Prostate Cancer Clinical Trial
Official title:
A Web-based Peer Navigation Program for Men With Prostate Cancer: A Hybrid Effectiveness-Implementation Trial
Verified date | April 2024 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
One in nine Canadian men will be diagnosed with prostate cancer (PC) in their lifetime. Although all treatment options can be effective in controlling the disease, treatment side effects such as problems with erections and controlling the bladder can significantly affect men's quality of life. Many men with PC say they do not get relevant information and emotional support, and experience gaps in care when dealing with these difficult issues. Previous studies have shown that cancer patient navigation improves access to care and support, and reduces healthcare costs. The investigators developed True North Peer Navigation - a peer navigation program for men with PC and a peer navigator training course. Men are matched online with a trained peer navigator who provides practical information and emotional support through the cancer journey. A pilot evaluation showed that it is highly acceptable to patients and peer navigators, and improves patient quality of life, social support and ability to manage their health. In this study, the investigators will conduct a randomized controlled trial of the True North Peer Navigation program in cancer centres in Ontario, British Columbia and Nova Scotia. Patients will be randomly assigned to receive True North Peer Navigation or an active wait list control consisting of usual care with access to information on the True North Peer Navigation website. The investigators will evaluate the effect of the True North Peer Navigation program on patient outcomes such as their ability to take a more active role in their health, quality of life, social support and use of health care services. In addition, the investigators will evaluate how True North Peer Navigation was implemented, the experiences patients and peer navigators, the factors that make it easier or harder for people to deliver the program to patients in different settings, as well as the cost of delivering the program, which will help us learn how to spread the program across the country.
Status | Active, not recruiting |
Enrollment | 184 |
Est. completion date | July 2024 |
Est. primary completion date | March 18, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Has been diagnosed with local, locally advanced or stable metastatic PC. 2. Has recently completed treatment within 3 months 3. Has an email address OR is willing to create one. 4. Can read and speak English. Exclusion Criteria: 1. Has been diagnosed with advanced metastatic disease. 2. Is receiving palliative care. 3. Is not willing to be randomized. |
Country | Name | City | State |
---|---|---|---|
Canada | Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia |
Canada | Cape Breton Regional Hospital | Sydney | Nova Scotia |
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
Canada | BC Cancer - Vancouver | Vancouver | British Columbia |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Canadian Cancer Society (CCS), Canadian Partnership Against Cancer, Dalhousie University, Movember Foundation, Prostate Cancer Group - Burnaby, Prostate Cancer Support - Toronto, University of British Columbia, University of Toronto, Walnut Foundation |
Canada,
Bender JL, Flora PK, Milosevic E, Soheilipour S, Maharaj N, Dirlea M, Parvin L, Matthew A, Kazanjian A. Training prostate cancer survivors and caregivers to be peer navigators: a blended online/in-person competency-based training program. Support Care Cancer. 2021 Mar;29(3):1235-1244. doi: 10.1007/s00520-020-05586-8. Epub 2020 Jul 2. — View Citation
Flora PK, Bender JL, Miller AS, Parvin L, Soheilipour S, Maharaj N, Milosevic E, Matthew A, Kazanjian A. A core competency framework for prostate cancer peer navigation. Support Care Cancer. 2020 Jun;28(6):2605-2614. doi: 10.1007/s00520-019-05059-7. Epub 2019 Oct 15. — View Citation
Maharaj N, Soheilipour S, Bender JL, Kazanjian A. Understanding Prostate Cancer Patients and Caregivers Support Needs: How Do They Manage Living with Cancer? Illness, Crisis & Loss. 2018; April 5:51-73.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quality-adjusted life year | An estimation of the combined health utility values derived from responses from the European Quality of Life, 5 Dimensions, 5 Levels (EQ-5D-5L) and length of life experienced by patient, between measurement time points. | 0,3,6 months | |
Other | Total healthcare costs | The total cost of publicly funded healthcare utilization (outside of delivery of the intervention) by patient while enrolled in the study. Number of times patient accessed publicly funded healthcare resources while enrolled in the study will be estimated based on the data gathered from the Health System Service Utilization Inventory (HSSUI). Resource use volumes will be used to micro-cost resource use costs such as physician care, allied health professional care, hospital care and pharmaceuticals. | 3,6 months | |
Other | Intervention cost | Incremental cost of the intervention (i.e., delivery of the peer navigation program not related to volunteer time, such as administrative costs, training costs, and overhead costs) will be estimated per patient. | 3 years | |
Primary | Change in Patient Activation at 3 months | The primary outcome will be change in Patient Activation from baseline to 3 months. Patient Activation will be measured using the Patient Activation Measure (PAM). Higher scores represent a better outcome. | 0, 3 months | |
Secondary | Change in Patient Activation at 6 months | Change in Patient Activation from baseline to 6 months will be assessed.Patient Activation will be measured using the Patient Activation Measure (PAM). Higher scores represent a better outcome. | 0, 6 months | |
Secondary | Change in Supportive Care Needs | Change in Supportive Care Needs from baseline will be assessed at 3 months and 6 months separately. Supportive Care Needs will be measured with the 34-item Supportive Care Needs Survey-Short Form (SCNS-SF) with a 7-item prostate cancer add-on module. Higher scores represent a worse outcome. | 0, 3, 6 months | |
Secondary | Change in Health-Related Quality of Life | Change in health-related quality of life from baseline will be assessed at 3 months and 6 months separately. Health-related quality of life will be measured with the European Quality of Life, 5 Dimensions, 5 Levels (EQ-5D-5L) overall utility score. Higher scores represent a worse outcome. | 0, 3, 6 months | |
Secondary | Change in Prostate Cancer Quality of Life | Change in Prostate Cancer Specific Quality of Life from baseline will be measured t 3 months and 6 months separately. Prostate Cancer Specific Quality of Life will be measured using the overall Patient-Oriented Prostate Utility Scale (PORPUS) score. Higher scores represent a worse outcome. | 0, 3, 6 months | |
Secondary | Change in Anxiety | Change in Anxiety from baseline will be assessed at 3 months and 6 months separately. Anxiety will be measured using the Generalized Anxiety Disorder scale (GAD-7). Higher scores represent a worse outcome. | 0, 3, 6 months | |
Secondary | Change in Depression | Change in Depression from baseline will be assessed at 3 months and 6 months separately. Depression will be measured using the depression module of the Patient Health Questionnaire (PHQ-9). Higher scores represent a worse outcome. | 0, 3, 6 months | |
Secondary | Change in Social Support | Change in Social Support from baseline will be measured at 3 months and 6 months separately. Social Support will be measured using the Enriched Social Support Scale, a multidimensional measure of perceived social support (ESSI). Higher scores represent a worse outcome. | 0, 3, 6 months | |
Secondary | Change in Fear of Cancer Recurrence | Change in Fear of Cancer Recurrence from baseline will be assessed at 3 months and 6 months separately. Fear of Cancer Recurrence will be measured using the Fear of Cancer Recurrence Inventory -Short Form Scale (FCRI-SF). Higher scores represent a worse outcome. | 0, 3, 6 months |
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