{
"info": {
"nct_id": "NCT04735991",
"official_title": "A Real-world Clinical Study Evaluating the Quality of Life in Family Members of Colorectal Cancer Patients Based on a Whole Course Chronic Disease Management System for Cancer Patients' Family",
"inclusion_criteria": "* (1) Subject: The main family members caring for patients are ≥18 and ≤65 years old;\n* (2) Family members of patients who can understand the purpose of the study, voluntarily participate and sign an informed consent form, and are willing to complete follow-up as required by the protocol;\n* (3) Family members of colorectal cancer patients who need to receive adjuvant chemotherapy XELOX regimen within 6 months after initial diagnosis of high-risk stage II or stage III\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 65 Years",
"exclusion_criteria": "* (1) Patient life expectancy is less than 3 months\n* (2) Family members of patients cannot use electronic mobile products\n* (3) The family of the patient has a history of malignant tumors or other serious diseases\n* (4) Family members of patients are considered unsuitable by the researcher",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* (1) Subject: The main family members caring for patients are ≥18 and ≤65 years old;",
"criterions": [
{
"exact_snippets": "main family members caring for patients are ≥18 and ≤65 years old",
"criterion": "age of main family members",
"requirements": [
{
"requirement_type": "age range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 65,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* (2) Family members of patients who can understand the purpose of the study, voluntarily participate and sign an informed consent form, and are willing to complete follow-up as required by the protocol;",
"criterions": [
{
"exact_snippets": "Family members of patients",
"criterion": "relationship to patient",
"requirements": [
{
"requirement_type": "relationship",
"expected_value": "family member"
}
]
},
{
"exact_snippets": "can understand the purpose of the study",
"criterion": "understanding of study purpose",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "voluntarily participate",
"criterion": "voluntary participation",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
},
{
"exact_snippets": "sign an informed consent form",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signed",
"expected_value": true
}
]
},
{
"exact_snippets": "willing to complete follow-up as required by the protocol",
"criterion": "follow-up completion",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
}
]
},
{
"line": "* (3) Family members of colorectal cancer patients who need to receive adjuvant chemotherapy XELOX regimen within 6 months after initial diagnosis of high-risk stage II or stage III",
"criterions": [
{
"exact_snippets": "Family members of colorectal cancer patients",
"criterion": "family member of colorectal cancer patient",
"requirements": [
{
"requirement_type": "relationship",
"expected_value": "family member"
}
]
},
{
"exact_snippets": "need to receive adjuvant chemotherapy XELOX regimen",
"criterion": "adjuvant chemotherapy XELOX regimen",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": true
}
]
},
{
"exact_snippets": "within 6 months after initial diagnosis",
"criterion": "time since initial diagnosis",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
]
},
{
"exact_snippets": "high-risk stage II or stage III",
"criterion": "cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"high-risk stage II",
"stage III"
]
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 65 Years",
"criterions": [
{
"exact_snippets": "maximum age of 65 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 65,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* (1) Patient life expectancy is less than 3 months",
"criterions": [
{
"exact_snippets": "Patient life expectancy is less than 3 months",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 3,
"unit": "months"
}
}
]
}
]
},
{
"line": "* (2) Family members of patients cannot use electronic mobile products",
"criterions": [
{
"exact_snippets": "Family members of patients cannot use electronic mobile products",
"criterion": "family members' use of electronic mobile products",
"requirements": [
{
"requirement_type": "usage",
"expected_value": false
}
]
}
]
},
{
"line": "* (3) The family of the patient has a history of malignant tumors or other serious diseases",
"criterions": [
{
"exact_snippets": "The family of the patient has a history of malignant tumors",
"criterion": "family history of malignant tumors",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "The family of the patient has a history of ... other serious diseases",
"criterion": "family history of other serious diseases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* (4) Family members of patients are considered unsuitable by the researcher",
"criterions": [
{
"exact_snippets": "Family members of patients",
"criterion": "family member status",
"requirements": [
{
"requirement_type": "suitability",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}