Toward a Comprehensive Supportive Care Intervention for Older or Frail Men With mCRPC (TOPCOP2)

1. Multicentre pilot study (n=90) which aims to study a prevalent population of elderly or frail patients with mCRPC whom are often excluded from clinical trial participation. (Data is sorely needed in this population)

2. The study aims to determine:

   1. if symptom monitoring (daily) is feasible using telephone or electronic means of communications in the elderly or frail patient with mCRPC
   2. The time course/pattern of symptoms important to quality of life for patients undergoing chemotherapy, abi/enza, or Radium 223
   3. If changes in physical activity (quantified by fitbit) predict for changes to ESAS in men undergoing treatment d) Qualitatively assess the supportive care needs of older/frail men with mCRPC

Study Overview

• Status: Completed
• Conditions: Metastatic Prostate Cancer
• Intervention / Treatment: Other: Daily and weekly triggered symptom monitoring

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
    • Toronto, Ontario, Canada, M4N 3M5
      • Odette Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

1. Unable to speak English fluently.
2. Severe neuropsychiatric abnormalities.
3. Limited life expectancy (<3 months) as estimated by the primary oncologist or seeing palliative care.

Description

Inclusion Criteria:

1. Starting either chemotherapy, Radium-223, Abiraterone or Enzalutamide or starting chemo > one year post CHAARTED
2. At least 65 years old
3. Able to provide written informed consent
4. Diagnosed with metastatic castrate resistant prostate cancer
5. Total Testosterone level 1.7nmol/L
6. Has a working smartphone OR is willing to use a study provided smartphone

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chemotherapy; 30 participants starting chemotherapy	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.; Other Names: Daily Step count
Abiraterone; 20 participants starting Abiraterone	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.; Other Names: Daily Step count
Enzalutamide; 20 participants starting Enzalutamide	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.; Other Names: Daily Step count
Radium-223; 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.; Other Names: Daily Step count

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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.	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	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.	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	3-4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 minutes
Study Completion Questionnaire to measure participant burden and satisfaction	Number of participants that experienced burden or satisfaction by the study.	5 minutes

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Prostate Cancer Canada

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 25, 2019
• Primary Completion (ACTUAL): December 30, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (ACTUAL): December 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Frailty; Metastatic Prostate Cancer; Supportive care; Older men
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 19-5766

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No