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

Metastatic Prostate Cancer Clinical Trial

— TOPCOP2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04193657
• Other study ID #: 19-5766
• Status: Completed
• Start date: October 25, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 31, 2021
• Est. primary completion date: December 30, 2021
• Gender: Male
• Age group: 60 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Odette Cancer Centre	Toronto	Ontario
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Prostate Cancer Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Study Completion Questionnaire to measure participant burden and satisfaction	Number of participants that experienced burden or satisfaction by the study.	5 minutes