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

NCT04193657 | Completed

• 1 other identifier: 19-5766
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 2

Brief Summary

1. 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. 2.The study aims to determine:
3. 3.if symptom monitoring (daily) is feasible using telephone or electronic means of communications in the elderly or frail patient with mCRPC
4. 4.The time course/pattern of symptoms important to quality of life for patients undergoing chemotherapy, abi/enza, or Radium 223
5. 5.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

Conditions

Metastatic Prostate Cancer

Keywords

Metastatic Prostate Cancer; Older men; Supportive care; Frailty

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Participants symptom experience by Qualitative interview

  30 minutes

• Study Completion Questionnaire to measure participant burden and satisfaction

  5 minutes

Study Arms (4)

Chemotherapy

30 participants starting chemotherapy

Other: Daily and weekly triggered symptom monitoring

Abiraterone

20 participants starting Abiraterone

Other: Daily and weekly triggered symptom monitoring

Enzalutamide

20 participants starting Enzalutamide

Other: Daily and weekly triggered symptom monitoring

Radium-223

20 participants starting Radium-223

Other: Daily and weekly triggered symptom monitoring

Interventions

Daily and weekly triggered symptom monitoring OTHER

Participants are invited to complete a daily questionnaire, a weekly questionnaire, and to track daily activity with an electronic activity tracker.

Also known as: Daily Step count

Abiraterone; Chemotherapy; Enzalutamide; Radium-223

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: Prostate cancer occurs in males only.
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Prostate Cancer Canada: collaborator

Study Sites (2)

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Frailty

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shabbir Alibhai, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 10, 2019
• Study Start: October 25, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 31, 2021
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

CA (2)