NCT06193369

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable lymphoma

Timeline
7mo left

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress75%
Aug 2024Dec 2026

First Submitted

Initial submission to the registry

December 21, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

August 27, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

December 21, 2023

Last Update Submit

April 28, 2026

Conditions

Keywords

Young AdultsPost-Treatment Cancer SurvivorshipDigital HealthPatient NavigationPeer SupportPatient ActivationPilot RCT

Outcome Measures

Primary Outcomes (1)

  • Patient activation

    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 Outcomes (5)

  • Health utility

    0, 3 months

  • Supportive care needs

    0, 3 months

  • Anxiety

    0, 3 months

  • Depression

    0, 3 months

  • Social support

    0, 3 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Digital Peer Navigation

Waitlist Control

NO 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.

Interventions

Participants in the intervention group will receive ongoing support from a trained peer navigator for 3 months after completing treatment for cancer. Participants will be matched through a digital app 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. Patients will communicate with their peer navigator through digital direct messaging, videoconference or by telephone. Participants will also have access to a health resource library on the digital app that contains local and national resources about cancer.

Intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Are 18-40 years old;
  • Were diagnosed with breast or testicular cancer, lymphoma or sarcoma between the ages of 15-39 years old;
  • Have completed therapy within the last 12 months;
  • Are comfortable using the internet;
  • Have an active email address OR are willing to create one;
  • Able to read and speak English.

You may not qualify if:

  • Have metastatic disease or are receiving palliative end-of-life care;
  • Are not willing to be randomized.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

LymphomaBreast NeoplasmsTesticular NeoplasmsSarcomaPatient Participation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersNeoplasms, Connective and Soft TissuePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jackie Bender, PhD

    UHN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jackie Bender, PhD

CONTACT

Logan Meyers, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2023

First Posted

January 5, 2024

Study Start

August 27, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations