None listed
Conditions
Brief summary
The primary purpose of this study is to evaluate whether formal assessment tools for the elderly can predict chemotherapy toxicity in older adults with cancer, better than an oncologist's assessment as part of standard care. Who is it for? You may be eligible to participate in this study if you are aged 65 years or older, and have been diagnosed with any type of cancer for which you are due to begin chemotherapy. Study details All participants will complete a health questionnaire (known as a "geriatric assessment), which includes calculation of the CARG toxicity score. The geriatric assessment covers physical and mental wellbeing, any additional illnesses, history of falls, cognition, nutrition, and a timed walk test. The assessment session takes place over 30 minutes, once, prior to beginning chemotherapy. Researchers will then assess the level of chemotherapy toxicity throughout the planned chemotherapy, and will look at survival at one year. It is hoped that the findings of this trial will provide information on whether the CARG toxicity score can aid oncologists with the prediction of chemotherapy toxicity in elderly patients.
Interventions
Intervention: Geriatric assessment and calculation of CARG Toxicity Score. This involves a face-to-face health questionnaire with the participant performed by a study researcher and takes no longer than 30 minutes. Health domains covered as part of the geriatric assessment include functional status, comorbidity, history of falls, cognition, nutrition, psychosocial health and a timed walk test. The geriatric assessment is performed in the outpatient clinic area on one occasion prior to the partic
Intervention: Geriatric assessment and calculation of CARG Toxicity Score. This involves a face-to-face health questionnaire with the participant performed by a study researcher and takes no longer than 30 minutes. Health domains covered as part of the geriatric assessment include functional status, comorbidity, history of falls, cognition, nutrition, psychosocial health and a timed walk test. The geriatric assessment is performed in the outpatient clinic area on one occasion prior to the participant commencing treatment with chemotherapy. The treating oncologist is asked to nominate for each patient their estimate of the likelihood of severe chemotherapy toxicity over the course of treatment, and make an assessment of the patient's clinical frailty status and performance status. For Part 1 of the study, the treating oncologist is not made aware of the results of the geriatric assessment and CARG Toxicity Score, but results are recorded by study researchers. Participants are followed throughout their chemotherapy course to observe for severe chemotherapy-related toxicity and treatment deliverability (unplanned hospital admissions, dose modifications). After target accrual for Part 1 of the study, transition will be made to Part 2, where results of the geriatric assessment and CARG Toxicity Score will be presented to the treating oncologist prior to the patient commencing chemotherapy. The treating oncologist will complete a questionnaire, taking no more than 10 minutes, addressing how useful they found the provided information from the geriatric assessment, if it provided them with new information above their usual clinical assessment, and if they would modify their proposed treatment plan or employ any additional interventions based on the results. The treating oncologist may amend their planned care plan for the patient at their own discretion.
Sponsors
Dr Erin Moth
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age 65 years or older Clinical, radiological or histopathological diagnosis of malignancy, any stage Seen by a medical oncologist in the outpatient setting Due to start a new line of systemic cytotoxic chemotherapy Sufficient English proficiency to complete study assessments
Exclusion criteria
Concurrent radiotherapy Use of PD-1 treatment alone or in combination with chemotherapy Use of single agent targeted therapies
Outcome results
None listed