Status Approved
First Submitted Date
2017/03/06
Registered Date
2019/04/25
Last Updated Date
2019/04/24
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0003846 |
|---|---|
| Unique Protocol ID | 4-2016-0522 |
| Public/Brief Title | Assessment of Quality of Life and Building Cohort for management of Colorectal Cancer Survivors |
| Scientific Title | Assessment of Quality of Life and Building Cohort for management of Colorectal Cancer Survivors Development of Comprehensive Manual for Korean Colorectal Cancer Survivors |
| Acronym | MKCCS – I |
| MFDS Regulated Study | No |
| IND/IDE Protocol | No |
| Registered at Other Registry | No |
| Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
| Board Approval Status | Submitted approval |
|---|---|
| Board Approval Number | 4-2016-0522 |
| Approval Date | 2016-08-08 |
| Institutional Review Board Name | Yonsei University Health System, Severance Hospital, Institutional Review Board |
| Institutional Review Board Address | (03722) 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea |
| Institutional Review Board Telephone | 02-2228-0500 |
| Data Monitoring Committee | No |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | Tae Il Kim |
| Title | Professor |
| Telephone | +82-2-2228-4940 |
| Affiliation | Yonsei University Health System, Severance Hospital |
| Address | 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Korea |
| Contact Person for Public Queries | |
| Name | Ji Soo Park |
| Title | ClinicalAssistantPro |
| Telephone | +82-2-2228-4940 |
| Affiliation | Yonsei University Health System, Severance Hospital |
| Address | Cancer Prevention Center, 5F Yonsei Cancer Center, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Korea |
| Contact Person for Updating Information | |
| Name | Ji Soo Park |
| Title | ClinicalAssistantPro |
| Telephone | +82-2-2228-4940 |
| Affiliation | Yonsei University Health System, Severance Hospital |
| Address | Cancer Prevention Center, 5F Yonsei Cancer Center, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Korea |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Recruiting | |
| Date of First Enrollment | 2016-10-06 Actual | |
| Target Number of Participant | 400 | |
| Primary Completion Date | 2021-04-30 , Anticipated | |
| Study Completion Date | 2021-04-30 , Anticipated | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Yonsei University Health System, Severance Hospital | |
| Recruitment Status | Recruiting | |
| Date of First Enrollment | 2016-10-06 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Ministry of Health & Welfare |
| Organization Type | Government |
| Project ID | 1631020 |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Yonsei University Health System, Severance Hospital |
| Organization Type | Medical Institute |
7. Study Summary
| Lay Summary | This study is the first step of "Assessment of Quality of Life and Building Cohort for management of Colorectal Cancer Survivors". This study aims to find the factors improving quality of life of colorectal cancer survivors, and the power of influence of the factors. In addition, we build the colorectal cancer cohort fo further study. With advance in diagnosis and treatment of cancer, the number of Korean cancer survivors were estimated as 1,370,000 in 2013. Long-term cancer survivors, who were diagnosed with cancer at least 5 years ago, are also increasing. Although these cancer survivors have many problems in bowel movement, defecation, sexual dysfunction, and peripheral neuropathy, the objective data and investigations regarding the relevant factors to the quality of life are not enough. In this study, we will find the factors significantly related to quality of life of cancer survivors, build intensive management cohort, and produce "screening tools for management of colorectal cancer survivors in clinical practice". |
|---|
8. Study Design
| Study Type | Observational Study |
|---|---|
| Observational Study Model | Cohort |
| Time Perspective | Prospective |
| Target Number of Participant | 400 |
| Cohort/Group Number | 1 |
|
Cohort/ Group 1 |
Cohort/Group Label Intensive management cohort for assessment of quality of life of colorectal cancer survivors |
|
Cohort/Group Description For two years, we will build an intensive management cohort for assessment of quality of life and the related factors of colorectal cancer survivors. In this cohort, we will investigate various questionnaires and assessment tools for quality of life of cancer survivors. |
|
| Biospecimen Collection & Archiving |
Not collect nor Archive |
| Biospecimen Description |
9. Subject Eligibility
| Study Population Description | Men and women aged 19 years or older, who were diagnosed with colorectal cancer and completed cancer treatment at least 4 weeks prior to enrollment |
|---|---|
| Sampling Method | Non-probablity sampling, quota sampling |
| Condition(s)/Problem(s) |
* (C00-D48)Neoplasms (C18.9)Malignant neoplasm of colon, unspecified Colonic Neoplasms; Survivors; Quality of Life |
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 19Year~No Limit |
|
|
Description (1) Men and women aged 19 years or older (2) Histologically or cytologically diagnosed with colorectal cancer (3) As per AJCC cancer staging 7th edeition, stage I, II, or III disease; or if the patients had stage IV disease, the metastatic lesions were limited to liver or lung, and the patients underwent curative resection for metastatic lesions; All cancer treatment (including chemotherapy, radiotherapy, and operation) were completed at least 4 weeks prior to enrollment of study; no residual cancer (4) 0, 1, or 2 of performance status score as per Eastern Cooperative Oncology Group (ECOG) Scale (5) Those who are able to read and understand the informed consent form |
|
| Exclusion Criteria |
(1) If the patients were diagnosed with cancers other than colorecal cancers, less than 5 years since the patients were diagnosed with the other malignancy (2) Unable to read and understand the informed consent form. |
| Healthy Volunteers | No |
10. Outcome Measure(s)
| Type of Primary Outcome | Not applicable | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | Quality of life of colorectal cancer survivors |
|
| Timepoint | At the time of enrollment, and every year |
|
| Secondary Outcome(s) 1 | ||
| Outcome | cancer recurrence |
|
| Timepoint | At the time of enrollment, and every year |
|
| Secondary Outcome(s) 2 | ||
| Outcome | ocurrence of second malignant neoplasm |
|
| Timepoint | At the time of enrollment, and every year |
|
| Secondary Outcome(s) 3 | ||
| Outcome | cancer-specific survival |
|
| Timepoint | At the time of enrollment, and every year |
|
11. Study Results and Publication
| Result Registered | No |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | Not provided at time of Registration |
|---|
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