An observational study in Metastatic Prostate Cancer, sponsored by University Health Network, Toronto. Completed at 2 sites in Canada. Open to male participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by University Health Network, Toronto · Observational
The study aims to determine:
Study Aim:
The previous multi-centre observational study (TOPCOP), funded by Prostate Cancer Canada, demonstrated important declines in multiple areas of quality of life, and fatigue and functional decline which were common issues that often limited further treatment. Emerging data from other settings demonstrate that (a) close monitoring of symptoms may reduce treatment toxicity and improve survival; (b) improving physical activity and targeting pain and sleep may improve fatigue and function. Whether these are feasible in the setting of older or frail men with mCRPC is unclear. Incorporating what the investigators have learned from TOPCOP and emerging supportive oncology literature, our main aim is to examine the emergence of key symptoms (fatigue, pain, insomnia) and explore whether reductions in daily physical activity are early indicators of toxicity over one treatment cycle (3-4 weeks) and therefore targetable in a subsequent intervention study.
Study Design:
This is a prospective multicentre observational study. The investigators will enroll English-speaking men with mCRPC who are either age 75 or older or age 60-74 and frail using (a) chemotherapy; (b) abiraterone or enzalutamide; (c) Radium.
Daily telephone-based brief symptom screening will be done with the Edmonton Symptom Assessment Scale (ESAS). Daily monitoring of physical activity (step counts) will be done with commercial smartphone apps or a Fitbit device. Moderate or higher symptoms (>3/10) on ESAS or a decrease in daily step count of 15% or more triggers more detailed telephone-based toxicity assessment and measures of pain, sleep, and fatigue as appropriate. The study duration is 3 weeks (1 cycle of chemotherapy) or 4 weeks (abiraterone/enzalutamide/radium). Qualitative interviews will be done to explore challenges with treatment tolerability and adherence.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 91 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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30 participants starting chemotherapy
Other: Daily and weekly triggered symptom monitoring
20 participants starting Abiraterone
Other: Daily and weekly triggered symptom monitoring
20 participants starting Enzalutamide
Other: Daily and weekly triggered symptom monitoring
20 participants starting Radium-223
Other: Daily and weekly triggered symptom monitoring
Participants are invited to complete a daily questionnaire, a weekly questionnaire, and to track daily activity with an electronic activity tracker.
Also known as: Daily Step count
Daily monitoring with Edmonton Symptom Assessment Scale (ESAS)
Number of participants with treatment-related adverse events as measured by ESAS.Moderate or higher symptoms (\>3/10) on ESAS triggers more detailed telephone-based toxicity assessment
Time frame: 3-4 weeks
Using a personal physical activity tracker step counts are monitored daily.
Number of participants with a decrease in daily step count of 15% or more that triggers more detailed telephone-based assessment.
Time frame: 3-4 weeks
Brief Pain Inventory-Short Form (BPI-SF) to measure pain severity
Number of participants with ESAS pain score greater than 3 that triggered BPI-SF. than 3
Time frame: 3-4 weeks
Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) to measure fatigue
Number of participants with ESAS fatigue score greater than 3 that triggered MFSI-SF.
Time frame: 3-4 weeks
Insomnia Severity Index (ISI) to measure treatment related insomnia
Number of participants with ESAS insomnia score greater than 3 that triggered ISI
Time frame: 3-4 weeks
Patient Health Questionnaire 9-item (PHQ-9) to measure treatment related depression
Number of participants with ESAS depression score greater than 3 that triggered PHQ-9.
Time frame: 3-4 weeks
Generalized Anxiety Disorder 7-item (GAD) to measure treatment related anxiety
Number of participants with ESAS anxiety score greater than 3 that triggered GAD
Time frame: 3-4 weeks
Participants symptom experience by Qualitative interview
Participants in each treatment arm will be invited to participate in semi-structured one-time qualitative interviews after one cycle of treatment. The interview will focus on the symptom experience, impact on daily life, strategies used to manage symptoms, and suggestions for external support.
Time frame: 30 minutes
Study Completion Questionnaire to measure participant burden and satisfaction
Number of participants that experienced burden or satisfaction by the study.
Time frame: 5 minutes
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto