{
    "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": [
        {
            "line": "* Men and women age 65 years and older",
            "criterions": [
                {
                    "exact_snippets": "Men and women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "age 65 years and older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 65,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "cancer (hematologic or solid)",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "hematologic",
                                "solid"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "cancer ... at stage considered amenable to cure",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "curability",
                            "expected_value": "amenable to cure"
                        }
                    ]
                },
                {
                    "exact_snippets": "as assessed by the treating MD",
                    "criterion": "assessment by treating MD",
                    "requirements": [
                        {
                            "requirement_type": "assessor",
                            "expected_value": "treating MD"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "all participants must have had chemotherapy treatment",
                    "criterion": "chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "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",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "allowed"
                        }
                    ]
                },
                {
                    "exact_snippets": "hormonal therapy in males with prostate cancer",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "see exclusion criteria"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Moderate to severe fatigue (>4 on BFI)",
            "criterions": [
                {
                    "exact_snippets": "Moderate to severe fatigue (>4 on BFI)",
                    "criterion": "fatigue",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "BFI"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Less than 120 minutes/week of physical activity",
            "criterions": [
                {
                    "exact_snippets": "Less than 120 minutes/week of physical activity",
                    "criterion": "physical activity",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 120,
                                "unit": "minutes/week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* English speaking",
            "criterions": [
                {
                    "exact_snippets": "English speaking",
                    "criterion": "language",
                    "requirements": [
                        {
                            "requirement_type": "proficiency",
                            "expected_value": "English"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed IRB approved written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Signed IRB approved written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "signed"
                        },
                        {
                            "requirement_type": "approval",
                            "expected_value": "IRB approved"
                        },
                        {
                            "requirement_type": "format",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "engage in moderate-intensity physical activity",
                    "criterion": "ability to engage in moderate-intensity physical activity",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient-assessed ability to walk and engage in moderate physical activity",
            "criterions": [
                {
                    "exact_snippets": "Patient-assessed ability to walk",
                    "criterion": "ability to walk",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "patient-assessed"
                        }
                    ]
                },
                {
                    "exact_snippets": "engage in moderate physical activity",
                    "criterion": "ability to engage in moderate physical activity",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "patient-assessed"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 65 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Receiving hormonal therapy for prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Receiving hormonal therapy for prostate cancer",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "prostate cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to walk or engage in moderate-intensity physical activity",
            "criterions": [
                {
                    "exact_snippets": "Unable to walk",
                    "criterion": "ability to walk",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "engage in moderate-intensity physical activity",
                    "criterion": "ability to engage in moderate-intensity physical activity",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have BFI≤3.",
            "criterions": [
                {
                    "exact_snippets": "BFI≤3",
                    "criterion": "BFI",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Report more than 120 minutes/week of physical activity",
            "criterions": [
                {
                    "exact_snippets": "more than 120 minutes/week of physical activity",
                    "criterion": "physical activity",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 120,
                                "unit": "minutes/week"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}