Ignite Creation Date:
2024-05-06 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05041504
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2021-08-10
Brief Title:
A Web-based Peer Navigation Program for Men With Prostate Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Web-based Peer Navigation Program for Men With Prostate Cancer A Hybrid Effectiveness-Implementation Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mens 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 n120 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
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 n120 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Peer Navigation pRCT | OTHER | UHN | None |