{
"info": {
"nct_id": "NCT06442891",
"official_title": "A Pilot Study of Self-Administered Acupressure for Fatigue Among Adolescent and Young Adult (AYA) Cancer Survivors",
"inclusion_criteria": "* 15 - 39 years old\n* At least three months post cancer treatment (e.g., surgery, radiation or chemotherapy). Participants receiving maintenance hormonal or targeted therapies will be allowed to enroll as determined by the study investigator\n* Report clinically relevant fatigue in the past seven days (Patient Reported Outcomes Measurement Information Systems [PROMIS] Fatigue 4a scores ≥ 55)\n* Speak / read English\n* CRF started at or after the diagnosis of cancer\n* Completed cancer treatment within the past five years\nHealthy volunteers allowed\nMust have minimum age of 15 Years\nMust have maximum age of 39 Years",
"exclusion_criteria": "* Diagnosis of untreated anemia, mood disorder, or hypothyroidism\n* Plan to begin new pharmacological, psychological, or other treatments (i.e., physical therapy or dietary supplements) for CRF during the study. Although, participants may continue usual treatments for CRF if the treatments were initiated at least eight weeks prior to study enrollment, and the dose has not changed\n* Plan to become pregnant or lactating during the study period\n* Received acupressure or acupuncture in the past year",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* 15 - 39 years old",
"criterions": [
{
"exact_snippets": "15 - 39 years old",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 15,
"unit": "years"
},
{
"operator": "<=",
"value": 39,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "15 - 39 years old",
"criterion": "age",
"requirement": {
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{
"operator": ">=",
"value": 15,
"unit": "years"
},
{
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"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* At least three months post cancer treatment (e.g., surgery, radiation or chemotherapy). Participants receiving maintenance hormonal or targeted therapies will be allowed to enroll as determined by the study investigator",
"criterions": [
{
"exact_snippets": "At least three months post cancer treatment",
"criterion": "time since cancer treatment",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
},
{
"exact_snippets": "Participants receiving maintenance hormonal or targeted therapies will be allowed to enroll",
"criterion": "maintenance hormonal or targeted therapies",
"requirement": {
"requirement_type": "enrollment eligibility",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "At least three months post cancer treatment",
"criterion": "time since cancer treatment",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
},
{
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{
"exact_snippets": "Participants receiving maintenance hormonal or targeted therapies will be allowed to enroll",
"criterion": "maintenance hormonal or targeted therapies",
"requirement": {
"requirement_type": "enrollment eligibility",
"expected_value": true
}
},
{
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"exact_snippets": "Participants receiving maintenance hormonal or targeted therapies will be allowed to enroll",
"criterion": "maintenance hormonal or targeted therapies",
"requirement": {
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"expected_value": true
}
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}
]
}
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}
]
}
},
{
"identified_line": {
"line": "* Report clinically relevant fatigue in the past seven days (Patient Reported Outcomes Measurement Information Systems [PROMIS] Fatigue 4a scores ≥ 55)",
"criterions": [
{
"exact_snippets": "clinically relevant fatigue in the past seven days",
"criterion": "clinically relevant fatigue",
"requirement": {
"requirement_type": "time frame",
"expected_value": "past seven days"
}
},
{
"exact_snippets": "Patient Reported Outcomes Measurement Information Systems [PROMIS] Fatigue 4a scores ≥ 55",
"criterion": "PROMIS Fatigue 4a scores",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": ">=",
"value": 55,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "clinically relevant fatigue in the past seven days",
"criterion": "clinically relevant fatigue",
"requirement": {
"requirement_type": "time frame",
"expected_value": "past seven days"
}
},
{
"exact_snippets": "Patient Reported Outcomes Measurement Information Systems [PROMIS] Fatigue 4a scores ≥ 55",
"criterion": "PROMIS Fatigue 4a scores",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": ">=",
"value": 55,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Speak / read English",
"criterions": [
{
"exact_snippets": "Speak / read English",
"criterion": "English language proficiency",
"requirement": {
"requirement_type": "ability",
"expected_value": [
"speak",
"read"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Speak / read English",
"criterion": "English language proficiency",
"requirement": {
"requirement_type": "ability",
"expected_value": [
"speak",
"read"
]
}
}
]
}
},
{
"identified_line": {
"line": "* CRF started at or after the diagnosis of cancer",
"criterions": [
{
"exact_snippets": "CRF started at or after the diagnosis of cancer",
"criterion": "CRF",
"requirement": {
"requirement_type": "start time",
"expected_value": "at or after the diagnosis of cancer"
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "CRF started at or after the diagnosis of cancer",
"criterion": "CRF",
"requirement": {
"requirement_type": "start time",
"expected_value": "at or after the diagnosis of cancer"
}
}
]
}
},
{
"identified_line": {
"line": "* Completed cancer treatment within the past five years",
"criterions": [
{
"exact_snippets": "Completed cancer treatment within the past five years",
"criterion": "cancer treatment completion",
"requirement": {
"requirement_type": "time since completion",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Completed cancer treatment within the past five years",
"criterion": "cancer treatment completion",
"requirement": {
"requirement_type": "time since completion",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "years"
}
}
}
]
}
},
{
"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 15 Years",
"criterions": [
{
"exact_snippets": "minimum age of 15 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 15,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 15 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 15,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 39 Years",
"criterions": [
{
"exact_snippets": "maximum age of 39 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 39,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 39 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 39,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Diagnosis of untreated anemia, mood disorder, or hypothyroidism",
"criterions": [
{
"exact_snippets": "Diagnosis of untreated anemia",
"criterion": "anemia",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "untreated"
}
},
{
"exact_snippets": "Diagnosis of ... mood disorder",
"criterion": "mood disorder",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosis of ... hypothyroidism",
"criterion": "hypothyroidism",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
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"criterion": "anemia",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "untreated"
}
},
{
"exact_snippets": "Diagnosis of ... mood disorder",
"criterion": "mood disorder",
"requirement": {
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"expected_value": true
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{
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"criterion": "hypothyroidism",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Plan to begin new pharmacological, psychological, or other treatments (i.e., physical therapy or dietary supplements) for CRF during the study. Although, participants may continue usual treatments for CRF if the treatments were initiated at least eight weeks prior to study enrollment, and the dose has not changed",
"criterions": [
{
"exact_snippets": "Plan to begin new pharmacological, psychological, or other treatments (i.e., physical therapy or dietary supplements) for CRF during the study.",
"criterion": "new treatments for CRF",
"requirement": {
"requirement_type": "plan to begin",
"expected_value": false
}
},
{
"exact_snippets": "participants may continue usual treatments for CRF if the treatments were initiated at least eight weeks prior to study enrollment, and the dose has not changed",
"criterion": "usual treatments for CRF",
"requirement": {
"requirement_type": "initiation time",
"expected_value": {
"operator": ">=",
"value": 8,
"unit": "weeks"
}
}
},
{
"exact_snippets": "participants may continue usual treatments for CRF if the treatments were initiated at least eight weeks prior to study enrollment, and the dose has not changed",
"criterion": "usual treatments for CRF",
"requirement": {
"requirement_type": "dose change",
"expected_value": false
}
}
]
},
"logical_structure": {
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"requirement": {
"requirement_type": "plan to begin",
"expected_value": false
}
}
},
{
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"criterion": "usual treatments for CRF",
"requirement": {
"requirement_type": "initiation time",
"expected_value": {
"operator": ">=",
"value": 8,
"unit": "weeks"
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"exact_snippets": "participants may continue usual treatments for CRF if the treatments were initiated at least eight weeks prior to study enrollment, and the dose has not changed",
"criterion": "usual treatments for CRF",
"requirement": {
"requirement_type": "dose change",
"expected_value": false
}
}
]
}
}
]
}
},
{
"identified_line": {
"line": "* Received acupressure or acupuncture in the past year",
"criterions": [
{
"exact_snippets": "Received acupressure",
"criterion": "acupressure",
"requirement": {
"requirement_type": "received",
"expected_value": true
}
},
{
"exact_snippets": "Received acupressure",
"criterion": "acupressure",
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"expected_value": "past year"
}
},
{
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"criterion": "acupuncture",
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"expected_value": true
}
},
{
"exact_snippets": "Received ... acupuncture",
"criterion": "acupuncture",
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]
},
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"and_criteria": [
{
"exact_snippets": "Received acupressure",
"criterion": "acupressure",
"requirement": {
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"expected_value": true
}
},
{
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"expected_value": "past year"
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}
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{
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"criterion": "acupuncture",
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"expected_value": true
}
},
{
"exact_snippets": "Received ... acupuncture",
"criterion": "acupuncture",
"requirement": {
"requirement_type": "time frame",
"expected_value": "past year"
}
}
]
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* Plan to become pregnant or lactating during the study period",
"criterions": [
{
"exact_snippets": "Plan to become pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "intention",
"expected_value": false
}
},
{
"exact_snippets": "lactating during the study period",
"criterion": "lactation",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
}
]
},
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"exact_snippets": "Plan to become pregnant",
"criterion": "pregnancy",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "lactating during the study period",
"criterion": "lactation",
"requirement": {
"requirement_type": "status",
"expected_value": true
}
}
]
}
}
],
"failed_miscellaneous": []
}