UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023539 |
|---|---|
| Receipt number | 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 | 2023/08/14 12:00:41 |
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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
Name of lead principal investigator
| 1st name | Michiyo |
| Middle name | |
| Last name | MIZUNO, Michiyo |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennoudai Tsukuba-city Ibaraki 305-8575, JAPAN
TEL
0298538247
michiyo0611@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Michiyo |
| Middle name | |
| Last name | MIZUNO |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennoudai Tsukuba-city Ibaraki 305-8575, JAPAN
TEL
0298538247
Homepage URL
https://plaza.umin.ac.jp/link_support/
michiyo0611@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
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
University of Tsukuba
Address
1-1-1 Tennoudai Tsukuba-city Ibaraki 305-8575, JAPAN
Tel
029-853-3914
t-credo.adm@un.tsukuba.ac.jp
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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 30 | Day |
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
| 2023 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027110
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| Registered date | File name |
| Research case data | |
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