{
"info": {
"nct_id": "NCT05056831",
"official_title": "Efficacy of an Adapted Multicomponent Physical Activity Intervention to Reduce Psychosocial Distress in Rural Adults Following Cancer Diagnosis",
"inclusion_criteria": "* PROVIDERS: Work with cancer survivors (e.g., radiation and medical oncologists, oncology nurses, oncology patient navigators, and clinical research coordinators)\n* PROVIDERS: Place of engagement falls within a rural county in Texas\n* PROVIDERS: Able to read, speak, and write in English\n* PROVIDERS: At least 18 years old\n* PROVIDERS: Have access to a smartphone, tablet, or computer with internet access and willing to attend virtual sessions\n* INTERVIEW SURVIVORS: Men and women >= 18 years of age\n* INTERVIEW SURVIVORS: History of cancer\n* INTERVIEW SURVIVORS: Currently receiving treatment or have recently completed treatment but are still attending appointments at UTHealth North Campus Tyler (=< 1 year)\n* INTERVIEW SURVIVORS: Able to read, speak, and write in English\n* INTERVIEW SURVIVORS: Have access to a smartphone, tablet, or computer with internet access and willing to attend virtual sessions\n* INTERVENTION SURVIVORS: Men and women >= 18 years of age\n* INTERVENTION SURVIVORS: Received a solid tumor cancer diagnosis stage I-III\n* INTERVENTION SURVIVORS: Receiving radiation therapy or planning to receive radiation therapy for a solid tumor diagnosis for at least 4 weeks\n* INTERVENTION SURVIVORS: Able to engage in moderate intensity physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q) or by physicians clearance (letter from physician or nurse practitioner)\n* INTERVENTION SURVIVORS: Physician clearance to participate in the study\n* INTERVENTION SURVIVORS: Physically inactive (=< 60 minutes of moderate or greater physical activity [PA] per week during the past 6 months)\n* INTERVENTION SURVIVORS: Live within MD Anderson's rural catchment area\n* INTERVENTION SURVIVORS: Have a home address where information can be mailed and a working telephone\n* INTERVENTION SURVIVORS: Have access to a smartphone, tablet, or computer with internet access and willing to attend virtual sessions\n* INTERVENTION SURVIVORS: Able to read, speak, and write in English\n* INTERVENTION SURVIVORS: Able to receive text messages on their smartphone (via cellular data or wireless internet)\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* PROVIDERS: Does not work with cancer survivors\n* PROVIDERS: Place of work or engagement falls within an urban/metropolitan county in Texas\n* PROVIDERS: Does not read, speak, or write in English\n* PROVIDERS: Below the age of 18 years\n* INTERVIEW SURVIVORS: No history of cancer\n* INTERVIEW SURVIVORS: Does not read, speak, or write in English\n* INTERVIEW SURVIVORS: Below the age of 18\n* INTERVENTION SURVIVORS: No history of cancer\n* INTERVENTION SURVIVORS: Have absolute contraindications to unassisted physical activity (e.g., acute myocardial infarction, severe orthopedic or musculoskeletal limitations)\n* INTERVENTION SURVIVORS: Currently participating in another intervention to increase physical activity or reduce sedentary behavior\n* INTERVENTION SURVIVORS: Self-report meeting physical activity recommendations (>= 60 minutes of moderate or greater PA per week during the past 6 months)\n* INTERVENTION SURVIVORS: Physical limitations that might be aggravated by participation in moderate-intensity physical activity as measured using the Physical Activity Readiness Questionnaire (PAR-Q), and any physical limitation that prevents engaging in moderate intensity exercise\n* INTERVENTION SURVIVORS: Primary address falls within an urban/metropolitan county in Texas\n* INTERVENTION SURVIVORS: Plan to move from the area or discontinue their treatment at UTHealth North Campus Tyler during the 14-week study period\n* INTERVETION SURVIVORS: Does not read, speak, or write in English\n* INTERVENTION SURVIVORS: Below the age of 18\n* INTERVENTION SURVIVORS: Pregnant or planning to become pregnant during the 14 week study period",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* PROVIDERS: Work with cancer survivors (e.g., radiation and medical oncologists, oncology nurses, oncology patient navigators, and clinical research coordinators)",
"criterions": [
{
"exact_snippets": "cancer survivors",
"criterion": "provider experience",
"requirement": {
"requirement_type": "experience",
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},
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"exact_snippets": "radiation and medical oncologists",
"criterion": "provider type",
"requirement": {
"requirement_type": "type",
"expected_value": "radiation oncologists"
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{
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"criterion": "provider type",
"requirement": {
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}
},
{
"exact_snippets": "oncology nurses",
"criterion": "provider type",
"requirement": {
"requirement_type": "type",
"expected_value": "oncology nurses"
}
},
{
"exact_snippets": "oncology patient navigators",
"criterion": "provider type",
"requirement": {
"requirement_type": "type",
"expected_value": "oncology patient navigators"
}
},
{
"exact_snippets": "clinical research coordinators",
"criterion": "provider type",
"requirement": {
"requirement_type": "type",
"expected_value": "clinical research coordinators"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
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]
}
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{
"identified_line": {
"line": "* PROVIDERS: Place of engagement falls within a rural county in Texas",
"criterions": [
{
"exact_snippets": "Place of engagement falls within a rural county in Texas",
"criterion": "place of engagement",
"requirement": {
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}
}
]
},
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"and_criteria": [
{
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}
]
}
},
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"identified_line": {
"line": "* PROVIDERS: Able to read, speak, and write in English",
"criterions": [
{
"exact_snippets": "Able to read, speak, and write in English",
"criterion": "English language proficiency",
"requirement": {
"requirement_type": "reading ability",
"expected_value": true
}
},
{
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"criterion": "English language proficiency",
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}
},
{
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}
]
},
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}
},
{
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"criterion": "English language proficiency",
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},
{
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}
]
}
},
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"identified_line": {
"line": "* PROVIDERS: At least 18 years old",
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{
"exact_snippets": "At least 18 years old",
"criterion": "age",
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"operator": ">=",
"value": 18,
"unit": "years"
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"operator": ">=",
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"unit": "years"
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}
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]
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},
{
"identified_line": {
"line": "* PROVIDERS: Have access to a smartphone, tablet, or computer with internet access and willing to attend virtual sessions",
"criterions": [
{
"exact_snippets": "Have access to a smartphone, tablet, or computer with internet access",
"criterion": "access to a smartphone, tablet, or computer with internet access",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "willing to attend virtual sessions",
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}
},
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}
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{
"identified_line": {
"line": "* INTERVIEW SURVIVORS: Men and women >= 18 years of age",
"criterions": [
{
"exact_snippets": "Men and women",
"criterion": "gender",
"requirement": {
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"expected_value": [
"men",
"women"
]
}
},
{
"exact_snippets": ">= 18 years of age",
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"operator": ">=",
"value": 18,
"unit": "years"
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}
}
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"women"
]
}
},
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* INTERVIEW SURVIVORS: History of cancer",
"criterions": [
{
"exact_snippets": "History of cancer",
"criterion": "cancer history",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
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}
]
}
},
{
"identified_line": {
"line": "* INTERVIEW SURVIVORS: Currently receiving treatment or have recently completed treatment but are still attending appointments at UTHealth North Campus Tyler (=< 1 year)",
"criterions": [
{
"exact_snippets": "Currently receiving treatment",
"criterion": "treatment status",
"requirement": {
"requirement_type": "status",
"expected_value": "currently receiving"
}
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{
"exact_snippets": "have recently completed treatment",
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"requirement": {
"requirement_type": "status",
"expected_value": "recently completed"
}
},
{
"exact_snippets": "still attending appointments at UTHealth North Campus Tyler (=< 1 year)",
"criterion": "appointment attendance",
"requirement": {
"requirement_type": "location",
"expected_value": "UTHealth North Campus Tyler"
}
},
{
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"criterion": "appointment attendance",
"requirement": {
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"operator": "<=",
"value": 1,
"unit": "year"
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}
}
]
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]
}
},
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"identified_line": {
"line": "* INTERVIEW SURVIVORS: Have access to a smartphone, tablet, or computer with internet access and willing to attend virtual sessions",
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},
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},
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"and_criteria": [
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}
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},
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]
}
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"identified_line": {
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{
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"unit": "years"
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},
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
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}
}
]
}
},
{
"identified_line": {
"line": "* INTERVENTION SURVIVORS: Received a solid tumor cancer diagnosis stage I-III",
"criterions": [
{
"exact_snippets": "solid tumor cancer diagnosis",
"criterion": "solid tumor cancer diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "stage I-III",
"criterion": "cancer stage",
"requirement": {
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"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
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"exact_snippets": "solid tumor cancer diagnosis",
"criterion": "solid tumor cancer diagnosis",
"requirement": {
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}
},
{
"exact_snippets": "stage I-III",
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"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
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"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
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]
}
}
}
]
}
},
{
"identified_line": {
"line": "* INTERVENTION SURVIVORS: Receiving radiation therapy or planning to receive radiation therapy for a solid tumor diagnosis for at least 4 weeks",
"criterions": [
{
"exact_snippets": "Receiving radiation therapy",
"criterion": "radiation therapy",
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"expected_value": true
}
},
{
"exact_snippets": "planning to receive radiation therapy",
"criterion": "radiation therapy",
"requirement": {
"requirement_type": "planned",
"expected_value": true
}
},
{
"exact_snippets": "solid tumor diagnosis",
"criterion": "solid tumor diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "at least 4 weeks",
"criterion": "radiation therapy duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
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"or_criteria": [
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}
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{
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"line": "* INTERVENTION SURVIVORS: Able to engage in moderate intensity physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q) or by physicians clearance (letter from physician or nurse practitioner)",
"criterions": [
{
"exact_snippets": "Able to engage in moderate intensity physical activity",
"criterion": "physical activity capability",
"requirement": {
"requirement_type": "intensity",
"expected_value": "moderate"
}
},
{
"exact_snippets": "as determined by the Physical Activity Readiness Questionnaire (PAR-Q)",
"criterion": "PAR-Q determination",
"requirement": {
"requirement_type": "determination",
"expected_value": "required"
}
},
{
"exact_snippets": "or by physicians clearance (letter from physician or nurse practitioner)",
"criterion": "physician's clearance",
"requirement": {
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"expected_value": "required"
}
}
]
},
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{
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]
}
},
{
"identified_line": {
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{
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"requirement_type": "approval",
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}
}
]
},
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}
}
]
}
},
{
"identified_line": {
"line": "* INTERVENTION SURVIVORS: Physically inactive (=< 60 minutes of moderate or greater physical activity [PA] per week during the past 6 months)",
"criterions": [
{
"exact_snippets": "Physically inactive (=< 60 minutes of moderate or greater physical activity [PA] per week during the past 6 months)",
"criterion": "physical activity",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
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"unit": "minutes per week"
}
]
}
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{
"exact_snippets": "Physically inactive (=< 60 minutes of moderate or greater physical activity [PA] per week during the past 6 months)",
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}
]
},
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}
]
}
},
{
"identified_line": {
"line": "* INTERVENTION SURVIVORS: Live within MD Anderson's rural catchment area",
"criterions": [
{
"exact_snippets": "Live within MD Anderson's rural catchment area",
"criterion": "residence location",
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"requirement_type": "location",
"expected_value": "MD Anderson's rural catchment area"
}
}
]
},
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{
"exact_snippets": "Live within MD Anderson's rural catchment area",
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}
}
]
}
},
{
"identified_line": {
"line": "* INTERVENTION SURVIVORS: Have a home address where information can be mailed and a working telephone",
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{
"exact_snippets": "Have a home address where information can be mailed",
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"requirement_type": "availability",
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}
},
{
"exact_snippets": "a working telephone",
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"requirement": {
"requirement_type": "functionality",
"expected_value": true
}
}
]
},
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}
},
{
"exact_snippets": "a working telephone",
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"requirement_type": "functionality",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* INTERVENTION SURVIVORS: Have access to a smartphone, tablet, or computer with internet access and willing to attend virtual sessions",
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{
"exact_snippets": "Have access to a smartphone, tablet, or computer",
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"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "with internet access",
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"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "willing to attend virtual sessions",
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"requirement": {
"requirement_type": "willingness",
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}
}
]
},
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}
},
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}
}
]
},
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},
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}
]
}
},
{
"identified_line": {
"line": "* INTERVENTION SURVIVORS: Able to read, speak, and write in English",
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{
"exact_snippets": "Able to read",
"criterion": "language ability",
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"requirement_type": "reading",
"expected_value": "English"
}
},
{
"exact_snippets": "speak",
"criterion": "language ability",
"requirement": {
"requirement_type": "speaking",
"expected_value": "English"
}
},
{
"exact_snippets": "write in English",
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"requirement": {
"requirement_type": "writing",
"expected_value": "English"
}
}
]
},
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{
"exact_snippets": "Able to read",
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"expected_value": "English"
}
},
{
"exact_snippets": "speak",
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"requirement": {
"requirement_type": "speaking",
"expected_value": "English"
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},
{
"exact_snippets": "write in English",
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"requirement": {
"requirement_type": "writing",
"expected_value": "English"
}
}
]
}
},
{
"identified_line": {
"line": "* INTERVENTION SURVIVORS: Able to receive text messages on their smartphone (via cellular data or wireless internet)",
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{
"exact_snippets": "Able to receive text messages on their smartphone (via cellular data or wireless internet)",
"criterion": "smartphone text message reception",
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"requirement_type": "capability",
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}
]
},
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{
"exact_snippets": "Able to receive text messages on their smartphone (via cellular data or wireless internet)",
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"requirement_type": "capability",
"expected_value": true
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}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
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{
"exact_snippets": "Healthy volunteers allowed",
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"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"
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}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
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"exact_snippets": "minimum age of 18 Years",
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"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
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}
}
]
},
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"exact_snippets": "minimum age of 18 Years",
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"operator": ">=",
"value": 18,
"unit": "Years"
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}
}
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}
}
],
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"identified_line": {
"line": "* PROVIDERS: Does not work with cancer survivors",
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"exact_snippets": "Does not work with cancer survivors",
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"requirement_type": "presence",
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}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Does not work with cancer survivors",
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"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* PROVIDERS: Place of work or engagement falls within an urban/metropolitan county in Texas",
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"exact_snippets": "Place of work or engagement falls within an urban/metropolitan county in Texas",
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},
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}
}
},
{
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},
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}
},
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"value": 18,
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}
}
]
},
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"operator": "<",
"value": 18,
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}
}
}
},
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"identified_line": {
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]
},
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}
}
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"identified_line": {
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"exact_snippets": "Below the age of 18",
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"requirement_type": "range",
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"operator": "<",
"value": 18,
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},
"logical_structure": {
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},
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}
}
},
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"identified_line": {
"line": "* INTERVENTION SURVIVORS: Have absolute contraindications to unassisted physical activity (e.g., acute myocardial infarction, severe orthopedic or musculoskeletal limitations)",
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"exact_snippets": "absolute contraindications to unassisted physical activity",
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"requirement_type": "presence",
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},
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"exact_snippets": "acute myocardial infarction",
"criterion": "acute myocardial infarction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
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},
{
"exact_snippets": "severe orthopedic or musculoskeletal limitations",
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"requirement_type": "severity",
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},
"logical_structure": {
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"and_criteria": [
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"exact_snippets": "acute myocardial infarction",
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},
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"exact_snippets": "severe orthopedic or musculoskeletal limitations",
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"identified_line": {
"line": "* INTERVENTION SURVIVORS: Currently participating in another intervention to increase physical activity or reduce sedentary behavior",
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"exact_snippets": "Currently participating in another intervention to increase physical activity",
"criterion": "participation in physical activity intervention",
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"exact_snippets": "Currently participating in another intervention to ... reduce sedentary behavior",
"criterion": "participation in sedentary behavior reduction intervention",
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"requirement_type": "presence",
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},
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"exact_snippets": "Currently participating in another intervention to increase physical activity",
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]
}
},
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"identified_line": {
"line": "* INTERVENTION SURVIVORS: Self-report meeting physical activity recommendations (>= 60 minutes of moderate or greater PA per week during the past 6 months)",
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"exact_snippets": "Self-report meeting physical activity recommendations (>= 60 minutes of moderate or greater PA per week during the past 6 months)",
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"requirement_type": "self-report",
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},
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"operator": ">=",
"value": 60,
"unit": "minutes per week"
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}
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{
"exact_snippets": "Self-report meeting physical activity recommendations (>= 60 minutes of moderate or greater PA per week during the past 6 months)",
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"requirement": {
"requirement_type": "intensity",
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}
},
{
"exact_snippets": "Self-report meeting physical activity recommendations (>= 60 minutes of moderate or greater PA per week during the past 6 months)",
"criterion": "physical activity",
"requirement": {
"requirement_type": "time frame",
"expected_value": "past 6 months"
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}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
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}
]
}
},
{
"identified_line": {
"line": "* INTERVENTION SURVIVORS: Physical limitations that might be aggravated by participation in moderate-intensity physical activity as measured using the Physical Activity Readiness Questionnaire (PAR-Q), and any physical limitation that prevents engaging in moderate intensity exercise",
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"exact_snippets": "Physical limitations that might be aggravated by participation in moderate-intensity physical activity",
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"requirement_type": "aggravation risk",
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},
{
"exact_snippets": "any physical limitation that prevents engaging in moderate intensity exercise",
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},
"logical_structure": {
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"and_criteria": [
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"exact_snippets": "Physical limitations that might be aggravated by participation in moderate-intensity physical activity",
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"expected_value": true
}
},
{
"exact_snippets": "any physical limitation that prevents engaging in moderate intensity exercise",
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"requirement_type": "prevention of exercise",
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]
}
]
}
},
{
"identified_line": {
"line": "* INTERVENTION SURVIVORS: Primary address falls within an urban/metropolitan county in Texas",
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"exact_snippets": "Primary address falls within an urban/metropolitan county in Texas",
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"expected_value": "urban/metropolitan county in Texas"
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}
}
},
{
"identified_line": {
"line": "* INTERVENTION SURVIVORS: Plan to move from the area or discontinue their treatment at UTHealth North Campus Tyler during the 14-week study period",
"criterions": [
{
"exact_snippets": "Plan to move from the area",
"criterion": "residency stability",
"requirement": {
"requirement_type": "stability",
"expected_value": false
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},
{
"exact_snippets": "discontinue their treatment at UTHealth North Campus Tyler during the 14-week study period",
"criterion": "treatment continuity",
"requirement": {
"requirement_type": "continuity",
"expected_value": true
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}
]
},
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"exact_snippets": "Plan to move from the area",
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"expected_value": false
}
},
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"exact_snippets": "discontinue their treatment at UTHealth North Campus Tyler during the 14-week study period",
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"requirement_type": "continuity",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* INTERVETION SURVIVORS: Does not read, speak, or write in English",
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"exact_snippets": "Does not read, speak, or write in English",
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]
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"criterion": "English language proficiency",
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"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* INTERVENTION SURVIVORS: Below the age of 18",
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{
"exact_snippets": "Below the age of 18",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 18,
"unit": "years"
}
]
}
}
}
]
},
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"criterion": "age",
"requirement": {
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{
"operator": "<",
"value": 18,
"unit": "years"
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]
}
}
}
}
},
{
"identified_line": {
"line": "* INTERVENTION SURVIVORS: Pregnant or planning to become pregnant during the 14 week study period",
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{
"exact_snippets": "Pregnant",
"criterion": "pregnancy status",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "planning to become pregnant during the 14 week study period",
"criterion": "pregnancy plans",
"requirement": {
"requirement_type": "intention",
"expected_value": false
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]
},
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"and_criteria": [
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"exact_snippets": "Pregnant",
"criterion": "pregnancy status",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "planning to become pregnant during the 14 week study period",
"criterion": "pregnancy plans",
"requirement": {
"requirement_type": "intention",
"expected_value": false
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}