Digital Peer Navigation for Cancer

Overseen By Logan Meyers, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Metastatic disease, Palliative care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

138 Participants Needed

Trial Summary

What is the purpose of this trial?

Adolescents and young adults (AYA) diagnosed with cancer experience unique challenges after completing treatment and face distinct barriers to optimal care and support. These challenges include higher levels of symptom burden and treatment complications, interrupted education, careers and relationships, and financial hardship. AYA lack access to peers, relevant information and emotional support, and report gaps in care when dealing with these difficult challenges. Digital peer navigation could help to address the needs of AYA and overcome barriers to care and support. The PI developed True North Peer Navigation (TrueNTH-PN), an evidence-based digital peer navigation program for men with prostate cancer and online peer navigator training course. The goal of this project is to adapt TrueNTH-PN for AYA and evaluate its feasibility to overcome barriers to care and support, and enhance patient activation among AYA during the challenging post-treatment phase. In partnership with AYA cancer survivors, the Canadian Cancer Society, Young Adult Cancer Canada, a digital app design firm and technology provider, our cross-Canada team will: (1) Adapt and evaluate the usability of the TrueNTH-PN app for AYA; (2) Adapt and evaluate the effectiveness of the Peer Navigator Training Course for AYA; and (3) Determine the feasibility, acceptability and preliminary effectiveness of the new AYA-PN program among post-treatment AYA cancer survivors. This project will produce an innovative solution to an important service gap in the lives of AYA with cancer. It has the potential to address the support needs of AYA, overcome barriers to care, and empower AYA to take proactive role in managing their health. In addition, it will give rise to AYA peer navigators with specialized skills, which could fill gaps in disrupted education and career paths, and help to attain future goals.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on digital peer support for cancer survivors, so it's best to check with the trial coordinators for specific guidance.

What data supports the effectiveness of the treatment Digital Peer Navigation for cancer?

Research on web-based peer navigation for prostate cancer patients shows that it is feasible and well-received, with improvements in patient activation and quality of life. This suggests that digital peer navigation can effectively support cancer patients by addressing their needs and encouraging proactive health management. ^{1 2 3 4 5}

Is Digital Peer Navigation safe for humans?

The study on True North Peer Navigation, a web-based peer navigation program for men with prostate cancer, showed it was feasible and well-received, with high satisfaction rates among participants. There were no safety concerns reported in the study, suggesting it is generally safe for humans. ^{1 2 3 6 7}

How is Digital Peer Navigation different from other cancer treatments?

Digital Peer Navigation is unique because it uses specially trained peers to guide and support cancer patients through a web-based platform, focusing on improving access to care and reducing barriers, unlike traditional treatments that primarily focus on medical interventions. ^{1 2 3 5 8}

Research Team

Jackie Bender, PhD

Principal Investigator

UHN

Eligibility Criteria

This trial is for young adults aged 18-40 who were diagnosed with breast or testicular cancer, lymphoma, or sarcoma at ages 15-39. Participants should have finished initial cancer treatment within the last 6 months, be comfortable using the internet and email, and able to read and speak English.

Inclusion Criteria

I was diagnosed with breast, testicular cancer, lymphoma, or sarcoma between 15-39 years old.

You feel at ease using the internet.

I have an active email address or am willing to create one.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Adaptation and Evaluation

Adapt and evaluate the usability of the TrueNTH-PN app and peer navigator training course for AYA

8-12 weeks

Multiple virtual sessions for app testing and training

Pilot RCT

Conduct a pilot RCT of the AYA-PN program compared to waitlist control to determine feasibility, acceptability, and preliminary effectiveness

3 months

Baseline and 3-month follow-up assessments

Follow-up

Participants are monitored for outcomes such as patient activation, supportive care needs, and quality of life

3 months

Treatment Details

Interventions

• Digital Peer Navigation

Trial Overview The study tests a digital peer navigation program adapted from TrueNTH-PN for adolescents and young adults (AYA) post-cancer treatment. It aims to evaluate its usability, effectiveness in training peer navigators, feasibility, acceptability among AYA survivors.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Participants assigned to the intervention arm will the receive digital peer navigation intervention.

Group II: Waitlist Control Active Control 1 Intervention

Participants assigned to the control arm will receive usual care. After completion of the study, they will have the option to receive the digital peer navigation intervention.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Canadian Cancer Society (CCS)

Collaborator

Trials

84

Recruited

42,100+

Young Adult Cancer Canada

Collaborator

Trials

1

Recruited

100+

Findings from Research

The True North Peer Navigation program for men with prostate cancer and their caregivers demonstrated high feasibility and acceptability, with a recruitment rate of 57.9% and a post-questionnaire completion rate of 66.7%.

Participants showed significant improvements in activation, quality of life, and support needs after 3 months, indicating the program's potential effectiveness, which warrants further investigation in a randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Peer Navigation for Men with Prostate Cancer and Their Family Caregivers: A Pilot Feasibility Study. Bender, JL., Flora, PK., Soheilipour, S., et al.[2023]

The TrueNTH Peer Navigation Training Program (PNTP) was found to be highly acceptable and effective for training prostate cancer survivors as peer navigators, with a satisfaction score of 9.4 out of 10 and a high usability rating of 84.5 out of 100.

Participants showed significant improvements in understanding learning objectives, self-efficacy, and eHealth literacy, indicating that the program effectively enhanced their knowledge and confidence in supporting others with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training prostate cancer survivors and caregivers to be peer navigators: a blended online/in-person competency-based training program. Bender, JL., Flora, PK., Milosevic, E., et al.[2021]

Nurse navigation in cancer care has been associated with significant improvements in clinical outcomes, including reduced distress, anxiety, and depression among patients.

Patients receiving nurse navigation experienced better symptom management, improved physical conditioning, enhanced quality of life, and quicker initiation of treatment, highlighting the effectiveness of this approach in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. Rodrigues, RL., Schneider, F., Kalinke, LP., et al.[2022]

A standardized national training program for patient navigators (PNs) was successfully implemented, attended by 116 PNs from 85 cities, aimed at reducing cancer health disparities for medically underserved populations.

The training showed significant efficacy, with overall improvements in posttest scores compared to pretest scores, particularly among participants with higher education levels or more work experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A national patient navigator training program. Calhoun, EA., Whitley, EM., Esparza, A., et al.[2021]

In a study of 438 cancer patients, patient navigation (PN) did not significantly improve overall treatment completion time, satisfaction with care, or psychological distress compared to usual care.

However, socially disadvantaged patients who received PN reported higher satisfaction with their care, indicating that PN may be beneficial for specific groups, despite no overall benefits observed in the primary analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation for breast and colorectal cancer treatment: a randomized trial. Fiscella, K., Whitley, E., Hendren, S., et al.[2021]

The National Patient Navigation Leadership Summit, held by the American Cancer Society in March 2010, aimed to create a consensus on key outcomes to measure the effectiveness of patient navigation in cancer care.

The Summit brought together a diverse group of experts to propose core metrics that can evaluate the impact of patient navigation on both individual patients and broader populations, providing a framework for future navigation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the impact and potential of patient navigation: proposed common metrics and beyond. Esparza, A., Calhoun, E.[2021]

The original patient navigation programs effectively combined community involvement and culturally sensitive care coordination to address disparities in cancer care, particularly for racial and ethnic minorities.

These programs functioned as a system rather than relying on individual navigators, with a structured team of navigators and directors working together to remove barriers and facilitate patient access to care, highlighting the importance of administrative support and community engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of the original patient navigation programs to reduce disparities in the diagnosis and treatment of breast cancer. Vargas, RB., Ryan, GW., Jackson, CA., et al.[2011]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Web-Based Peer Navigation for Men with Prostate Cancer and Their Family Caregivers: A Pilot Feasibility Study. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Training prostate cancer survivors and caregivers to be peer navigators: a blended online/in-person competency-based training program. [2021]

3. Brazil pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Building a navigation system to reduce cancer disparities among urban Black older adults. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A national patient navigator training program. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Patient navigation for breast and colorectal cancer treatment: a randomized trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Measuring the impact and potential of patient navigation: proposed common metrics and beyond. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Characteristics of the original patient navigation programs to reduce disparities in the diagnosis and treatment of breast cancer. [2011]