{
"info": {
"nct_id": "NCT06415266",
"official_title": "Multicentric Randomized Study eValuating the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request",
"inclusion_criteria": "* Woman or man at least 18 years old\n* Diagnosis of infiltrating breast cancer regardless of the biological characteristics of the tumor\n* Standard treatment by surgery, radiotherapy and/or chemotherapy, completed a maximum of 3 months ago with the exception of post-neoadjuvant treatments (chemotherapy, poly(ADP-ribose) polymerase (PARP) inhibitor, immunotherapy, targeted treatment, ...) which must have been started less than 3 months previously\n* Patient with sufficient command of the French language to be able to answer the questionnaires\n* Patient having given informed, written and express consent.\n* Affiliation to the French Social Security System\n* Willingness and ability to comply with scheduled visits, treatment plan and other study procedures\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patient already taken cared of in oncosexology. The following are not criteria for non-inclusion (a previous single consultation without treatment, use of local vaginal treatments)\n* Metastatic disease\n* Patient under guardianship, curatorship or safeguard of justice",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Woman or man at least 18 years old",
"criterions": [
{
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"criterion": "gender",
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}
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{
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"value": 18,
"unit": "years"
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}
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},
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},
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{
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"criterion": "infiltrating breast cancer",
"requirement": {
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"expected_value": true
}
}
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},
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"exact_snippets": "Diagnosis of infiltrating breast cancer",
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"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Standard treatment by surgery, radiotherapy and/or chemotherapy, completed a maximum of 3 months ago with the exception of post-neoadjuvant treatments (chemotherapy, poly(ADP-ribose) polymerase (PARP) inhibitor, immunotherapy, targeted treatment, ...) which must have been started less than 3 months previously",
"criterions": [
{
"exact_snippets": "Standard treatment by surgery, radiotherapy and/or chemotherapy, completed a maximum of 3 months ago",
"criterion": "standard treatment completion",
"requirement": {
"requirement_type": "time since completion",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
},
{
"exact_snippets": "post-neoadjuvant treatments (chemotherapy, poly(ADP-ribose) polymerase (PARP) inhibitor, immunotherapy, targeted treatment, ...) which must have been started less than 3 months previously",
"criterion": "post-neoadjuvant treatment initiation",
"requirement": {
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"expected_value": {
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"value": 3,
"unit": "months"
}
}
}
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"and_criteria": [
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"exact_snippets": "Standard treatment by surgery, radiotherapy and/or chemotherapy, completed a maximum of 3 months ago",
"criterion": "standard treatment completion",
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"value": 3,
"unit": "months"
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{
"and_criteria": [
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"exact_snippets": "post-neoadjuvant treatments (chemotherapy, poly(ADP-ribose) polymerase (PARP) inhibitor, immunotherapy, targeted treatment, ...) which must have been started less than 3 months previously",
"criterion": "post-neoadjuvant treatment initiation",
"requirement": {
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"unit": "months"
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{
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"line": "* Patient with sufficient command of the French language to be able to answer the questionnaires",
"criterions": [
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"requirement": {
"requirement_type": "proficiency",
"expected_value": "sufficient"
}
}
]
},
"logical_structure": {
"and_criteria": [
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{
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},
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"exact_snippets": "Patient having given informed, written and express consent.",
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},
{
"identified_line": {
"line": "* Affiliation to the French Social Security System",
"criterions": [
{
"exact_snippets": "Affiliation to the French Social Security System",
"criterion": "affiliation to the French Social Security System",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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"exact_snippets": "Affiliation to the French Social Security System",
"criterion": "affiliation to the French Social Security System",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Willingness and ability to comply with scheduled visits, treatment plan and other study procedures",
"criterions": [
{
"exact_snippets": "Willingness and ability to comply with scheduled visits",
"criterion": "compliance with scheduled visits",
"requirement": {
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"expected_value": true
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},
{
"exact_snippets": "Willingness and ability to comply with scheduled visits",
"criterion": "compliance with scheduled visits",
"requirement": {
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"expected_value": true
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},
{
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"criterion": "compliance with treatment plan",
"requirement": {
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"expected_value": true
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},
{
"exact_snippets": "Willingness and ability to comply with ... treatment plan",
"criterion": "compliance with treatment plan",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with ... other study procedures",
"criterion": "compliance with other study procedures",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with ... other study procedures",
"criterion": "compliance with other study procedures",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Willingness and ability to comply with scheduled visits",
"criterion": "compliance with scheduled visits",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with scheduled visits",
"criterion": "compliance with scheduled visits",
"requirement": {
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"expected_value": true
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}
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},
{
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"criterion": "compliance with treatment plan",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with ... treatment plan",
"criterion": "compliance with treatment plan",
"requirement": {
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"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Willingness and ability to comply with ... other study procedures",
"criterion": "compliance with other study procedures",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with ... other study procedures",
"criterion": "compliance with other study procedures",
"requirement": {
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"expected_value": true
}
}
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}
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{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"expected_value": "healthy"
}
}
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"exact_snippets": "Healthy volunteers allowed",
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}
},
{
"identified_line": {
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{
"exact_snippets": "minimum age of 18 Years",
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"unit": "Years"
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"line": "* Patient already taken cared of in oncosexology. The following are not criteria for non-inclusion (a previous single consultation without treatment, use of local vaginal treatments)",
"criterions": [
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"criterion": "oncosexology care",
"requirement": {
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{
"exact_snippets": "a previous single consultation without treatment",
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"expected_value": true
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{
"exact_snippets": "use of local vaginal treatments",
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}
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}
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"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}