A Web-based Peer Navigation Program for Men With Prostate Cancer

Study Overview
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Brief Summary
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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
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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: To determine the effect of True North Peer Navigation on patient outcomes in men with PC; and 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.

Official Title
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A Web-based Peer Navigation Program for Men With Prostate Cancer: A Hybrid Effectiveness-Implementation Trial

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Peer navigation
* Other: Active wait list control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Has been diagnosed with advanced metastatic disease. Is receiving palliative care. Is not willing to be randomized.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a 2-arm pragmatic randomized controlled trial with an active wait-list control, and an embedded process evaluation. Participants in the intervention group will receive the True North Peer Navigation intervention. Participants in the active control group will receive access to an online health resource library and will be offered the True North Peer Navigation intervention after study completion.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants assigned to the intervention arm will receive the True North Peer Navigation intervention. | Behavioral: Peer navigation<br>* Participants in the intervention group will receive ongoing support from a trained peer navigator for 3 months after completing treatment for prostate cancer via the True North Peer Navigation website. Participants will be matched 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. Participants will also have access to a health resource library on the True North Peer Navigation website that contains local and national resources about prostate cancer.<br>* Other names: True North Peer Navigation;|
| Other: Active Waitlist Control<br>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. | Other: Active wait list control<br>* Participants in the active wait list control group will receive usual care and access to a health resource library on the True North Peer Navigation website that contains local and national resources about prostate cancer. After completion of the study, patients in the active wait list control group will be matched with a peer navigator.<br>* Other names: Web-based educational wait list control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, navigation, peer support, web-based, patient activation