TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer (TOPCOP3)
Metastatic Prostate Cancer
About this trial
This is an interventional supportive care trial for Metastatic Prostate Cancer focused on measuring Geriatric assessment, ARAT, Supportive Care, Older men
Eligibility Criteria
Inclusion Criteria:
- Starting an ARAT for mPC (castration-sensitive or resistant)
- At least 70 years old
- Able to provide written informed consent
- Has a working telephone
Exclusion Criteria:
- Unable to speak English (as contact with the nurse interventionist is via phone, not all outcome measures are available in multiple languages)
- Major neuropsychiatric abnormalities (severe depression or moderate-severe dementia)
- Life expectancy <3 months as estimated by the oncologist
Sites / Locations
- University Health Network - Princess Margaret Cancer CentreRecruiting
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
No Intervention
GA+M Intervention
RSM Intervention
GA+RSM intervention
Control
GA+M intervention arm All participants in the GA+M intervention arm will undergo a standardized GA by a trained nurse and geriatrician. The GA will include 8 domains (comorbidity, medication review, function, falls risk, nutrition, social supports, cognition, and mood) similar to our 5C protocol. Based on any detected abnormalities or issues, a standardized set of strategies will be implemented (e.g. increased falls risk will lead to detailed assessment of balance and gait, consideration of gait aid, and referral to outpatient physiotherapy). This follows the standard approach to implementing GA similar to recent trials in geriatric oncology including 5C. Monthly telephone follow-up by the nurse and review with the geriatrician as needed will be done to ensure identified issues have been addressed.
RSM Intervention All participants in the RSM intervention arm will receive once-weekly symptom monitoring via email-based surveys using the 9-item Edmonton Symptom Assessment Scale within a secure customized REDCap interface. If patients prefer, weekly telephone calls will be done instead by a research assistant to elicit If there are moderate or severe symptoms (score of 4+ out of 10), an oncology nurse will obtain more detailed symptom information and provide evidence-based symptom-targeted recommendations using the pan-Canadian Oncology Symptom Triage and Remote Support (COSTaRS) Practice Guide. Symptom monitoring will continue for 6 months or discontinuation of treatment.
GA+RSM Combination Participants will receive both strategies as detailed above, with a GA at baseline.
Control Usual care consists of brief verbal education and a drug pamphlet to all patients when starting an ARAT. There is no GA+M and no RSM at either site. Patients have access to a 24x7 oncology nursing line or a 24/7 pharmacy line.