A Web-based Peer Navigation Program for Men With Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Behavioral: Peer navigationOther: Active wait list control
- Registration Number
- NCT05041504
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
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.
- Detailed Description
Background: Prostate cancer (PC) is a highly prevalent condition affecting 1 in 9 Canadian men. While the 5-year survival rate for PC is 93%, treatment-related side effects, such as sexual dysfunction and urinary incontinence, can significantly affect quality of life. Men with PC lack access to relevant information and emotional support, and report gaps in supportive care when dealing with these difficult issues. Previous research has shown that cancer patient navigation improves the timeliness of care and support, and reduces healthcare costs. Engaging volunteer cancer survivors as navigators is less costly, provides peer support, and benefits the navigator by improving their psychosocial health. The investigators developed True North Peer Navigation - an evidence-based peer navigation program for men with PC and a competency-based peer navigator training course. Men are matched online with a trained peer navigator who assesses needs and barriers to care, provides practical, informational, and emotional support, and empowers them to take a proactive role in their health. A pilot study showed True North Peer Navigation is highly acceptable to patients and peer navigators, and associated with improvements in quality of life, social support and patient activation to manage health.
Aim: This project aims to advance knowledge on the effectiveness and implementation of a web-based peer navigation program for men after treatment for PC.
Specific Objectives:
1. To determine the effect of True North Peer Navigation on patient outcomes in men with PC; and
2. To evaluate the delivery of True North Peer Navigation in terms of fidelity, cost, and the experiences of patients and peer navigators, and to identify barriers and facilitators to its implementation in oncology settings.
Methods: Guided by the SPOR Patient Engagement Framework, the investigators will conduct a type-1 hybrid effectiveness-implementation study at cancer centres in Ontario, British Columbia and Nova Scotia. For objective 1, the investigators will conduct a pragmatic randomized controlled trial to evaluate the impact of True North Peer Navigation compared to an active wait list control on patient activation (primary) and needs, quality of life, anxiety, depression, fear of recurrence, social support, and access to services (secondary). Two hundred and forty patients (n=120 per arm) with PC will be recruited after treatment. Outcomes will be assessed at baseline (T0), 3-months (T1) and 6-months (T2). Objective 2 will involve a mixed-method process evaluation to investigate implementation fidelity, patient and navigator experiences, and cost-effectiveness of True North Peer Navigation, and to assess implementation barriers and facilitators with stakeholders informed by the Consolidated Framework for Implementation Research and the Theoretical Domains Framework.
Significance: True North Peer Navigation is an innovative solution to an important service gap in the lives of men with PC. This study has the potential to generate important evidence and strategies to support the implementation of peer navigation programs to improve the health outcomes of men with PC in Canada.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 184
- Has been diagnosed with local, locally advanced or stable metastatic PC.
- Has recently completed treatment within 3 months
- Has an email address OR is willing to create one.
- Can read and speak English.
- Has been diagnosed with advanced metastatic disease.
- Is receiving palliative care.
- Is not willing to be randomized.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Peer navigation Participants assigned to the intervention arm will receive the True North Peer Navigation intervention. Active Waitlist Control Active wait list control Participants assigned to the control arm will receive usual care and access to an online health resource library. After completion of the study, they will receive the True North Peer Navigation intervention.
- Primary Outcome Measures
Name Time Method Change in Patient Activation at 3 months 0, 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.
- Secondary Outcome Measures
Name Time Method Change in Anxiety 0, 3, 6 months 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.
Change in Patient Activation at 6 months 0, 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.
Change in Fear of Cancer Recurrence 0, 3, 6 months 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.
Change in Prostate Cancer Quality of Life 0, 3, 6 months 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.
Change in Depression 0, 3, 6 months 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.
Change in Social Support 0, 3, 6 months 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.
Change in Supportive Care Needs 0, 3, 6 months 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.
Change in Health-Related Quality of Life 0, 3, 6 months 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.
Trial Locations
- Locations (5)
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
BC Cancer - Vancouver
🇨🇦Vancouver, British Columbia, Canada
Cape Breton Regional Hospital
🇨🇦Sydney, Nova Scotia, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada