{
"info": {
"nct_id": "NCT01952860",
"official_title": "A Feasibility Study of Hatha Yoga in Couples Coping With Lung Cancer",
"inclusion_criteria": "1. Patients with non-small cell lung cancer (NSCLC) stages I through IIIB who are going to receive at least 5 weeks of thoracic radiation therapy with or without chemotherapy undergoing daily radiation treatment in the Department of Radiation Oncology at M. D. Anderson Cancer Center (MDACC) and an eligible and consenting caregiving partner.\n2. Patients and caregiving partners must both be at least 18 years old.\n3. Participants have a study eligible and consenting caregiving partner spouse or significant other (e.g, romantic partner). (i.e. spouse, romantic/domestic partners, significant others).\n4. Patients and caregiving partners should be able to read, write, and speak English.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Patients who are not oriented to time, place, and person.\n2. Patients who have practiced Tibetan or Hatha yoga in the year prior to diagnosis on a regular basis.\n3. Lung cancer patients with a life expectancy of less than 6 months per attending physician estimation.\n4. Lung cancer patients with the attending physician-rated Eastern Cooperative Oncology Group (ECOG) performance status score of greater than 2 at the time of radiotherapy initiation.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Patients with non-small cell lung cancer (NSCLC) stages I through IIIB who are going to receive at least 5 weeks of thoracic radiation therapy with or without chemotherapy undergoing daily radiation treatment in the Department of Radiation Oncology at M. D. Anderson Cancer Center (MDACC) and an eligible and consenting caregiving partner.",
"criterions": [
{
"exact_snippets": "non-small cell lung cancer (NSCLC)",
"criterion": "non-small cell lung cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "stages I through IIIB",
"criterion": "cancer stage",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "stage"
},
{
"operator": "<=",
"value": 3,
"unit": "stage"
}
]
}
}
]
},
{
"exact_snippets": "at least 5 weeks of thoracic radiation therapy",
"criterion": "thoracic radiation therapy duration",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "with or without chemotherapy",
"criterion": "chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "optional"
}
]
},
{
"exact_snippets": "daily radiation treatment",
"criterion": "radiation treatment frequency",
"requirements": [
{
"requirement_type": "frequency",
"expected_value": "daily"
}
]
},
{
"exact_snippets": "Department of Radiation Oncology at M. D. Anderson Cancer Center (MDACC)",
"criterion": "treatment location",
"requirements": [
{
"requirement_type": "location",
"expected_value": "Department of Radiation Oncology at M. D. Anderson Cancer Center (MDACC)"
}
]
},
{
"exact_snippets": "eligible and consenting caregiving partner",
"criterion": "caregiving partner",
"requirements": [
{
"requirement_type": "eligibility and consent",
"expected_value": true
}
]
}
]
},
{
"line": "2. Patients and caregiving partners must both be at least 18 years old.",
"criterions": [
{
"exact_snippets": "Patients ... must ... be at least 18 years old.",
"criterion": "patient age",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
},
{
"exact_snippets": "caregiving partners must ... be at least 18 years old.",
"criterion": "caregiving partner age",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "3. Participants have a study eligible and consenting caregiving partner spouse or significant other (e.g, romantic partner). (i.e. spouse, romantic/domestic partners, significant others).",
"criterions": [
{
"exact_snippets": "Participants have a study eligible and consenting caregiving partner spouse or significant other",
"criterion": "caregiving partner",
"requirements": [
{
"requirement_type": "eligibility",
"expected_value": "study eligible"
},
{
"requirement_type": "consent",
"expected_value": true
}
]
}
]
},
{
"line": "4. Patients and caregiving partners should be able to read, write, and speak English.",
"criterions": [
{
"exact_snippets": "Patients and caregiving partners should be able to read ... English.",
"criterion": "English reading ability",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "Patients and caregiving partners should be able to ... write ... English.",
"criterion": "English writing ability",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "Patients and caregiving partners should be able to ... speak English.",
"criterion": "English speaking ability",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"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"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. Patients who are not oriented to time, place, and person.",
"criterions": [
{
"exact_snippets": "not oriented to time, place, and person",
"criterion": "orientation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "2. Patients who have practiced Tibetan or Hatha yoga in the year prior to diagnosis on a regular basis.",
"criterions": [
{
"exact_snippets": "Patients who have practiced Tibetan or Hatha yoga",
"criterion": "yoga practice",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"Tibetan",
"Hatha"
]
}
]
},
{
"exact_snippets": "in the year prior to diagnosis",
"criterion": "yoga practice",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "year prior to diagnosis"
}
]
},
{
"exact_snippets": "on a regular basis",
"criterion": "yoga practice",
"requirements": [
{
"requirement_type": "frequency",
"expected_value": "regular basis"
}
]
}
]
},
{
"line": "3. Lung cancer patients with a life expectancy of less than 6 months per attending physician estimation.",
"criterions": [
{
"exact_snippets": "Lung cancer patients",
"criterion": "lung cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "life expectancy of less than 6 months",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 6,
"unit": "months"
}
}
]
}
]
},
{
"line": "4. Lung cancer patients with the attending physician-rated Eastern Cooperative Oncology Group (ECOG) performance status score of greater than 2 at the time of radiotherapy initiation.",
"criterions": [
{
"exact_snippets": "Lung cancer patients",
"criterion": "lung cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "attending physician-rated Eastern Cooperative Oncology Group (ECOG) performance status score of greater than 2",
"criterion": "ECOG performance status score",
"requirements": [
{
"requirement_type": "score",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "N/A"
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}