{
"info": {
"nct_id": "NCT03707548",
"official_title": "A Clinical Trial of Group-based Body Psychotherapy (BPT) to Improve Bodily Disturbances in Post-treatment Cancer Patients in Combination With Randomized Controlled Smartphone-triggered Bodily Interventions",
"inclusion_criteria": "* Having received curatively intended treatment for any malignant neoplasm; primary treatment (surgery, radiotherapy, chemotherapy) being completed >/= 3 months ago before study inclusion. Any other ongoing anti-tumor therapy is allowed (e.g., hormonal therapy, adjuvant immunotherapy)\n* existing bodily disturbances\n* No sign of progress or recurrence of malignancy at study inclusion according to treating physician\n* Score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) Performance Score\n* Having an anticipated life expectancy of >/= 12 months, according to treating physician\n* age 18 years or older\n* Capacity to participate in group BPT sessions in Basel or Winterthur, 3 study assessments, and the smartphone-triggered interventions\n* Ability to provide informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Suffering from a severe current mental disorder\n* Risk of current suicidality, as indicated by a suicide item score >/= 2 in the BDI-II (Beck Depression Inventory), as this group BPT intervention is not appropriate to support suicidal patients in acute crises\n* Participation in any other clinical trial with a psychosocial intervention\n* Receiving any other current psychotherapeutic treatment with the exception of already established therapies\n* Inability to understand and speak German",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Having received curatively intended treatment for any malignant neoplasm; primary treatment (surgery, radiotherapy, chemotherapy) being completed >/= 3 months ago before study inclusion. Any other ongoing anti-tumor therapy is allowed (e.g., hormonal therapy, adjuvant immunotherapy)",
"criterions": [
{
"exact_snippets": "Having received curatively intended treatment for any malignant neoplasm",
"criterion": "curatively intended treatment for malignant neoplasm",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "primary treatment (surgery, radiotherapy, chemotherapy) being completed >/= 3 months ago before study inclusion",
"criterion": "completion of primary treatment",
"requirement": {
"requirement_type": "time since completion",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
},
{
"exact_snippets": "Any other ongoing anti-tumor therapy is allowed (e.g., hormonal therapy, adjuvant immunotherapy)",
"criterion": "ongoing anti-tumor therapy",
"requirement": {
"requirement_type": "allowance",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Having received curatively intended treatment for any malignant neoplasm",
"criterion": "curatively intended treatment for malignant neoplasm",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "primary treatment (surgery, radiotherapy, chemotherapy) being completed >/= 3 months ago before study inclusion",
"criterion": "completion of primary treatment",
"requirement": {
"requirement_type": "time since completion",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
},
{
"exact_snippets": "Any other ongoing anti-tumor therapy is allowed (e.g., hormonal therapy, adjuvant immunotherapy)",
"criterion": "ongoing anti-tumor therapy",
"requirement": {
"requirement_type": "allowance",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* existing bodily disturbances",
"criterions": [
{
"exact_snippets": "existing bodily disturbances",
"criterion": "bodily disturbances",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "existing bodily disturbances",
"criterion": "bodily disturbances",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* No sign of progress or recurrence of malignancy at study inclusion according to treating physician",
"criterions": [
{
"exact_snippets": "No sign of progress or recurrence of malignancy",
"criterion": "progress or recurrence of malignancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "according to treating physician",
"criterion": "treating physician's assessment",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No sign of progress or recurrence of malignancy",
"criterion": "progress or recurrence of malignancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "according to treating physician",
"criterion": "treating physician's assessment",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) Performance Score",
"criterions": [
{
"exact_snippets": "Score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) Performance Score",
"criterion": "ECOG Performance Score",
"requirement": {
"requirement_type": "score",
"expected_value": {
"comparisons": [
{
"operator": "=",
"value": 0,
"unit": "N/A"
},
{
"operator": "=",
"value": 1,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) Performance Score",
"criterion": "ECOG Performance Score",
"requirement": {
"requirement_type": "score",
"expected_value": {
"comparisons": [
{
"operator": "=",
"value": 0,
"unit": "N/A"
},
{
"operator": "=",
"value": 1,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Having an anticipated life expectancy of >/= 12 months, according to treating physician",
"criterions": [
{
"exact_snippets": "anticipated life expectancy of >/= 12 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "anticipated life expectancy of >/= 12 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* age 18 years or older",
"criterions": [
{
"exact_snippets": "age 18 years or older",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "age 18 years or older",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Capacity to participate in group BPT sessions in Basel or Winterthur, 3 study assessments, and the smartphone-triggered interventions",
"criterions": [
{
"exact_snippets": "Capacity to participate in group BPT sessions in Basel or Winterthur",
"criterion": "capacity to participate in group BPT sessions",
"requirement": {
"requirement_type": "location",
"expected_value": [
"Basel",
"Winterthur"
]
}
},
{
"exact_snippets": "Capacity to participate in ... 3 study assessments",
"criterion": "capacity to participate in study assessments",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "=",
"value": 3,
"unit": "assessments"
}
}
},
{
"exact_snippets": "Capacity to participate in ... smartphone-triggered interventions",
"criterion": "capacity to participate in smartphone-triggered interventions",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Capacity to participate in group BPT sessions in Basel or Winterthur",
"criterion": "capacity to participate in group BPT sessions",
"requirement": {
"requirement_type": "location",
"expected_value": [
"Basel",
"Winterthur"
]
}
},
{
"exact_snippets": "Capacity to participate in ... 3 study assessments",
"criterion": "capacity to participate in study assessments",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "=",
"value": 3,
"unit": "assessments"
}
}
}
]
},
{
"exact_snippets": "Capacity to participate in ... smartphone-triggered interventions",
"criterion": "capacity to participate in smartphone-triggered interventions",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Ability to provide informed consent",
"criterions": [
{
"exact_snippets": "Ability to provide informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Ability to provide informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"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 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Suffering from a severe current mental disorder",
"criterions": [
{
"exact_snippets": "Suffering from a severe current mental disorder",
"criterion": "mental disorder",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Suffering from a severe current mental disorder",
"criterion": "mental disorder",
"requirement": {
"requirement_type": "temporal",
"expected_value": "current"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Suffering from a severe current mental disorder",
"criterion": "mental disorder",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Suffering from a severe current mental disorder",
"criterion": "mental disorder",
"requirement": {
"requirement_type": "temporal",
"expected_value": "current"
}
}
]
}
},
{
"identified_line": {
"line": "* Risk of current suicidality, as indicated by a suicide item score >/= 2 in the BDI-II (Beck Depression Inventory), as this group BPT intervention is not appropriate to support suicidal patients in acute crises",
"criterions": [
{
"exact_snippets": "Risk of current suicidality, as indicated by a suicide item score >/= 2 in the BDI-II (Beck Depression Inventory)",
"criterion": "suicidality",
"requirement": {
"requirement_type": "risk",
"expected_value": true
}
},
{
"exact_snippets": "suicide item score >/= 2 in the BDI-II (Beck Depression Inventory)",
"criterion": "suicide item score",
"requirement": {
"requirement_type": "value",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Risk of current suicidality, as indicated by a suicide item score >/= 2 in the BDI-II (Beck Depression Inventory)",
"criterion": "suicidality",
"requirement": {
"requirement_type": "risk",
"expected_value": true
}
},
{
"exact_snippets": "suicide item score >/= 2 in the BDI-II (Beck Depression Inventory)",
"criterion": "suicide item score",
"requirement": {
"requirement_type": "value",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Participation in any other clinical trial with a psychosocial intervention",
"criterions": [
{
"exact_snippets": "Participation in any other clinical trial with a psychosocial intervention",
"criterion": "participation in other clinical trial",
"requirement": {
"requirement_type": "intervention type",
"expected_value": "psychosocial"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Participation in any other clinical trial with a psychosocial intervention",
"criterion": "participation in other clinical trial",
"requirement": {
"requirement_type": "intervention type",
"expected_value": "psychosocial"
}
}
}
},
{
"identified_line": {
"line": "* Receiving any other current psychotherapeutic treatment with the exception of already established therapies",
"criterions": [
{
"exact_snippets": "Receiving any other current psychotherapeutic treatment",
"criterion": "current psychotherapeutic treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "with the exception of already established therapies",
"criterion": "already established therapies",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "with the exception of already established therapies",
"criterion": "already established therapies",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": null,
"else_criteria": {
"exact_snippets": "Receiving any other current psychotherapeutic treatment",
"criterion": "current psychotherapeutic treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Inability to understand and speak German",
"criterions": [
{
"exact_snippets": "Inability to understand and speak German",
"criterion": "German language proficiency",
"requirement": {
"requirement_type": "proficiency",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Inability to understand and speak German",
"criterion": "German language proficiency",
"requirement": {
"requirement_type": "proficiency",
"expected_value": false
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}