{
"info": {
"nct_id": "NCT05035173",
"official_title": "Women's Cancer Survivorship: The LYSA (Linking You to Support and Advice) Trial",
"inclusion_criteria": "1. Women aged > or = 18 years.\n2. Ability to read and understand English.\n3. Access to internet.\n4. Early-stage breast/gynaecologic cancer within 12 months of completion of primary curative therapy:\n\n * Breast cancer: Stage I-III hormone receptor-positive (defined as estrogen receptor and/or progesterone receptor ≥ 1%) and HER2-negative per ASCO-CAP guidelines on or recommended to commence adjuvant endocrine therapy during the study period.\n * Cervical cancer: Stage I to III treated with curative intent.\n * Endometrial cancer: treated with curative intent adjuvant radiotherapy +/- chemotherapy\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Patients who are not treated with curative intent as above.\n2. Patients with premalignant disease.\n3. Persons who, in the opinion of the researcher or supervising clinician, are unable to cooperate adequately with the study protocol.\n4. Recent (within 12 months) participation in a study/programme involving a lifestyle intervention (e.g diet, exercise, survivorship). Note: Per discretion of PI as to whether may impact the outcome of this study intervention.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Women aged > or = 18 years.",
"criterions": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirement": {
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"expected_value": "female"
}
},
{
"exact_snippets": "aged > or = 18 years",
"criterion": "age",
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
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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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"expected_value": true
}
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},
"logical_structure": {
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{
"exact_snippets": "Ability to read and understand English.",
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}
}
]
}
},
{
"identified_line": {
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"expected_value": true
}
}
]
},
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"exact_snippets": "Access to internet",
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}
}
]
}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Early-stage breast/gynaecologic cancer",
"criterion": "cancer type and stage",
"requirement": {
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]
}
},
{
"exact_snippets": "Early-stage breast/gynaecologic cancer",
"criterion": "cancer type and stage",
"requirement": {
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"expected_value": "early-stage"
}
},
{
"exact_snippets": "within 12 months of completion of primary curative therapy",
"criterion": "time since completion of primary curative therapy",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 12,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Early-stage breast/gynaecologic cancer",
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"requirement": {
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]
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}
}
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},
{
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"unit": "months"
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},
{
"identified_line": {
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"criterions": [
{
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"criterion": "breast cancer stage",
"requirement": {
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"expected_value": {
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{
"operator": ">=",
"value": 1,
"unit": "Stage"
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{
"operator": "<=",
"value": 3,
"unit": "Stage"
}
]
}
}
},
{
"exact_snippets": "hormone receptor-positive (defined as estrogen receptor and/or progesterone receptor ≥ 1%)",
"criterion": "hormone receptor status",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
},
{
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"criterion": "hormone receptor status",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 1,
"unit": "%"
}
}
},
{
"exact_snippets": "HER2-negative per ASCO-CAP guidelines",
"criterion": "HER2 status",
"requirement": {
"requirement_type": "status",
"expected_value": "negative"
}
},
{
"exact_snippets": "recommended to commence adjuvant endocrine therapy during the study period",
"criterion": "adjuvant endocrine therapy",
"requirement": {
"requirement_type": "recommendation",
"expected_value": "commence during the study period"
}
}
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},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
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"unit": "Stage"
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{
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}
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{
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"expected_value": {
"operator": ">=",
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"unit": "%"
}
}
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{
"exact_snippets": "HER2-negative per ASCO-CAP guidelines",
"criterion": "HER2 status",
"requirement": {
"requirement_type": "status",
"expected_value": "negative"
}
}
]
},
{
"exact_snippets": "recommended to commence adjuvant endocrine therapy during the study period",
"criterion": "adjuvant endocrine therapy",
"requirement": {
"requirement_type": "recommendation",
"expected_value": "commence during the study period"
}
}
]
}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Cervical cancer",
"criterion": "cervical cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Stage I to III",
"criterion": "cervical cancer stage",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "Stage"
},
{
"operator": "<=",
"value": 3,
"unit": "Stage"
}
]
}
}
},
{
"exact_snippets": "treated with curative intent",
"criterion": "treatment intent",
"requirement": {
"requirement_type": "intent",
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}
}
]
},
"logical_structure": {
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"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Stage I to III",
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"requirement": {
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"operator": ">=",
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"unit": "Stage"
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"unit": "Stage"
}
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{
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}
}
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}
},
{
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{
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"criterion": "gender",
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}
}
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}
},
{
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"unit": "Years"
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"unit": "Years"
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],
"exclusion_lines": [],
"miscellaneous_lines": [],
"failed_inclusion": [
{
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"line": "* Endometrial cancer: treated with curative intent adjuvant radiotherapy +/- chemotherapy",
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}
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{
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{
"exact_snippets": "Recent (within 12 months) participation in a study/programme involving a lifestyle intervention",
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"requirement": {
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"value": 12,
"unit": "months"
}
}
}
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],
"failed_miscellaneous": []
}