Authors
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Eastern Health -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2014
INTERVENTION: Integrated oncogeriatric care Integrated oncogeriatric care consists of comprehensive geriatric assessment and management, integrated with standard oncology care. In addition to seeing their oncologists, participants receiving integrated oncogeriatric care will have a comprehensive assessment and management by a consultant physician in geriatric medicine within 3 weeks from randomisation, followed by reviews at approximately 12 weeks and 24 weeks from randomisation. After 24 weeks from randomisation, participants in the intervention arm may continue to receive integrated oncogeriatric care but will not be required to complete further study assessments. CONDITION: Cancer in older adults PRIMARY OUTCOME: The Trial Outcome Index, which consists of the linear transformation from 0 to 100 of the unweighted summated scores of the physical functioning, role functioning and social functioning scales of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ‐C30 questionnaire, and the mobility scale of the EORTC QLQ‐ELD14 questionnaire. SECONDARY OUTCOME: Anxiety, as assessed using the Generalized Anxiety Disorder 7‐item (GAD‐7) instrument Depression, as assessed using the Patient Health Questionnaire 9‐item (PHQ‐9) instrument Function, as assessed using the Katz Activities of Daily Living (ADL) scale and the Older American Resources and Services (OARS) Independent Activities of Daily Living scale Health utilities, as assessed using the EQ‐5D‐5L Healthcare cost, based on review of partcipants' medical records and Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) data. ; ; Costs will be calculated for the use of healthcare resources such as Medicare‐reimbursed costs, medications (including chemotherapy), emergency department visits, hospital stays and the use of other healthcare services (including allied health, rehabilitation, aged care and palliative care). Healthcare utilisation, as assessed by number of emergency department visits, number of hospital admissions, number of medical consultations and type of PBS‐listed medications, based on review of the participants' medical records. Institutionalisation, as assessed by the place of residence and by the level of care, based on review of the participants' medical records. Nutrition, as assessed by the self‐Mini Nutritional Assessment (self‐MNA) Overall survival Performance status, as assessed using the self‐rated Eastern Cooperative Oncology Group (ECOG) Performance Status scale and the self‐rated Karnofsky Performance Status scale Proportion of participants with dose discontinuation, based on review of participants' medical records. Proportion of participants with dose reduction >10% from previous dose, based on review of participants' medical records. Proportion of participants with treatment delays of more than 14 days, based on review of participants' medical records. Quality of life, as assessed using the EORTC QLQ‐C30 v3.0, EORTC QLQ‐ELD14 and EQ‐5D‐5L Relative Dose Intensity (RDI), calculated by the ratio of delivered dose intensity of chemotherapy to standard dose for the time period, based on review of participants' medical records. INCLUSION CRITERIA: 1. Aged 70 years or older 2. Pathologically confirmed solid organ cancer or diffuse large B‐cell lymphoma 3. Planned for cytotoxic chemotherapy, targeted therapy or immunotherapy 4. Able to effectively understand the language of the quality of life questionnaires in one of the validated languages for the questionnaires 5. Able to give written informed consent before randomisation according to local, national and international regulations
Epistemonikos ID: d03d756d32ce4e0113515f79ef813eb256d093c8
First added on: Aug 23, 2024