Melanoma Clinical Trial

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

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.

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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. Patients who do not have elevated distress or low cardiometabolic or cancer health care adherence are assigned to Group 0.

ARM I (INTERVENTION): Patients receive a personalized smart cell phone (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.

GROUP 0: Patients have access to the digital INSPIRE program and receive printed SCP materials without telehealth.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosed with a first invasive malignancy of leukemia, lymphoma, colorectal cancer, melanoma, or sarcoma (stage 1-3 for solid tumors) between the ages of 15-39 years
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
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 is for people with:

Melanoma

Estimated Enrollment:

1200

Study ID:

NCT04593277

Recruitment Status:

Recruiting

Sponsor:

Fred Hutchinson Cancer Center

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There are 5 Locations for this study

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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles California, 90095, United States More Info
Patricia A. Ganz
Contact
Patricia A. Ganz
Principal Investigator
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Ann H. Partridge
Contact
Ann H. Partridge
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Danielle N. Friedman
Contact
Danielle N. Friedman
Principal Investigator
University of Pennsylvania/Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States More Info
Linda Jacobs
Contact
Linda Jacobs
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Seattle Washington, 98109, United States More Info
Sheri Ballard
Contact
206-667-4222
[email protected]
Kevin Baker
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

1200

Study ID:

NCT04593277

Recruitment Status:

Recruiting

Sponsor:


Fred Hutchinson Cancer Center

How clear is this clinincal trial information?

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