UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055154 |
|---|---|
| Receipt number | R000062986 |
| Scientific Title | Quality of life and self-care needs of older adults with cancer and cardiovascular disease: an observational study |
| Date of disclosure of the study information | 2024/08/05 |
| Last modified on | 2024/10/04 09:20:33 |
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Basic information
Public title
Quality of life and self-care needs of older adults with cancer and cardiovascular disease: an observational study
Acronym
Quality of life and self-care needs of older adults with cancer and cardiovascular disease: an observational study
Scientific Title
Quality of life and self-care needs of older adults with cancer and cardiovascular disease: an observational study
Scientific Title:Acronym
Quality of life and self-care of older adults with cancer and cardiovascular diseasey
Region
| Japan |
Condition
Condition
cancer, cardiovascular disease
Classification by specialty
| Cardiology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to identify the relationship between self-care needs, quality of life, and mental status in the daily lives of older adults with both cancer and cardiovascular disease.
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-care needs
Key secondary outcomes
QOL
The degree of mental status (anxiety, depression)
Idea and feelings about having both cancer and cardiovascular disease
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with both cancer and cardiovascular disease.
Patients under 65 years of age must meet all of the following inclusion criteria 1)-3) and 5),6).
If the patient is over 65 years old, the patient must satisfy all of the following criteria 1)-6).
1) Patients who have undergone/are undergoing cancer treatment (surgical therapy, chemotherapy, radiation therapy, etc.) after the diagnosis of cancer.
2) Patients diagnosed with cardiovascular disease before or after cancer onset or cancer treatment.
3) I. Questionnaire survey (quantitative research) has no age limit
4) II. Interview surveys (qualitative studies) are for persons 65 years of age or older
5) Persons who can give written consent to participate in this study
Key exclusion criteria
(1) Persons whose physician ( medical doctor in charge of treatment) determines that participation in the research will cause physical or mental burden.
(2) Patients who are unable to speak voluntarily in response to questions asked orally or in writing.
(3) Patients who are unable to speak Japanese.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Yagasaki |
Organization
Keio University
Division name
Faculty of Nurisng and Medhical Care
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
0353632157
yagasaki@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Yagasaki |
Organization
Keio University
Division name
Faculty of Nurisng and Medhical Care
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
0353632157
Homepage URL
yagasaki@sfc.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Kaori Yagasaki
Funding Source
Organization
Japan society for the promotion of 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
Keio University School of Medicine, Internal Ethics Committee
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
慶應義塾大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 05 | 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
| 2024 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observations: quality of life, mental status(depression and anxiety), needs related to having both cancer and cardiovascular disease
Management information
Registered date
| 2024 | Year | 08 | Month | 04 | Day |
Last modified on
| 2024 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062986
