{
"info": {
"nct_id": "NCT03421782",
"official_title": "Nonpharmacologic Interventions for Fatigue in Patients With Cancer",
"inclusion_criteria": "* Diagnosed with advanced prostate cancer\n* Currently treated with hormone therapy-based regimen, including selective estrogen receptor modulators (SERMs), aromatase inhibitors, selective estrogen receptor down regulators (SERDs), CYP17A1 inhibitors, gonadotrophin releasing hormone (GnRH) agonists/antagonists, and antiandrogens; concurrent anti-HER2 therapy and other targeted therapy (e.g., CDK4/6 inhibitor, mTOR inhibitor) is permitted; must have started the current regimen at least 4 weeks prior to enrollment\n* A response of at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired) to the question ?how tired did you feel in the past week??\n* Sedentary activity pattern (Average < 90 minutes per week of moderate-to-vigorous intensity sports activity based on patient self-report) within the past year\n* Physically able to exercise and physician consent to start an exercise program\n* Regular access to a computer with internet service\n* Must be able to read and understand English\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines\nHealthy volunteers allowed",
"exclusion_criteria": "* Evidence of disease progression at the time of enrollment\n* Treatment with cytotoxic chemotherapy within 3 months prior to enrollment\n* Prior cognitive-behavioral therapy",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Diagnosed with advanced prostate cancer",
"criterions": [
{
"exact_snippets": "Diagnosed with advanced prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "advanced"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Diagnosed with advanced prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "advanced"
}
}
]
}
},
{
"identified_line": {
"line": "* Currently treated with hormone therapy-based regimen, including selective estrogen receptor modulators (SERMs), aromatase inhibitors, selective estrogen receptor down regulators (SERDs), CYP17A1 inhibitors, gonadotrophin releasing hormone (GnRH) agonists/antagonists, and antiandrogens; concurrent anti-HER2 therapy and other targeted therapy (e.g., CDK4/6 inhibitor, mTOR inhibitor) is permitted; must have started the current regimen at least 4 weeks prior to enrollment",
"criterions": [
{
"exact_snippets": "Currently treated with hormone therapy-based regimen, including selective estrogen receptor modulators (SERMs), aromatase inhibitors, selective estrogen receptor down regulators (SERDs), CYP17A1 inhibitors, gonadotrophin releasing hormone (GnRH) agonists/antagonists, and antiandrogens",
"criterion": "hormone therapy-based regimen",
"requirement": {
"requirement_type": "currently treated",
"expected_value": true
}
},
{
"exact_snippets": "concurrent anti-HER2 therapy and other targeted therapy (e.g., CDK4/6 inhibitor, mTOR inhibitor) is permitted",
"criterion": "concurrent anti-HER2 therapy and other targeted therapy",
"requirement": {
"requirement_type": "permitted",
"expected_value": true
}
},
{
"exact_snippets": "must have started the current regimen at least 4 weeks prior to enrollment",
"criterion": "current regimen start time",
"requirement": {
"requirement_type": "time since start",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Currently treated with hormone therapy-based regimen, including selective estrogen receptor modulators (SERMs), aromatase inhibitors, selective estrogen receptor down regulators (SERDs), CYP17A1 inhibitors, gonadotrophin releasing hormone (GnRH) agonists/antagonists, and antiandrogens",
"criterion": "hormone therapy-based regimen",
"requirement": {
"requirement_type": "currently treated",
"expected_value": true
}
},
{
"exact_snippets": "must have started the current regimen at least 4 weeks prior to enrollment",
"criterion": "current regimen start time",
"requirement": {
"requirement_type": "time since start",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
{
"exact_snippets": "concurrent anti-HER2 therapy and other targeted therapy (e.g., CDK4/6 inhibitor, mTOR inhibitor) is permitted",
"criterion": "concurrent anti-HER2 therapy and other targeted therapy",
"requirement": {
"requirement_type": "permitted",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* A response of at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired) to the question ?how tired did you feel in the past week??",
"criterions": [
{
"exact_snippets": "A response of at least 4 on a 10 point scale ... to the question ?how tired did you feel in the past week??",
"criterion": "tiredness",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 4,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "A response of at least 4 on a 10 point scale ... to the question ?how tired did you feel in the past week??",
"criterion": "tiredness",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 4,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Sedentary activity pattern (Average < 90 minutes per week of moderate-to-vigorous intensity sports activity based on patient self-report) within the past year",
"criterions": [
{
"exact_snippets": "Sedentary activity pattern (Average < 90 minutes per week of moderate-to-vigorous intensity sports activity",
"criterion": "sedentary activity pattern",
"requirement": {
"requirement_type": "average weekly activity",
"expected_value": {
"operator": "<",
"value": 90,
"unit": "minutes"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Sedentary activity pattern (Average < 90 minutes per week of moderate-to-vigorous intensity sports activity",
"criterion": "sedentary activity pattern",
"requirement": {
"requirement_type": "average weekly activity",
"expected_value": {
"operator": "<",
"value": 90,
"unit": "minutes"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Physically able to exercise and physician consent to start an exercise program",
"criterions": [
{
"exact_snippets": "Physically able to exercise",
"criterion": "physical ability to exercise",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "physician consent to start an exercise program",
"criterion": "physician consent for exercise program",
"requirement": {
"requirement_type": "consent",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Physically able to exercise",
"criterion": "physical ability to exercise",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "physician consent to start an exercise program",
"criterion": "physician consent for exercise program",
"requirement": {
"requirement_type": "consent",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Regular access to a computer with internet service",
"criterions": [
{
"exact_snippets": "Regular access to a computer",
"criterion": "computer access",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "internet service",
"criterion": "internet access",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Regular access to a computer",
"criterion": "computer access",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "internet service",
"criterion": "internet access",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Must be able to read and understand English",
"criterions": [
{
"exact_snippets": "Must be able to read and understand English",
"criterion": "English language proficiency",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be able to read and understand English",
"criterion": "English language proficiency",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines",
"criterions": [
{
"exact_snippets": "Able to provide informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "willing to sign an approved consent form",
"criterion": "consent form signing",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Able to provide informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "willing to sign an approved consent form",
"criterion": "consent form signing",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Evidence of disease progression at the time of enrollment",
"criterions": [
{
"exact_snippets": "Evidence of disease progression",
"criterion": "disease progression",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Evidence of disease progression",
"criterion": "disease progression",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Treatment with cytotoxic chemotherapy within 3 months prior to enrollment",
"criterions": [
{
"exact_snippets": "Treatment with cytotoxic chemotherapy within 3 months prior to enrollment",
"criterion": "cytotoxic chemotherapy treatment",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Treatment with cytotoxic chemotherapy within 3 months prior to enrollment",
"criterion": "cytotoxic chemotherapy treatment",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
}
}
},
{
"identified_line": {
"line": "* Prior cognitive-behavioral therapy",
"criterions": [
{
"exact_snippets": "Prior cognitive-behavioral therapy",
"criterion": "cognitive-behavioral therapy",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Prior cognitive-behavioral therapy",
"criterion": "cognitive-behavioral therapy",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}