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Completed

NCT Number: NCT04193657

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

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

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Key information

Conditions

Metastatic Prostate Cancer Frailty Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

60 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Odette Cancer Centre, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

-

Treatment and study plan

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.

Other names: Daily Step count

Primary outcomes

  1. Daily monitoring with Edmonton Symptom Assessment Scale (ESAS)

    Time frame: 3-4 weeks

    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

  2. Using a personal physical activity tracker step counts are monitored daily.

    Time frame: 3-4 weeks

    Number of participants with a decrease in daily step count of 15% or more that triggers more detailed telephone-based assessment.

  3. Brief Pain Inventory-Short Form (BPI-SF) to measure pain severity

    Time frame: 3-4 weeks

    Number of participants with ESAS pain score greater than 3 that triggered BPI-SF. than 3

  4. Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) to measure fatigue

    Time frame: 3-4 weeks

    Number of participants with ESAS fatigue score greater than 3 that triggered MFSI-SF.

  5. Insomnia Severity Index (ISI) to measure treatment related insomnia

    Time frame: 3-4 weeks

    Number of participants with ESAS insomnia score greater than 3 that triggered ISI

  6. Patient Health Questionnaire 9-item (PHQ-9) to measure treatment related depression

    Time frame: 3-4 weeks

    Number of participants with ESAS depression score greater than 3 that triggered PHQ-9.

  7. Generalized Anxiety Disorder 7-item (GAD) to measure treatment related anxiety

    Time frame: 3-4 weeks

    Number of participants with ESAS anxiety score greater than 3 that triggered GAD

Secondary outcomes

  1. Participants symptom experience by Qualitative interview

    Time frame: 30 minutes

    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.

  2. Study Completion Questionnaire to measure participant burden and satisfaction

    Time frame: 5 minutes

    Number of participants that experienced burden or satisfaction by the study.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Prostate Cancer Canada

Registry information

Acronym: TOPCOP2

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 10, 2019
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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