14:44:04

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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 or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



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

Value
https://center6.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