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Supportive Care Intervention for Prostate Cancer (TOPCOP3 Trial)
N/A
Recruiting
Led By Shabbir Alibhai, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
TOPCOP3 Trial Summary
This trial aims to evaluate a complex medical intervention to improve treatment for older cancer patients. It will provide data to design a larger trial. Feasibility objectives & analytic plan are in place. Support from cancer advocacy and policy groups.
Who is the study for?
This trial is for men aged 70 or older with metastatic prostate cancer who are starting ARAT treatment. They must be able to give written consent and have a working phone. It's not for those who can't speak English, have a life expectancy under 3 months, or major neuropsychiatric issues like severe depression or dementia.Check my eligibility
What is being tested?
The TOPCOP3 study tests the effectiveness of geriatric assessment and management (GA+M), remote symptom monitoring (RSM), both interventions together (GA+RSM), or neither. This pilot RCT aims to gather data on these supportive care methods to plan larger trials.See study design
What are the potential side effects?
Since this trial focuses on supportive care rather than direct medical treatments, side effects may include discomfort from assessments, potential stress from frequent monitoring, and possible privacy concerns with remote communication.
TOPCOP3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Health related quality of life in patients with metastatic prostate cancer
Number of participants with Grade 3-5 Toxicity
Secondary outcome measures
Anorexia
Depression
Fatigue
+6 moreOther outcome measures
Process evaluation: Acceptability
Process evaluation: Feasibility
TOPCOP3 Trial Design
4Treatment groups
Active Control
Group I: RSM InterventionActive Control1 Intervention
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.
Group II: GA+RSM interventionActive Control1 Intervention
GA+RSM Combination Participants will receive both strategies as detailed above, with a GA at baseline.
Group III: ControlActive Control1 Intervention
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.
Group IV: GA+M InterventionActive Control1 Intervention
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.
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,476 Previous Clinical Trials
485,012 Total Patients Enrolled
64 Trials studying Prostate Cancer
15,400 Patients Enrolled for Prostate Cancer
Shabbir Alibhai, MDPrincipal InvestigatorUHN - Princess Margaret Cancer Centre
5 Previous Clinical Trials
720 Total Patients Enrolled
1 Trials studying Prostate Cancer
159 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe depression or moderate to severe dementia.I am 70 years old or older.I am starting treatment for metastatic prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: RSM Intervention
- Group 2: GA+RSM intervention
- Group 3: Control
- Group 4: GA+M Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the end goal of this experiment?
"This scientific trial has a 6 month timeline and will be assessing three primary outcomes; Grade 3-5 Toxicity, Insomnia evaluated using the Insomina Severity Index (PRO), and Fatigue employing the Brief Fatigue Inventory. Additionally, it'll measure decline in Instrumental Activities of Daily Living with an OARS scale (PR)."
Answered by AI
Are researchers currently looking for participants in this experiment?
"According to clinicaltrials.gov, this particular trial is no longer actively enrolling patients since it was last updated on October 12th 2022. Notwithstanding, there are a plethora of other studies that need participants, totalling up to 1,258 in number at present."
Answered by AI
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