ClinicalTrials.Veeva

Menu

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

Fred Hutchinson Cancer Center (FHCC) logo

Fred Hutchinson Cancer Center (FHCC)

Status

Active, not recruiting

Conditions

Thyroid Gland Carcinoma
Anatomic Stage II Breast Cancer AJCC v8
Clinical Stage III Cutaneous Melanoma AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Malignant Solid Neoplasm
Leukemia
Stage II Colorectal Cancer AJCC v8
Clinical Stage I Cutaneous Melanoma AJCC v8
Hematopoietic and Lymphoid Cell Neoplasm
Sarcoma
Clinical Stage II Cutaneous Melanoma AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Stage I Colorectal Cancer AJCC v8
Lymphoma
Invasive Malignant Neoplasm
Stage III Colorectal Cancer AJCC v8

Treatments

Other: Internet-Based Intervention
Other: Internet Mobile Technology
Other: Informational Intervention
Procedure: Supportive Care
Other: Questionnaire Administration

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04593277
10470 (Other Identifier)
NCI-2020-04792 (Registry Identifier)
RG1121029
U01CA246659 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

549 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

549 participants in 2 patient groups

Arm I (INSPIRE, telehealth care)
Experimental group
Description:
Patients receive a personalized SCP and use the INSPIRE mobile application. Patients may receive telehealth stepped care after 1 month.
Treatment:
Other: Questionnaire Administration
Procedure: Supportive Care
Other: Informational Intervention
Other: Internet Mobile Technology
Arm II (control website)
Active Comparator group
Description:
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.
Treatment:
Other: Questionnaire Administration
Other: Internet-Based Intervention

Trial documents
1

Trial contacts and locations

5

Loading...

Central trial contact

Study Intake

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems