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

Not Applicable

Active, not recruiting

• Conditions: Clinical Stage II Cutaneous Melanoma AJCC v8; Hematopoietic and Lymphoid Cell Neoplasm; Invasive Malignant Neoplasm; Thyroid Gland Carcinoma; Lymphoma; Sarcoma; Stage I Colorectal Cancer AJCC v8; Stage II Colorectal Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8
• Interventions: Other: Internet-Based Intervention; Other: Internet Mobile Technology; Other: Questionnaire Administration; Procedure: Supportive Care; Other: Informational Intervention

• Registration Number: NCT04593277
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

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 Timeline

• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-19
• Study Start: 2022-10-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 549

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in distress score from baseline to 3 months	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.
Change in distress score from baseline to 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of healthcare adherence (HCA)-all	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.
Proportion of HCA-cardiometabolic surveillance (CM)	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.
Proportion of HCA-cancer surveillance (SM)	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.

Trial Locations

Locations (5)

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

University of Pennsylvania/Abramson Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States