{
"info": {
"nct_id": "NCT05354882",
"official_title": "Interventional Study on DEterminants and Factors of Physical ACtivity After Treatments in Oncology",
"inclusion_criteria": "* 18 years ≤ age < 75 years\n* survivors of primary non-metastatic breast, lung, prostate or colorectal cancer (stage I, II or III and primary, second and relapse included)\n* 3 weeks to 20 years post-treatment (surgery, chemotherapy, radiation therapy and/or immunotherapy) not including hormonal therapy\n* Whose ability to participate in the APA intervention has been certified by a medical certificate issued by physician\n* Availability and willingness to invest in the DEFACTO study during the program (3 months) and during the post-program follow-up (12 months)\n* Participating, on average, in no more than 150 minutes of moderate physical activity or no more than 75 minutes of vigorous activity per week\n* Average at least 6 hours a day of sedentary behaviours\n* Able to read, understand and complete questionnaires in French\n* Able to use connected device (Vivosmart4®) and to perform simple operating actions (press a button, recharge the battery)\n* possessing a smartphone which can download Garmin Connect application ®\n* Able to walk unassisted\n* French speaking and living in France\n* having signed the consent form\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* Current evidence of metastatic disease\n* Having an absolute contraindication by a physician to practice PA\n* Using treatments that influence blood pressure, cardiotoxic drugs, painkillers (morphinics);\n* Using cane or walking aid\n* Deprived of liberty by judicial or administrative decision\n* Person under guardianship or curatorship\n* Pregnancy and/or lactating women\n* Being diagnosed of any cardiac abnormalities",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* survivors of primary non-metastatic breast, lung, prostate or colorectal cancer (stage I, II or III and primary, second and relapse included)",
"criterions": [
{
"exact_snippets": "survivors of primary non-metastatic breast, lung, prostate or colorectal cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "types",
"expected_value": [
"breast",
"lung",
"prostate",
"colorectal"
]
}
},
{
"exact_snippets": "non-metastatic",
"criterion": "cancer metastasis",
"requirement": {
"requirement_type": "metastasis",
"expected_value": false
}
},
{
"exact_snippets": "stage I, II or III",
"criterion": "cancer stage",
"requirement": {
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"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "stage"
},
{
"operator": "<=",
"value": 3,
"unit": "stage"
}
]
}
}
},
{
"exact_snippets": "primary, second and relapse included",
"criterion": "cancer occurrence",
"requirement": {
"requirement_type": "occurrence",
"expected_value": [
"primary",
"second",
"relapse"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "survivors of primary non-metastatic breast, lung, prostate or colorectal cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "types",
"expected_value": [
"breast",
"lung",
"prostate",
"colorectal"
]
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"expected_value": false
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},
{
"exact_snippets": "stage I, II or III",
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{
"operator": ">=",
"value": 1,
"unit": "stage"
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{
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}
]
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{
"exact_snippets": "primary, second and relapse included",
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"primary",
"second",
"relapse"
]
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* 3 weeks to 20 years post-treatment (surgery, chemotherapy, radiation therapy and/or immunotherapy) not including hormonal therapy",
"criterions": [
{
"exact_snippets": "3 weeks to 20 years post-treatment (surgery, chemotherapy, radiation therapy and/or immunotherapy)",
"criterion": "time since treatment",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "weeks"
},
{
"operator": "<=",
"value": 20,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "not including hormonal therapy",
"criterion": "treatment type",
"requirement": {
"requirement_type": "exclusion",
"expected_value": "hormonal therapy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "3 weeks to 20 years post-treatment (surgery, chemotherapy, radiation therapy and/or immunotherapy)",
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"requirement": {
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"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "weeks"
},
{
"operator": "<=",
"value": 20,
"unit": "years"
}
]
}
}
},
{
"not_criteria": {
"exact_snippets": "not including hormonal therapy",
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}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Whose ability to participate in the APA intervention has been certified by a medical certificate issued by physician",
"criterions": [
{
"exact_snippets": "ability to participate in the APA intervention ... certified by a medical certificate issued by physician",
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"expected_value": true
}
}
]
},
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"exact_snippets": "ability to participate in the APA intervention ... certified by a medical certificate issued by physician",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Availability and willingness to invest in the DEFACTO study during the program (3 months) and during the post-program follow-up (12 months)",
"criterions": [
{
"exact_snippets": "Availability and willingness to invest in the DEFACTO study during the program (3 months) and during the post-program follow-up (12 months)",
"criterion": "availability",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Availability and willingness to invest in the DEFACTO study during the program (3 months) and during the post-program follow-up (12 months)",
"criterion": "willingness",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Availability and willingness to invest in the DEFACTO study during the program (3 months) and during the post-program follow-up (12 months)",
"criterion": "availability",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Availability and willingness to invest in the DEFACTO study during the program (3 months) and during the post-program follow-up (12 months)",
"criterion": "willingness",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Participating, on average, in no more than 150 minutes of moderate physical activity",
"criterion": "moderate physical activity",
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"operator": "<=",
"value": 150,
"unit": "minutes per week"
}
}
},
{
"exact_snippets": "no more than 75 minutes of vigorous activity per week",
"criterion": "vigorous physical activity",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 75,
"unit": "minutes per week"
}
}
}
]
},
"logical_structure": {
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{
"and_criteria": [
{
"exact_snippets": "Participating, on average, in no more than 150 minutes of moderate physical activity",
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"unit": "minutes per week"
}
}
}
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},
{
"and_criteria": [
{
"exact_snippets": "no more than 75 minutes of vigorous activity per week",
"criterion": "vigorous physical activity",
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"operator": "<=",
"value": 75,
"unit": "minutes per week"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Average at least 6 hours a day of sedentary behaviours",
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{
"exact_snippets": "Average at least 6 hours a day of sedentary behaviours",
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"operator": ">=",
"value": 6,
"unit": "hours per day"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Average at least 6 hours a day of sedentary behaviours",
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"unit": "hours per day"
}
}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Able to read ... in French",
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"expected_value": "French"
}
},
{
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},
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},
{
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},
{
"identified_line": {
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}
},
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},
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}
}
]
}
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{
"identified_line": {
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{
"exact_snippets": "Able to walk unassisted",
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}
}
]
},
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}
}
]
}
},
{
"identified_line": {
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{
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},
{
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}
}
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}
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{
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]
}
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"identified_line": {
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{
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},
{
"identified_line": {
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]
}
},
{
"identified_line": {
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{
"exact_snippets": "minimum age of 18 Years",
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"operator": ">=",
"value": 18,
"unit": "Years"
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}
}
]
},
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"exact_snippets": "minimum age of 18 Years",
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "maximum age of 75 Years",
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"unit": "Years"
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}
}
]
},
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"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Able to use connected device (Vivosmart4®) and to perform simple operating actions (press a button, recharge the battery)",
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"exact_snippets": "Able to use connected device (Vivosmart4®)",
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}
},
{
"exact_snippets": "able ... to perform simple operating actions (press a button, recharge the battery)",
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}
}
]
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}
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"exact_snippets": "able ... to perform simple operating actions (press a button, recharge the battery)",
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]
}
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],
"exclusion_lines": [
{
"identified_line": {
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}
}
},
{
"identified_line": {
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"exact_snippets": "Using treatments that influence blood pressure",
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}
},
{
"exact_snippets": "cardiotoxic drugs",
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"exact_snippets": "painkillers (morphinics)",
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"exact_snippets": "Using treatments that influence blood pressure",
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"exact_snippets": "painkillers (morphinics)",
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]
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"identified_line": {
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]
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},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Deprived of liberty by judicial or administrative decision",
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}
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},
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}
}
}
},
{
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{
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},
{
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]
}
},
{
"identified_line": {
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{
"exact_snippets": "Pregnancy",
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}
},
{
"exact_snippets": "lactating women",
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}
},
{
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}
},
{
"identified_line": {
"line": "* Being diagnosed of any cardiac abnormalities",
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{
"exact_snippets": "Being diagnosed of any cardiac abnormalities",
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}
}
]
},
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}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* 18 years ≤ age < 75 years",
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{
"exact_snippets": "18 years ≤ age < 75 years",
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{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<",
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"unit": "years"
}
]
}
}
}
]
},
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{
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"unit": "years"
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{
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"unit": "years"
}
]
}
}
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}