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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05041504
• Other study ID #: 21-5126
• Secondary ID: Peer Navigation
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 13, 2022
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Peer navigation
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.

Other:
• Active wait list control
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.

Locations

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

Sponsors (10)

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

Country where clinical trial is conducted

Canada, 

References & 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. — 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.

Outcome

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

External Links

•   TrueNORTH Peer Navigation intervention website