Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-02 @ 1:30 AM
Study NCT ID:
NCT02821793
Status:
COMPLETED
Last Update Posted:
2025-07-01
First Post:
2016-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Expectations and Priorities of Elderly Patients for a First Medical Treatment for Cancer
Sponsor:
Organization:
Raw JSON
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'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012017', 'term': 'Referral and Consultation'}], 'ancestors': [{'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 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[{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Autonomy', 'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Daily tasks', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Social activities', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Burden of treatment', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Toxicity', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Economic burden', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 initiation of 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[{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Toxicity', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Economic burden', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months after initiation of treatment', 'description': 'Prioritization among of the 4 items selected from a list of 8 expectations regarding the objectives of their treatment : treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden.\n\nFor each expectation, the number and rate of priorization are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients without major deviation on study protocol and eligibility criteria who indicated at least one 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'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Quite', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'A lot', 'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Life expectancy', 'categories': [{'title': 'Not at all', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'A little', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderately', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Quite', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'A lot', 'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Autonomy', 'categories': [{'title': 'Not at all', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'A little', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderately', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Quite', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'A lot', 'measurements': [{'value': '178', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Daily tasks', 'categories': [{'title': 'Not at all', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'A 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[{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Quite', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'A lot', 'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Life expectancy', 'categories': [{'title': 'Not at all', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'A little', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Moderately', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Quite', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'A lot', 'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Autonomy', 'categories': [{'title': 'Not at all', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'A little', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Moderately', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Quite', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': 'A lot', 'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Daily tasks', 'categories': [{'title': 'Not at all', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'A little', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderately', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Quite', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'A lot', 'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Social activities', 'categories': [{'title': 'Not at all', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'A little', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Moderately', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Quite', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': 'A lot', 'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Burden of treatment', 'categories': [{'title': 'Not at all', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'A little', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Moderately', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Quite', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'A lot', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Toxicity', 'categories': [{'title': 'Not at all', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'A little', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Moderately', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Quite', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'title': 'A lot', 'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Economic burden', 'categories': [{'title': 'Not at all', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': 'A little', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderately', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Quite', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'A lot', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months after initiation of treatment', 'description': 'Patients had to rate on a 5-point Likert scale (not at all / a little / moderately / quite / a lot) their expectations for treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients without major deviation on study protocol and eligibility criteria who indicated at least one priority in the prioritization grid 3 months after initiation of treatment'}, {'type': 'SECONDARY', 'title': 'Stability of Patients in Their Priorities at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elderly Patient (70 Years and Older)', 'description': 'Geriatric consultation, evaluation questionnaire: Geriatric consultation, evaluation questionnaire'}, {'id': 'OG001', 'title': 'Young Patient (18 Years - 69 Years)', 'description': 'Consultation, evaluation questionnaire: Consultation, evaluation questionnaire'}], 'classes': [{'title': 'Treatment efficacy', 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Life expectancy', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Autonomy', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Daily tasks', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Social activities', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Burden of treatment', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Toxicity', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Economic burden', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months after initiation of treatment', 'description': 'For each expectation, stability is defined as the prioritization of the expectation at treatment initiation and 3 months after treatment initiation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients without major deviation on study protocol and eligibility criteria who indicated at least one priority in the prioritization grid at the initiation of treatment and 3 months after treatment initiation'}, {'type': 'SECONDARY', 'title': '1-year Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elderly Patient (70 Years and Older)', 'description': 'Geriatric consultation, evaluation questionnaire: Geriatric consultation, evaluation questionnaire'}, {'id': 'OG001', 'title': 'Young Patient (18 Years - 69 Years)', 'description': 'Consultation, evaluation questionnaire: Consultation, evaluation questionnaire'}], 'classes': [{'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000', 'lowerLimit': '71.4', 'upperLimit': '83.0'}, {'value': '85.2', 'groupId': 'OG001', 'lowerLimit': '76.2', 'upperLimit': '90.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From inclusion to the end of study', 'description': 'Overall survival is defined as the time between the date of inclusion and the date of death, whatever the cause.\n\nThe rate of overall survival is reported at 1 year', 'unitOfMeasure': 'percentage of patient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients without major deviation on study protocol and eligibility criteria who indicated at least one priority in the prioritization grid at the initiation of treatment'}, {'type': 'SECONDARY', 'title': 'Agreement Rate for Prioritization of Expectations Between Patients and Physicians', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elderly Patient (70 Years and Older)', 'description': 'Geriatric consultation, evaluation questionnaire: Geriatric consultation, evaluation questionnaire'}, {'id': 'OG001', 'title': 'Young Patient (18 Years - 69 Years)', 'description': 'Consultation, evaluation questionnaire: Consultation, evaluation questionnaire'}], 'classes': [{'title': 'Treatment efficacy', 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}, {'title': 'Life expectancy', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Autonomy', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Daily tasks', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Social activities', 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Burden of treatment', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Toxicity', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Economic burden', 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 initiation of treatment', 'description': 'For each expectation, the agreement rate is defined by the same prioritization or non-prioritization by the patient-physician pairs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients without major deviations from study protocol and eligibility criteria who indicated at least one priority in the prioritization grid at treatment initiation and whose physician also indicated at least one priority in the prioritization grid.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Elderly Patient (70 Years and Older)', 'description': 'Geriatric consultation, evaluation questionnaire: Geriatric consultation, evaluation questionnaire'}, {'id': 'FG001', 'title': 'Young Patient (18 Years - 69 Years)', 'description': 'Consultation, evaluation questionnaire: Consultation, evaluation questionnaire'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '246'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'Major Deviation From Protocol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Major Deviation on Eligibility Criteria', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '227'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment from January 2016 to January 2022 in 8 centers.', 'preAssignmentDetails': 'Elderly patients (≥ 70 years of age) were recruited by the investigating oncologists or geriatricians at organ-specific multidisciplinary consultation meetings (RCP) or during consultations.\n\nYounger patients were identified and recruited in the same way, mainly through RCP or specialized consultation by oncologists.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Elderly Patient (70 Years and Older)', 'description': 'Geriatric consultation, evaluation questionnaire: Geriatric consultation, evaluation questionnaire'}, {'id': 'BG001', 'title': 'Young Patient (18 Years - 69 Years)', 'description': 'Consultation, evaluation questionnaire: Consultation, evaluation questionnaire'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '79.2', 'groupId': 'BG000', 'lowerLimit': '75.4', 'upperLimit': '96.6'}, {'value': '61.3', 'groupId': 'BG001', 'lowerLimit': '54.2', 'upperLimit': '66.4'}, {'value': '75.9', 'groupId': 'BG002', 'lowerLimit': '67.7', 'upperLimit': '96.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Eligible population : Patients without major deviation on study protocol and eligibility criteria'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-17', 'size': 502159, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-10T03:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 346}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2016-06-14', 'resultsFirstSubmitDate': '2025-06-10', 'studyFirstSubmitQcDate': '2016-06-29', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-10', 'studyFirstPostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Priorities of Patients Receiving First Medical Treatment for Cancer at Treatment Initiation', 'timeFrame': 'Day 0 initiation of treatment', 'description': 'Prioritization among of the 4 items selected from a list of 8 expectations regarding the objectives of their treatment : treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden.\n\nFor each expectation, the number and rate of priorization are reported.'}, {'measure': 'Priorities of Patients Receiving First Medical Treatment for Cancer 3 Months After Initiation of Treatment', 'timeFrame': '3 months after initiation of treatment', 'description': 'Prioritization among of the 4 items selected from a list of 8 expectations regarding the objectives of their treatment : treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden.\n\nFor each expectation, the number and rate of priorization are reported.'}], 'secondaryOutcomes': [{'measure': 'Expectations of Patients at Initiation of Treatment', 'timeFrame': 'Day 0 initiation of treatment', 'description': 'Patients had to rate on a 5-point Likert scale (not at all / a little / moderately / quite / a lot) their expectations for treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden'}, {'measure': 'Expectations of Patients 3 Months After Initiation of Treatment', 'timeFrame': '3 months after initiation of treatment', 'description': 'Patients had to rate on a 5-point Likert scale (not at all / a little / moderately / quite / a lot) their expectations for treatment efficacy, life expectancy, autonomy, daily tasks, social activities, burden of treatment, toxicity and economic burden'}, {'measure': 'Stability of Patients in Their Priorities at 3 Months', 'timeFrame': '3 months after initiation of treatment', 'description': 'For each expectation, stability is defined as the prioritization of the expectation at treatment initiation and 3 months after treatment initiation'}, {'measure': '1-year Overall Survival', 'timeFrame': 'From inclusion to the end of study', 'description': 'Overall survival is defined as the time between the date of inclusion and the date of death, whatever the cause.\n\nThe rate of overall survival is reported at 1 year'}, {'measure': 'Agreement Rate for Prioritization of Expectations Between Patients and Physicians', 'timeFrame': 'Day 0 initiation of treatment', 'description': 'For each expectation, the agreement rate is defined by the same prioritization or non-prioritization by the patient-physician pairs.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Colorectal Cancer', 'Kidney Cancer', 'Lung Cancer', 'Prostate Cancer', 'Sarcoma', 'Ovarian Cancer', 'Lymphoma']}, 'descriptionModule': {'briefSummary': 'The main objective of study is to describe the priorities of elderly patients (70 years and over) undergoing a first medical treatment for cancer, at initiation of treatment and after 3 months of treatment. The main criterion is a prioritization of 4 items per patient from a list of 8 expectations regarding the objectives of their treatment: treatment efficacy, life expectancy, autonomy, daily activities, social activities, heaviness of treatment, toxicity, economics.', 'detailedDescription': "For the primary endpoint assessment, this self-administered patient questionnaire will used an opinion scale (Not at all, A little, Moderately, Enough, Many) to explore the eight domains. Next to the completion of the expectations questionnaire, patients will have to order 4 of the different 8 items that they prioritized in regard of the first line treatment that has just been prescribed by their physician.\n\nSecondary endpoint will focus on those 8 proposed expectations of patients at different periods of time since treatment initiation. Patients' priorities will be compared to physician's priorities (using the same prioritization grid) before medical treatment and after 3 months of treatment and to younger patients' priorities (18-69 years). Associations between elderly patients' characteristics (social, medical…) and their priorities will be search."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '400 patients aged 70 years old or more and 100 patient between 18 and 69 years old.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female:\n\n 1. Age ≥ 70 years\n 2. Aged 18-69 years (case population)\n2. ECOG / performance status 0-3 (WHO).\n3. First line of medical oncology treatment (chemotherapy, targeted therapy, hormone therapy, combination):\n\n 1. Neo-adjuvant setting,\n 2. Adjuvant setting: previous neo-adjuvant treatment is allowed,\n 3. Metastatic setting: previous neo-adjuvant and/or adjuvant treatment are allowed,\n4. Solid tumors (breast, colorectal, kidney, lung, prostate, sarcoma, and ovarian) and lymphoma (indolent and aggressive).\n5. Life expectancy of more than 3 months.\n6. Patients potentially compliant with the rules of the follow-up study.\n7. Patients affiliated to a social security scheme.\n8. Patients who received clear information from the investigator on the study and had not refused to participate.\n\nExclusion Criteria:\n\n1. Exclusive surgery treatment.\n2. Exclusive radiotherapy treatment or in combination with oncological medical treatment (concomitant radio-chemotherapy or radio-hormonotherapy).\n3. Previous first line of oncological medical treatment in the same indication as the one concerned by the inclusion:\n\n 1. Neo-adjuvant setting: previous line(s) of neo-adjuvant medical treatment,\n 2. Adjuvant setting: previous line(s) of adjuvant medical treatment,\n 3. Metastatic setting: previous line(s) of metastatic medical treatment,\n4. Supportive care without specific medical treatment\n5. Previous or ongoing cancer under treatment at the time of inclusion.\n6. Patient already included in this study\n7. Patient who for psychological, psychiatric, social, family or geographical reasons could not be regularly monitored according to the criteria of the study; patient private of liberty or under guardianship.'}, 'identificationModule': {'nctId': 'NCT02821793', 'acronym': 'PRIORITY', 'briefTitle': 'Expectations and Priorities of Elderly Patients for a First Medical Treatment for Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Institut Bergonié'}, 'officialTitle': 'Expectations and Priorities of Elderly Patients for a First Medical Treatment for Cancer : PRIORITY Study', 'orgStudyIdInfo': {'id': 'IB 2015-06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elderly patient (70 years and older)', 'interventionNames': ['Other: Geriatric consultation, evaluation questionnaire']}, {'label': 'Young patient (18 years - 69 years)', 'interventionNames': ['Other: Consultation, evaluation questionnaire']}], 'interventions': [{'name': 'Consultation, evaluation questionnaire', 'type': 'OTHER', 'description': 'Consultation, evaluation questionnaire', 'armGroupLabels': ['Young patient (18 years - 69 years)']}, {'name': 'Geriatric consultation, evaluation questionnaire', 'type': 'OTHER', 'description': 'Geriatric consultation, evaluation questionnaire', 'armGroupLabels': ['Elderly patient (70 years and older)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Bergonié', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation Université de Bordeaux', 'class': 'UNKNOWN'}, {'name': 'AG2R La Mondiale', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}