Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study

January 22, 2026 updated by: Fred Hutchinson Cancer Center

INSPIRE-AYA: A Multicenter Interactive Survivorship Program to Improve Healthcare Resources for Adolescent and Young Adult (AYA) Cancer Survivors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OUTLINE: Patients who have one or more elevated distress or low cardiometabolic or cancer health care adherence are randomized to Arm I or II.

ARM I (INTERVENTION): Patients receive a personalized Survivorship Care Plan (SCP) and use the Interactive Survivorship Program to Improve Healthcare Resources (INSPIRE) mobile application. Patients may receive telehealth stepped care after 1 month.

ARM II (CONTROL): Patients receive access to a study-specific control website that has annotated links to existing resources for adolescent and young adult (AYA) survivors. After 12 months, patients receive a personalized SCP and have access to the digital INSPIRE intervention program without telehealth calls.

Study Type

Interventional

Enrollment (Actual)

549

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA / Jonsson Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania/Abramson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Does not complete baseline patient reported outcome (PRO) assessment items required to determine stratification or whether the survivor meets inclusion and exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (INSPIRE, telehealth care)
Patients receive a personalized SCP and use the INSPIRE mobile application. Patients may receive telehealth stepped care after 1 month.
Other: Questionnaire Administration
Ancillary studies
Other: Internet Mobile Technology
Use INSPIRE mobile application
Other Names:
  • www-mobile
Procedure: Supportive Care
Receive telehealth stepped care
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive
Other: Informational Intervention
Receive printed SCP materials
Active Comparator: Arm II (control website)
Patients 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.
Other: Questionnaire Administration
Ancillary studies
Other: Internet-Based Intervention
Access to a study-specific control website

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in distress score from baseline to 3 months
Time Frame: 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
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of healthcare adherence (HCA)-all
Time Frame: At 12 months
Patients will meet HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-all.
At 12 months
Proportion of HCA-cardiometabolic surveillance (CM)
Time Frame: At 12 months
Patients will meet each HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-CM.
At 12 months
Proportion of HCA-cancer surveillance (SM)
Time Frame: At 12 months
Patients will meet each HCA endpoint if their percent of recommended screenings obtained within the past 12 months is >= 80% for HCA-SM.
At 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: K. Scott Baker, Fred Hutch/University of Washington Cancer Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2022

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

October 6, 2020

First Submitted That Met QC Criteria

October 16, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG1121029
  • NCI-2020-04792 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 10470 (Fred Hutch/University of Washington Cancer Consortium)
  • U01CA246659 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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