{
    "info": {
        "nct_id": "NCT05442957",
        "official_title": "A Multi-Site, Parallel-Group, Randomized Clinical Trial Comparing a Brief Tele-Cognitive Behavioral Therapy Intervention (BRIGHT) With Attention Control for the Reduction of Body Image-Related Distress Among Head and Neck Cancer Survivors",
        "inclusion_criteria": "1. Age > 18 years on the day of informed consent\n2. History of pathologically confirmed squamous cell carcinoma (or histologic variant) of the oral cavity, pharynx, larynx, nose/paranasal sinuses, carcinoma of a major or minor salivary gland, or cutaneous malignancy of the face or neck\n3. History of curative intent surgery with or without adjuvant therapy, with or without reconstruction\n4. Completion of oncologic treatment within 12 months of study enrollment (but no sooner than 6 weeks post-treatment completion)\n5. Cancer-free at the time of accrual\n\n   -patients with known indolent malignancies (e.g., non-melanoma skin cancer, low risk thyroid cancer, untreated prostate cancer, etc) would not exclude a patient from the study\n6. No planned significant HNC ablative or reconstructive surgery (defined by a postoperative inpatient stay of at least three days) during the study intervention or follow-up period as determined by the HNC oncologic surgeon at the time of study accrual\n7. Willingness to be randomized to either BRIGHT or AC\n8. IMAGE-HN score > 22\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Inability to speak or write English\n2. Pre-existing, ongoing CBT services for other disorders and the participant is not willing to discontinue the prior therapy for the duration of the proposed trial\n3. Initiation or adjustment (< 3 months of baseline) of psychotropic medication\n4. Severe psychiatric comorbidity (e.g., suicidal ideation, psychosis)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age > 18 years on the day of informed consent",
            "criterions": [
                {
                    "exact_snippets": "Age > 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. History of pathologically confirmed squamous cell carcinoma (or histologic variant) of the oral cavity, pharynx, larynx, nose/paranasal sinuses, carcinoma of a major or minor salivary gland, or cutaneous malignancy of the face or neck",
            "criterions": [
                {
                    "exact_snippets": "History of pathologically confirmed squamous cell carcinoma (or histologic variant)",
                    "criterion": "squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "oral cavity, pharynx, larynx, nose/paranasal sinuses",
                    "criterion": "location of squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "oral cavity",
                                "pharynx",
                                "larynx",
                                "nose",
                                "paranasal sinuses"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinoma of a major or minor salivary gland",
                    "criterion": "carcinoma of salivary gland",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "major salivary gland",
                                "minor salivary gland"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "cutaneous malignancy of the face or neck",
                    "criterion": "cutaneous malignancy",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "face",
                                "neck"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. History of curative intent surgery with or without adjuvant therapy, with or without reconstruction",
            "criterions": [
                {
                    "exact_snippets": "History of curative intent surgery",
                    "criterion": "curative intent surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "with or without adjuvant therapy",
                    "criterion": "adjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "with",
                                "without"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "with or without reconstruction",
                    "criterion": "reconstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "with",
                                "without"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Completion of oncologic treatment within 12 months of study enrollment (but no sooner than 6 weeks post-treatment completion)",
            "criterions": [
                {
                    "exact_snippets": "Completion of oncologic treatment within 12 months of study enrollment",
                    "criterion": "oncologic treatment completion",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no sooner than 6 weeks post-treatment completion",
                    "criterion": "oncologic treatment completion",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Cancer-free at the time of accrual",
            "criterions": [
                {
                    "exact_snippets": "Cancer-free at the time of accrual",
                    "criterion": "cancer status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "cancer-free"
                        }
                    ]
                }
            ]
        },
        {
            "line": "-patients with known indolent malignancies (e.g., non-melanoma skin cancer, low risk thyroid cancer, untreated prostate cancer, etc) would not exclude a patient from the study",
            "criterions": [
                {
                    "exact_snippets": "known indolent malignancies (e.g., non-melanoma skin cancer, low risk thyroid cancer, untreated prostate cancer, etc)",
                    "criterion": "indolent malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. No planned significant HNC ablative or reconstructive surgery (defined by a postoperative inpatient stay of at least three days) during the study intervention or follow-up period as determined by the HNC oncologic surgeon at the time of study accrual",
            "criterions": [
                {
                    "exact_snippets": "No planned significant HNC ablative or reconstructive surgery",
                    "criterion": "planned significant HNC ablative or reconstructive surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "postoperative inpatient stay of at least three days",
                    "criterion": "postoperative inpatient stay",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "during the study intervention or follow-up period",
                    "criterion": "timing of surgery",
                    "requirements": [
                        {
                            "requirement_type": "period",
                            "expected_value": [
                                "study intervention",
                                "follow-up period"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Willingness to be randomized to either BRIGHT or AC",
            "criterions": [
                {
                    "exact_snippets": "Willingness to be randomized to either BRIGHT or AC",
                    "criterion": "willingness to be randomized",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. IMAGE-HN score > 22",
            "criterions": [
                {
                    "exact_snippets": "IMAGE-HN score > 22",
                    "criterion": "IMAGE-HN score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 22,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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. Inability to speak or write English",
            "criterions": [
                {
                    "exact_snippets": "Inability to speak or write English",
                    "criterion": "English language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Pre-existing, ongoing CBT services for other disorders and the participant is not willing to discontinue the prior therapy for the duration of the proposed trial",
            "criterions": [
                {
                    "exact_snippets": "Pre-existing, ongoing CBT services for other disorders",
                    "criterion": "CBT services for other disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "participant is not willing to discontinue the prior therapy for the duration of the proposed trial",
                    "criterion": "willingness to discontinue prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Initiation or adjustment (< 3 months of baseline) of psychotropic medication",
            "criterions": [
                {
                    "exact_snippets": "Initiation or adjustment (< 3 months of baseline) of psychotropic medication",
                    "criterion": "psychotropic medication",
                    "requirements": [
                        {
                            "requirement_type": "initiation or adjustment",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months of baseline"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Severe psychiatric comorbidity (e.g., suicidal ideation, psychosis)",
            "criterions": [
                {
                    "exact_snippets": "Severe psychiatric comorbidity (e.g., suicidal ideation, psychosis)",
                    "criterion": "psychiatric comorbidity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}