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

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

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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