- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06193369
Digital Peer Navigation for Adolescents and Young Adults With Cancer
Digital Peer Navigation for Adolescents and Young Adults With Cancer: A Feasibility Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Adolescent and young adult (AYA) cancer survivors experience unique challenges and face distinct barriers to optimal post-treatment survivorship care and support which can impede their recovery. These include high levels of symptom burden and treatment-related complications, interrupted education, careers and relationships, and financial toxicity. AYA lack access to peers, relevant information and emotional support, and report gaps in care when dealing with these difficult challenges. Previous research has shown that patient navigation improves the timeliness of care and support, and reduces healthcare costs. Engaging trained volunteer cancer survivors as peer navigators minimizes resource requirements, is preferred by AYA over professional support, and benefits the navigator by improving their psychosocial health. The PI developed True North Peer Navigation (TrueNTH-PN), an evidence-based digital peer navigation program for men with prostate cancer and online competency-based peer navigator training course. Patients are 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 a proactive approach to health. TrueNTH-PN has been shown to be highly acceptable to prostate cancer patients and peer navigators, and associated with improvements in patient activation, social support and quality of life.
Aim: This study aims to adapt and evaluate a digital peer navigation program for AYA cancer survivors to overcome barriers to care and support, and enhance patient activation during the post-treatment survivorship phase.
Specific Objectives: This 3-phase project will: (1) Adapt and evaluate the usability of the TrueNTH-PN app for AYA; (2) Adapt and evaluate the effectiveness of TrueNTH-PN peer navigator training course for AYA; and (3) Determine the feasibility, acceptability and preliminary effectiveness of the new AYA peer navigation program (AYA-PN).
Methods: We will adopt an iKT approach with patients, Canadian Cancer Society and Young Adult Cancer Canada as partners, along with a digital app design firm and technology provider. For objective 1, informed by Barrera and Castro's cultural adaptation framework and user-centred design, we will engage AYA in a critical assessment of the existing TrueNTH-PN app to identify areas in need of adaptation for AYA, co-design content and processes adaptations, and conduct user-testing. For objective 2, we will tailor and validate the relevance of the course content for AYA; recruit, screen and train 20 AYA cancer survivors to be peer navigators; and informed by the Kirkpatrick training program framework, evaluate the training course using pre-post questionnaires to assess knowledge and self-efficacy for navigator competencies. For objective 3, we will conduct a pilot RCT of the new AYA-PN program compared to wait list control with an embedded process evaluation to determine: 1) feasibility; 2) acceptability; and 3) preliminary effectiveness on patent activation, supportive care needs, quality of life, anxiety/depression, social support and post-traumatic growth. One hundred thirty eight AYA (n=69 per arm) will be recruited after completing treatment. Outcomes will be assessed at baseline (T0) and 3-months (T1). In addition, we will evaluate patient-navigator interactions, app usage, and cost-effectiveness, and conduct semi-structured interviews with patients and navigators informed by the Consolidated Framework for Implementation Research to capture experiences, explore mechanisms of action and identify implementation barriers and facilitators.
Significance: This study will produce an innovative solution to an important service gap in the lives of AYA with cancer. It is highly aligned with the CCS priority in AYA survivorship care, the Pan-Canadian Cancer Survivorship Research Agenda, and the SPOR mandate to make research more responsive to the needs of Canadians.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jackie Bender, PhD
- Phone Number: 416-581-8606
- Email: Jackie.Bender@uhn.ca
Study Contact Backup
- Name: Logan Meyers, MSc
- Phone Number: 416-581-7652
- Email: logan.meyers@uhn.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2C4
- Recruiting
- University Health Network
-
Contact:
- Jackie Bender, PhD Scientist
- Phone Number: 416-581-8606
- Email: jackie.bender@uhn.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- Have metastatic disease or are receiving palliative end-of-life care;
- Are not willing to be randomized.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Participants assigned to the intervention arm will the receive digital peer navigation intervention.
|
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.
|
|
No Intervention: Waitlist Control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient activation
Time Frame: 0, 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health utility
Time Frame: 0, 3 months
|
Health utility will be measured with the EQ-5D.
|
0, 3 months
|
|
Supportive care needs
Time Frame: 0, 3 months
|
Supportive care needs will be measured with the Supportive Care Needs Survey (SCNS-SF34).
|
0, 3 months
|
|
Anxiety
Time Frame: 0, 3 months
|
Anxiety will be measured with the Generalized Anxiety Disorder scale (GAD-7).
|
0, 3 months
|
|
Depression
Time Frame: 0, 3 months
|
Depression will be measured with the Patient Health Questionnaire (PHQ-9).
|
0, 3 months
|
|
Social support
Time Frame: 0, 3 months
|
Social support will be measured with the ENRICHD Social Support Instrument (ESSI).
|
0, 3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jackie Bender, PhD, UHN
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Male Urogenital Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Endocrine Gland Neoplasms
- Gonadal Disorders
- Skin Diseases
- Breast Diseases
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms, Connective and Soft Tissue
- Testicular Diseases
- Behavior
- Skin and Connective Tissue Diseases
- Hemic and Lymphatic Diseases
- Treatment Adherence and Compliance
- Health Behavior
- Patient Acceptance of Health Care
- Breast Neoplasms
- Lymphoma
- Sarcoma
- Testicular Neoplasms
- Patient Participation
Other Study ID Numbers
- 22-5552
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sarcoma
-
Albert Einstein College of MedicineNational Cancer Institute (NCI)TerminatedUterine Corpus Leiomyosarcoma | Stage IIA Uterine Sarcoma | Stage IIB Uterine Sarcoma | Stage IIIA Uterine Sarcoma | Stage IIIB Uterine Sarcoma | Stage IIIC Uterine Sarcoma | Stage IVA Uterine Sarcoma | Stage IVB Uterine Sarcoma | Stage IA Uterine Sarcoma | Stage IB Uterine Sarcoma | Stage IC Uterine SarcomaUnited States
-
Children's Oncology GroupActive, not recruitingMetastatic Ewing Sarcoma | CIC-Rearranged Sarcoma | Round Cell Sarcoma With EWSR1-non-ETS Fusion | Metastatic High Grade Sarcoma | Sarcoma With BCOR Genetic Alterations | Metastatic Undifferentiated Round Cell Sarcoma | Metastatic Undifferentiated Sarcoma, Not Otherwise SpecifiedUnited States
-
AIDS Malignancy ConsortiumNational Cancer Institute (NCI)Not yet recruitingSkin Kaposi Sarcoma | AIDS-Related Kaposi SarcomaUnited States
-
Mohammed M MilhemGenentech, Inc.CompletedSarcoma | Soft Tissue Sarcoma | Metastatic Sarcoma | Locally Advanced Sarcoma | Unresectable SarcomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedBone Sarcoma | Retroperitoneal Sarcoma | Adult Soft Tissue SarcomaUnited States
-
National Cancer Institute (NCI)RecruitingMetastatic Alveolar Soft Part Sarcoma | Unresectable Alveolar Soft Part Sarcoma | Advanced Soft Tissue Sarcoma | Advanced Alveolar Soft Part Sarcoma | Refractory Alveolar Soft Part SarcomaUnited States
-
National Cancer Institute (NCI)CompletedRhabdomyosarcoma | Synovial Sarcoma | Ewing's Sarcoma | MPNST | High-risk SarcomaUnited States
-
David DickensWithdrawnSoft Tissue Sarcoma | Bone Sarcoma | Unresectable Soft Tissue Sarcoma | Metastatic Soft-tissue Sarcoma | Metastatic Bone Sarcoma | Unresectable Bone SarcomaUnited States
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma | Stage IIA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma
-
National Cancer Institute (NCI)CompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Adult Synovial SarcomaUnited States
Clinical Trials on Digital Peer Navigation
-
University of California, Los AngelesCompleted
-
University of California, San FranciscoNational Institutes of Health (NIH); ANOVA Health InstituteCompleted
-
University of California, San FranciscoNational Institute of Mental Health (NIMH)Completed
-
Montefiore Medical CenterCenters for Disease Control and PreventionCompletedHIV-1-infection | Pre-exposure ProphylaxisUnited States
-
University of Colorado, DenverNational Institute of Mental Health (NIMH); University of Pittsburgh; University... and other collaboratorsRecruitingMental Health | Family Health | Mental Disorder, ChildUnited States
-
Michigan State UniversityBrown UniversityCompletedIndividuals With Serious Mental Illness Leaving JailsUnited States
-
Brigham and Women's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Recruiting
-
Johns Hopkins Bloomberg School of Public HealthNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingPrEP | HIV Prevention | Women | Intimate Partner Violence (IPV)United States
-
CrescentCareRecruiting
-
University of MichiganCompletedGlucose Metabolism Disorders | Metabolic Diseases | Diabetes Mellitus | Endocrine System DiseasesUnited States