{
"info": {
"nct_id": "NCT02191982",
"official_title": "A Randomized, Wait-list Controlled Clinical Trial: the Effect of a Physical Activity Program on Fatigue After Potentially Curative Chemotherapy Among Cancer Survivors Age 65 or Older -- PACT (Physical Activity After Chemotherapy)",
"inclusion_criteria": "* Men and women age 65 years and older\n* Histologically or cytologically confirmed cancer (hematologic or solid) at stage considered amenable to cure as assessed by the treating MD\n* Within 6 weeks of end of chemotherapy (all participants must have had chemotherapy treatment)\n\n * Any radiation received must also be completed prior to randomization (if radiation treatment follows adjuvant chemotherapy, then the patient must be recruited within 6 weeks of end of radiation)\n * Maintenance hormonal therapy in women with breast cancer is allowed; see exclusion criteria regarding hormonal therapy in males with prostate cancer\n* Moderate to severe fatigue (>4 on BFI)\n* Less than 120 minutes/week of physical activity\n* English speaking\n* Signed IRB approved written informed consent\n* Approval from their treating physician to engage in moderate-intensity physical activity\n* Patient-assessed ability to walk and engage in moderate physical activity\n* Willing and able to meet all study requirements.\nHealthy volunteers allowed\nMust have minimum age of 65 Years",
"exclusion_criteria": "* Receiving hormonal therapy for prostate cancer\n* Unable to walk or engage in moderate-intensity physical activity\n* Have BFI≤3.\n* Report more than 120 minutes/week of physical activity",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Men and women age 65 years and older",
"criterions": [
{
"exact_snippets": "Men and women",
"criterion": "gender",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"male",
"female"
]
}
},
{
"exact_snippets": "age 65 years and older",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 65,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Men and women",
"criterion": "gender",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"male",
"female"
]
}
},
{
"exact_snippets": "age 65 years and older",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 65,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Histologically or cytologically confirmed cancer (hematologic or solid) at stage considered amenable to cure as assessed by the treating MD",
"criterions": [
{
"exact_snippets": "Histologically or cytologically confirmed cancer",
"criterion": "cancer confirmation",
"requirement": {
"requirement_type": "method",
"expected_value": [
"histologically",
"cytologically"
]
}
},
{
"exact_snippets": "cancer (hematologic or solid)",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": [
"hematologic",
"solid"
]
}
},
{
"exact_snippets": "cancer ... at stage considered amenable to cure",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "curability",
"expected_value": "amenable to cure"
}
},
{
"exact_snippets": "as assessed by the treating MD",
"criterion": "assessment by treating MD",
"requirement": {
"requirement_type": "assessor",
"expected_value": "treating MD"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Histologically or cytologically confirmed cancer",
"criterion": "cancer confirmation",
"requirement": {
"requirement_type": "method",
"expected_value": [
"histologically",
"cytologically"
]
}
},
{
"exact_snippets": "cancer (hematologic or solid)",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": [
"hematologic",
"solid"
]
}
}
]
},
{
"exact_snippets": "cancer ... at stage considered amenable to cure",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "curability",
"expected_value": "amenable to cure"
}
}
]
},
{
"exact_snippets": "as assessed by the treating MD",
"criterion": "assessment by treating MD",
"requirement": {
"requirement_type": "assessor",
"expected_value": "treating MD"
}
}
]
}
},
{
"identified_line": {
"line": "* Within 6 weeks of end of chemotherapy (all participants must have had chemotherapy treatment)",
"criterions": [
{
"exact_snippets": "Within 6 weeks of end of chemotherapy",
"criterion": "time since end of chemotherapy",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "weeks"
}
}
},
{
"exact_snippets": "all participants must have had chemotherapy treatment",
"criterion": "chemotherapy treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Within 6 weeks of end of chemotherapy",
"criterion": "time since end of chemotherapy",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "weeks"
}
}
},
{
"exact_snippets": "all participants must have had chemotherapy treatment",
"criterion": "chemotherapy treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Any radiation received must also be completed prior to randomization (if radiation treatment follows adjuvant chemotherapy, then the patient must be recruited within 6 weeks of end of radiation)",
"criterions": [
{
"exact_snippets": "Any radiation received must also be completed prior to randomization",
"criterion": "radiation treatment",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "if radiation treatment follows adjuvant chemotherapy, then the patient must be recruited within 6 weeks of end of radiation",
"criterion": "recruitment timing",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "weeks"
}
]
}
}
}
]
},
"logical_structure": {
"condition": {
"and_criteria": [
{
"exact_snippets": "Any radiation received must also be completed prior to randomization",
"criterion": "radiation treatment",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "if radiation treatment follows adjuvant chemotherapy, then the patient must be recruited within 6 weeks of end of radiation",
"criterion": "radiation treatment follows adjuvant chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"then_criteria": {
"exact_snippets": "if radiation treatment follows adjuvant chemotherapy, then the patient must be recruited within 6 weeks of end of radiation",
"criterion": "recruitment timing",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "weeks"
}
]
}
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Maintenance hormonal therapy in women with breast cancer is allowed; see exclusion criteria regarding hormonal therapy in males with prostate cancer",
"criterions": [
{
"exact_snippets": "Maintenance hormonal therapy in women with breast cancer is allowed",
"criterion": "maintenance hormonal therapy",
"requirement": {
"requirement_type": "eligibility",
"expected_value": "allowed"
}
},
{
"exact_snippets": "hormonal therapy in males with prostate cancer",
"criterion": "hormonal therapy",
"requirement": {
"requirement_type": "eligibility",
"expected_value": "see exclusion criteria"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Maintenance hormonal therapy in women with breast cancer is allowed",
"criterion": "maintenance hormonal therapy",
"requirement": {
"requirement_type": "eligibility",
"expected_value": "allowed"
}
},
{
"exact_snippets": "hormonal therapy in males with prostate cancer",
"criterion": "hormonal therapy",
"requirement": {
"requirement_type": "eligibility",
"expected_value": "see exclusion criteria"
}
}
]
}
},
{
"identified_line": {
"line": "* Moderate to severe fatigue (>4 on BFI)",
"criterions": [
{
"exact_snippets": "Moderate to severe fatigue (>4 on BFI)",
"criterion": "fatigue",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "BFI"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Moderate to severe fatigue (>4 on BFI)",
"criterion": "fatigue",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "BFI"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Less than 120 minutes/week of physical activity",
"criterions": [
{
"exact_snippets": "Less than 120 minutes/week of physical activity",
"criterion": "physical activity",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 120,
"unit": "minutes/week"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Less than 120 minutes/week of physical activity",
"criterion": "physical activity",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 120,
"unit": "minutes/week"
}
}
}
]
}
},
{
"identified_line": {
"line": "* English speaking",
"criterions": [
{
"exact_snippets": "English speaking",
"criterion": "language",
"requirement": {
"requirement_type": "proficiency",
"expected_value": "English"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "English speaking",
"criterion": "language",
"requirement": {
"requirement_type": "proficiency",
"expected_value": "English"
}
}
]
}
},
{
"identified_line": {
"line": "* Signed IRB approved written informed consent",
"criterions": [
{
"exact_snippets": "Signed IRB approved written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "status",
"expected_value": "signed"
}
},
{
"exact_snippets": "Signed IRB approved written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "approval",
"expected_value": "IRB approved"
}
},
{
"exact_snippets": "Signed IRB approved written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "format",
"expected_value": "written"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Signed IRB approved written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "status",
"expected_value": "signed"
}
},
{
"exact_snippets": "Signed IRB approved written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "approval",
"expected_value": "IRB approved"
}
},
{
"exact_snippets": "Signed IRB approved written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "format",
"expected_value": "written"
}
}
]
}
},
{
"identified_line": {
"line": "* Approval from their treating physician to engage in moderate-intensity physical activity",
"criterions": [
{
"exact_snippets": "Approval from their treating physician",
"criterion": "approval from treating physician",
"requirement": {
"requirement_type": "approval",
"expected_value": true
}
},
{
"exact_snippets": "engage in moderate-intensity physical activity",
"criterion": "ability to engage in moderate-intensity physical activity",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Approval from their treating physician",
"criterion": "approval from treating physician",
"requirement": {
"requirement_type": "approval",
"expected_value": true
}
},
{
"exact_snippets": "engage in moderate-intensity physical activity",
"criterion": "ability to engage in moderate-intensity physical activity",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patient-assessed ability to walk and engage in moderate physical activity",
"criterions": [
{
"exact_snippets": "Patient-assessed ability to walk",
"criterion": "ability to walk",
"requirement": {
"requirement_type": "assessment",
"expected_value": "patient-assessed"
}
},
{
"exact_snippets": "engage in moderate physical activity",
"criterion": "ability to engage in moderate physical activity",
"requirement": {
"requirement_type": "assessment",
"expected_value": "patient-assessed"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient-assessed ability to walk",
"criterion": "ability to walk",
"requirement": {
"requirement_type": "assessment",
"expected_value": "patient-assessed"
}
},
{
"exact_snippets": "engage in moderate physical activity",
"criterion": "ability to engage in moderate physical activity",
"requirement": {
"requirement_type": "assessment",
"expected_value": "patient-assessed"
}
}
]
}
},
{
"identified_line": {
"line": "* Willing and able to meet all study requirements.",
"criterions": [
{
"exact_snippets": "Willing and able to meet all study requirements.",
"criterion": "willingness and ability to meet study requirements",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Willing and able to meet all study requirements.",
"criterion": "willingness and ability to meet study requirements",
"requirement": {
"requirement_type": "presence",
"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"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 65 Years",
"criterions": [
{
"exact_snippets": "minimum age of 65 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 65,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 65 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 65,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Receiving hormonal therapy for prostate cancer",
"criterions": [
{
"exact_snippets": "Receiving hormonal therapy for prostate cancer",
"criterion": "hormonal therapy",
"requirement": {
"requirement_type": "condition",
"expected_value": "prostate cancer"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Receiving hormonal therapy for prostate cancer",
"criterion": "hormonal therapy",
"requirement": {
"requirement_type": "condition",
"expected_value": "prostate cancer"
}
}
]
}
},
{
"identified_line": {
"line": "* Unable to walk or engage in moderate-intensity physical activity",
"criterions": [
{
"exact_snippets": "Unable to walk",
"criterion": "ability to walk",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
},
{
"exact_snippets": "engage in moderate-intensity physical activity",
"criterion": "ability to engage in moderate-intensity physical activity",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Unable to walk",
"criterion": "ability to walk",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
},
{
"exact_snippets": "engage in moderate-intensity physical activity",
"criterion": "ability to engage in moderate-intensity physical activity",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Have BFI≤3.",
"criterions": [
{
"exact_snippets": "BFI≤3",
"criterion": "BFI",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "BFI≤3",
"criterion": "BFI",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "N/A"
}
}
}
}
},
{
"identified_line": {
"line": "* Report more than 120 minutes/week of physical activity",
"criterions": [
{
"exact_snippets": "more than 120 minutes/week of physical activity",
"criterion": "physical activity",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 120,
"unit": "minutes/week"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "more than 120 minutes/week of physical activity",
"criterion": "physical activity",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 120,
"unit": "minutes/week"
}
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}