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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025805
Receipt No. R000029674
Scientific Title An intervention study to the physical activity program for improving the sleep quality of cancer Survivor's
Date of disclosure of the study information 2017/02/10
Last modified on 2019/01/30

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Basic information
Public title An intervention study to the physical activity program for improving the sleep quality of cancer Survivor's
Acronym An intervention study for improving the sleep quality of cancer Survivor's
Scientific Title An intervention study to the physical activity program for improving the sleep quality of cancer Survivor's
Scientific Title:Acronym An intervention study for improving the sleep quality of cancer Survivor's
Region
Japan

Condition
Condition cancer
Classification by specialty
Hematology and clinical oncology Gastrointestinal surgery Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study were; 1) to clarify the changes of sleep quality undergoing chemotherapy by the physical activities, 2) to investigate effectiveness of the physical activity program to improves sleep quality; for cancer survivors.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the subjective sleep by PSQI-J
the objective sleep by Acitygraph
First: before intervention
Second: 2 week after intervention
Third: 4 week after intervention
Fourth: 8 week after intervention

Key secondary outcomes the amount of body activities
the fatigue by CFS
HRQOL by sf-36
a subjective symptom
a hematometry datum

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
Other
Interventions/Control_1 Implementation Activity Program
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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patient of hematopoietic neoplasms and gastrointestinal cancer
2)Patient have received the chemotherapy and the supportive treatment. (those who have carried out the symptom control by medication of a hypertension, a DM, etc. are involves to a subject).
3) Patient has poor sleep quality of PSQI-J scores greater than 6
4) Patient who can communicate others and consciousness
5) Performance Status 0-2
6) 20 -65 years old
7) Patient who can detach and attach a actigraph and an accelerometer by myself
Key exclusion criteria 1) Patient by whom a psychological burden is judged to be a gain by attend of a survey
2)Patient of a cutaneous sensitization
3)Patient by whom an everyday physical activity is restricted
(arrhythmia, ischemic heart disease, and heart failure are exist patients etc)
4)Patient has bone metastasis and motor disturbance
5)Patient who not desirable by researcher's judged
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayako Ura
Organization Fukuoka University
Division name Faculty of Medicine, School of Nursing
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL 092-801-1011
Email ayako@adm.fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayako Ura
Organization Fukuoka University
Division name Faculty of Medicine, School of Nursing
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL 092-801-1011
Homepage URL
Email ayako@adm.fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Faculty of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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
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
2017 Year 02 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
2017 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 10 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
2017 Year 01 Month 23 Day
Last modified on
2019 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029674

Research Plan
Registered date File name
2018/01/26 ②がん化学療法 睡眠 ≪研究計画≫IRB 12月16日修正 黒字 平成28 (修復済み).docx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/01/30 睡眠介入 解析 身体機能 対象の概要.xlsx


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