UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044880 |
|---|---|
| Receipt number | R000051259 |
| Scientific Title | Efficacy of comedy on health-related quality of life (HRQOL) in cancer survivors. |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2023/07/18 09:35:59 |
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Basic information
Public title
Efficacy of comedy on health-related quality of life (HRQOL) in cancer survivors.
Acronym
Efficacy of comedy on health-related quality of life (HRQOL) in cancer survivors.
Scientific Title
Efficacy of comedy on health-related quality of life (HRQOL) in cancer survivors.
Scientific Title:Acronym
Efficacy of comedy on health-related quality of life (HRQOL) in cancer survivors.
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of a 28-day comedy viewing program on cancer survivors' effectiveness on HRQOL of cancer survivors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of HRQOL (FACT-G) at Day 1 and Day 28
Key secondary outcomes
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
Comedy
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Persons who have given written consent to participate in the research.
2) Males and females who are 20 years of age or older at the time of obtaining consent.
3) Those who have been diagnosed with cancer.
4) Those whose cancer has been cured or is stable.
Key exclusion criteria
1) Patients undergoing drug therapy for cancer (except for hormone therapy to prevent recurrence in breast cancer, prostate cancer, etc.)
2) Those who are undergoing treatment for cancer recurrence or metastasis and are not stable.
3) Those who are in the terminal stage of cancer.
4) Those whom the principal investigator judges inappropriate for inclusion in the study (e.g., those suffering from mental illness and unable to make sound judgments on their own).
5) Those who are taking the pill.
Translated with www.DeepL.com/Translator (free version)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Sakamoto |
Organization
Kindai University Hospital
Division name
Psychosomatic medicine
Zip code
589-0014
Address
377-2 Ohno higashi
TEL
0723660221
ryo-sakamoto@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Sakamoto |
Organization
Kindai University Hospital
Division name
Psychosomatic medicine
Zip code
589-0014
Address
377-2 Ohno higashi
TEL
0723660221
Homepage URL
ryo-sakamoto@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kindai University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University Hospital
Address
377-2 Ohno higashi
Tel
0723660221
ryo-sakamoto@med.kindai.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | 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
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 16 | Day |
Last modified on
| 2023 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051259
