Clinical trial NCT04193657: Toward a Comprehensive Supportive Care Intervention for Older or Frail Men With mCRPC
Official title: Toward a Comprehensive Supportive Care Intervention for Older or Frail Men With mCRPC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Prostate Cancer
Keywords: Metastatic Prostate Cancer
Older men
Supportive care
Frailty
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Prostate Cancer Canada
First posted: 2019-12-10
Enrollment: 91
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Daily monitoring with Edmonton Symptom Assessment Scale (ESAS)
timeFrame: 3-4 weeks
measure: Using a personal physical activity tracker step counts are monitored daily.
timeFrame: 3-4 weeks
measure: Brief Pain Inventory-Short Form (BPI-SF) to measure pain severity
timeFrame: 3-4 weeks
measure: Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) to measure fatigue
timeFrame: 3-4 weeks
measure: Insomnia Severity Index (ISI) to measure treatment related insomnia
timeFrame: 3-4 weeks
measure: Patient Health Questionnaire 9-item (PHQ-9) to measure treatment related depression
timeFrame: 3-4 weeks
measure: Generalized Anxiety Disorder 7-item (GAD) to measure treatment related anxiety
timeFrame: 3-4 weeks
Secondary outcomes:
measure: Participants symptom experience by Qualitative interview
timeFrame: 30 minutes
measure: Study Completion Questionnaire to measure participant burden and satisfaction
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Shabbir Alibhai, MD
role: PRINCIPAL_INVESTIGATOR
References: