Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study
INSPIRE-AYA: A Multicenter Interactive Survivorship Program to Improve Healthcare Resources for Adolescent and Young Adult (AYA) Cancer Survivors
4 other identifiers
interventional
549
1 country
5
Brief Summary
This trial studies how well an interactive survivorship program works in improving healthcare resources in adolescent and young adult cancer survivors. By improving access to survivorship resources, health literacy, self-management skills, and support, an interactive survivorship program may help to improve adherence to adolescent and young adult healthcare guidelines and reduce cancer-related distress.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
October 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJanuary 23, 2026
January 1, 2026
3.2 years
October 6, 2020
January 22, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Change in distress score from baseline to 3 months
Will be assessed by Cancer and Treatment Distress (CTXD). The CTXD is a 22 item Likert type scale that contains 6 subscales: uncertainty, health burden, identity, medical demands, finances, and family strain. Scores on individual items range from 0 (none) to 3 (severe) distress related to an aspect of the cancer experience. Patients will meet the primary endpoint for lack of distress if they score \< 0.9 on the CTXD.
From baseline to 3 months
Change in distress score from baseline to 12 months
Will be assessed by Cancer and Treatment Distress (CTXD). The CTXD is a 22 item Likert type scale that contains 6 subscales: uncertainty, health burden, identity, medical demands, finances, and family strain. Scores on individual items range from 0 (none) to 3 (severe) distress related to an aspect of the cancer experience. Patients will meet the primary endpoint for lack of distress if they score \< 0.9 on the CTXD.
From baseline to 12 months
Secondary Outcomes (3)
Proportion of healthcare adherence (HCA)-all
At 12 months
Proportion of HCA-cardiometabolic surveillance (CM)
At 12 months
Proportion of HCA-cancer surveillance (SM)
At 12 months
Study Arms (2)
Arm I (INSPIRE, telehealth care)
EXPERIMENTALPatients receive a personalized SCP and use the INSPIRE mobile application. Patients may receive telehealth stepped care after 1 month.
Arm II (control website)
ACTIVE COMPARATORPatients receive access to a study-specific control website that has annotated links to existing resources for AYA survivors. After 12 months, patients receive a personalized SCP and have access to the digital INSPIRE intervention program without telehealth calls.
Interventions
Receive telehealth stepped care
Use INSPIRE mobile application
Ancillary studies
Eligibility Criteria
You may qualify if:
- Diagnosed with a first invasive malignancy of leukemia, lymphoma, melanoma, sarcoma, breast, thyroid, or colorectal cancer (stage 1-3 for solid tumors) between the ages of 15-39 years
- Current age \>= 18 when approached
- Currently within 1 to 5 years from the time of diagnosis
- Completed active treatment for disease \>= 6 months previously
- Received a therapeutic intervention (with curative intent if advanced stage disease) that included any of the following modalities: surgery, cytotoxic chemotherapy, biological or targeted agents, radiation therapy
- English proficiency adequate to complete assessments
- Access to email and smartphone mobile app and or internet
You may not qualify if:
- Diagnosed with a subsequent invasive malignancy other than non-melanoma skin cancer
- Received hematopoietic stem cell transplant
- Health issues prohibiting computer use or ability to comply with study procedures
- Residing in an institution or other living situation where health care decisions are not made by the participant (e.g., hospitalized, prisoners, living in a rehabilitation facility)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fred Hutchinson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (5)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
K. Scott Baker
Fred Hutch/University of Washington Cancer Consortium
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2020
First Posted
October 19, 2020
Study Start
October 23, 2022
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
January 23, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share