UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000025805
Receipt number	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 18:03:01

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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

cancer

Classification by specialty

Hematology and clinical oncology Gastrointestinal surgery Nursing

Classification by malignancy

Malignancy

Genomic information

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

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

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 or person

Institute

Fukuoka University Faculty of Medicine

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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