NCT05041504

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started May 2022

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

May 13, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

August 10, 2021

Last Update Submit

January 7, 2026

Conditions

Prostate Cancer

Keywords

prostate cancernavigationpeer supportweb-basedpatient activation

Outcome Measures

Primary Outcomes (1)

  • Patient Activation at 3 months

    The primary outcome will be Patient Activation at 3 months. Patient Activation will be measured using the Patient Activation Measure (PAM). Higher scores represent a better outcome.

    0, 3 months

Secondary Outcomes (8)

  • Patient Activation at 6 months

    0, 6 months

  • Supportive Care Needs

    0, 3, 6 months

  • Health-Related Quality of Life

    0, 3, 6 months

  • Prostate Cancer Quality of Life

    0, 3, 6 months

  • Anxiety

    0, 3, 6 months

  • +3 more secondary outcomes

Other Outcomes (3)

  • Quality-adjusted life year

    0,3,6 months

  • Total healthcare costs

    3,6 months

  • Intervention cost

    3 years

Study Arms (2)

Intervention

EXPERIMENTAL

Participants assigned to the intervention arm will receive the True North Peer Navigation intervention.

Behavioral: Peer navigation

Active Waitlist Control

OTHER

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

Interventions

Peer navigationBEHAVIORAL

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.

Also known as: True North Peer Navigation
Intervention
Active wait list controlOTHER

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.

Also known as: Web-based educational wait list control
Active Waitlist Control

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Has been diagnosed with advanced metastatic disease.
  • Is receiving palliative care.
  • Is not willing to be randomized.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

BC Cancer - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

Location

Related Publications (3)

  • 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.

    PMID: 32613373BACKGROUND

  • 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.

    PMID: 31616997BACKGROUND

  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsPatient Participation

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jackie Bender, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2021

First Posted

September 13, 2021

Study Start

May 13, 2022

Primary Completion

March 18, 2024

Study Completion

December 1, 2024

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)