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

University Health Network, Toronto

Status: Completed

Conditions: Metastatic Prostate Cancer

Treatments: Other: Daily and weekly triggered symptom monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT04193657

19-5766

Details and patient eligibility

About

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

Full 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.

Enrollment: 91 patients

Sex: Male

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

91 participants in 4 patient groups

Chemotherapy

Description:

30 participants starting chemotherapy

Treatment:

Other: Daily and weekly triggered symptom monitoring

Abiraterone

Description:

20 participants starting Abiraterone

Treatment:

Other: Daily and weekly triggered symptom monitoring

Enzalutamide

Description:

20 participants starting Enzalutamide

Treatment:

Other: Daily and weekly triggered symptom monitoring

Radium-223

Description:

20 participants starting Radium-223

Treatment:

Other: Daily and weekly triggered symptom monitoring