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

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ClinicalTrials.gov Identifier: NCT04193657
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : December 10, 2019
Sponsor:
Collaborator:
Prostate Cancer Canada
Information provided by (Responsible Party):
University Health Network, Toronto

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

Condition or disease Intervention/treatment
Metastatic Prostate Cancer Other: Daily and weekly triggered symptom monitoring

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.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Toward a Comprehensive Supportive Care Intervention for Older or Frail Men With mCRPC
Actual Study Start Date : October 25, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Chemotherapy
30 participants starting chemotherapy
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.
Other Name: Daily Step count

Abiraterone
20 participants starting Abiraterone
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.
Other Name: Daily Step count

Enzalutamide
20 participants starting Enzalutamide
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.
Other Name: Daily Step count

Radium-223
20 participants starting Radium-223
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.
Other Name: Daily Step count




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate cancer occurs in males only.
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.
Criteria

Inclusion Criteria:

  1. Starting either chemotherapy, Radium-223, Abiraterone or Enzalutamide or starting chemo > one year post CHAARTED
  2. At least 75 years old, OR 60-74 and frail (as defined by a VES-13 score of >=3)
  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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193657


Contacts
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Contact: Shabbir Alibhai, MD 416-340-5125 shabbir.alibhai@uhn.ca
Contact: Henriette A Breunis 416-946-4501 ext 3926 hbreunis@uhnresearch.ca

Locations
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Canada, Ontario
Odette Cancer Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Urban Emmenegger, MD    416-480-4928    urban.emmenegger@sunnybrook.ca   
Principal Investigator: Urban Emmenegger, MD         
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Henriette Breunis    +1-416-946-4501 ext 3926    hbreunis@uhnresearch.ca   
Principal Investigator: Shabbir Alibhai, MD         
Sub-Investigator: Aaron Hansen, MD         
Sub-Investigator: Antonio Finelli, MD         
Sub-Investigator: Padraig Warde, MD         
Sub-Investigator: George Tomlinson, Dr         
Sub-Investigator: Monika Krzyzanowska, MD         
Sub-Investigator: Andrew Matthew, Dr         
Sub-Investigator: Hance Clarke, MD         
Sub-Investigator: Daniel Santa Mina, Dr         
Sub-Investigator: Martine Puts, Dr         
Sub-Investigator: Enrique Soto-Perez-de-Celis, MD         
Sponsors and Collaborators
University Health Network, Toronto
Prostate Cancer Canada
Investigators
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Principal Investigator: Shabbir Alibhai, MD University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04193657    
Other Study ID Numbers: 19-5766
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Metastatic Prostate Cancer
Older men
Supportive care
Frailty
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases