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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023539
Receipt No. R000027110
Scientific Title The effect of web-based self-management intervention for quality of life and physical and psychological well-being in Cancer Patients
Date of disclosure of the study information 2016/09/01
Last modified on 2018/02/11

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Basic information
Public title The effect of web-based self-management intervention for quality of life and physical and psychological well-being in Cancer Patients
Acronym The effect of web-based self-management intervention for quality of life
Scientific Title The effect of web-based self-management intervention for quality of life and physical and psychological well-being in Cancer Patients
Scientific Title:Acronym The effect of web-based self-management intervention for quality of life
Region
Japan

Condition
Condition Cancer
Classification by specialty
Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effectiveness of web-based self-management interventions, which are based on empowering knowledge, the expressive writing, and writing a blog, for cancer patients/survivors in two-group, pretest-posttest quasi-experimental design.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes QOL
Key secondary outcomes Physical health (symptoms), Psychological adjustment (anxiety and depression), Characteristics and pattern of written essays, Usage of the website, and Satisfaction at the web-based intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 After the completion of baseline assessment, participants in the experimental group get an e-mail about the writing instructions, and start writing works. During writing works, participants make use of the contents of Empowering Knowledge. And after the completion of writing works, they get an ID number to use contents of Writing Blog and make use of it depending on each one's needs and ways. The expressive writing is carried out based on the procedure of a study of Lu et al. (2012). The experiment group is asked to write for 20 minutes about their deepest thoughts and feelings, their coping efforts, and positive thoughts and feelings regarding their experience with cancer each week for three weeks. Writing instructions differ for the corresponding week. Health outcomes are assessed at baseline (Time 1), and one month (Time 2) and two months (Time 3) after starting the intervention. Baseline questionnaire includes demographic and medical information data. They are mailed to participants each time.
Interventions/Control_2 Health outcomes are assessed at baseline (Time 1), and one month (Time 2) and two months (Time 3) after starting the study. Baseline questionnaire includes demographic and medical information data. They are mailed to participants each time.
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 The subjects of this study are cancer patients/survivors who are after the end of primary cancer treatment and are followed at outpatient units
Key exclusion criteria Patient age: less than 20 years, unawareness of cancer diagnosis, and having any psychiatric disorders
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name MIZUNO, Michiyo
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code
Address 1-1-1 Tennoudai Tsukuba-city Ibaraki 305-8575, JAPAN
TEL 029-853-8247
Email michiyo0611@md.tsukuba.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name MIZUNO, Michiyo
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code
Address 1-1-1 Tennoudai Tsukuba-city Ibaraki 305-8575, JAPAN
TEL 029-853-8247
Homepage URL https://plaza.umin.ac.jp/link_support/
Email michiyo0611@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology;
Japan Society for the Promotion Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 筑波大学附属病院(茨城県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 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 No longer recruiting
Date of protocol fixation
2016 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 10 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 08 Day
Last modified on
2018 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027110

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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