Clinical trial NCT05041504: A Web-based Peer Navigation Program for Men With Prostate Cancer
Official title: A Web-based Peer Navigation Program for Men With Prostate Cancer: A Hybrid Effectiveness-Implementation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
navigation
peer support
web-based
patient activation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: Dalhousie University
name: University of Toronto
name: Canadian Cancer Society (CCS)
name: Canadian Partnership Against Cancer
name: Movember Foundation
name: Walnut Foundation
name: Prostate Cancer Support - Toronto
name: Prostate Cancer Group - Burnaby
First posted: 2021-09-13
Enrollment: 184
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Patient Activation at 3 months
timeFrame: 0, 3 months
Secondary outcomes:
measure: Change in Patient Activation at 6 months
timeFrame: 0, 6 months
measure: Change in Supportive Care Needs
timeFrame: 0, 3, 6 months
measure: Change in Health-Related Quality of Life
timeFrame: 0, 3, 6 months
measure: Change in Prostate Cancer Quality of Life
timeFrame: 0, 3, 6 months
measure: Change in Anxiety
timeFrame: 0, 3, 6 months
measure: Change in Depression
timeFrame: 0, 3, 6 months
measure: Change in Social Support
timeFrame: 0, 3, 6 months
measure: Change in Fear of Cancer Recurrence
timeFrame: 0, 3, 6 months
Other outcomes:
measure: Quality-adjusted life year
timeFrame: 0,3,6 months
measure: Total healthcare costs
timeFrame: 3,6 months
measure: Intervention cost
timeFrame: 3 years
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer - Vancouver
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Sydney
country: Canada
facility: Cape Breton Regional Hospital
state: Nova Scotia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Jackie Bender, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.