Cancer Clinical Trial - Shadows Edge Mobile Developing Resilience in

Status Recruiting

Clinical Trial Summary

This study evaluates the efficacy of an interactive mobile game, Shadow's Edge, on enhancing resilience, promoting identity development, and decreasing somatic symptoms among adolescent and young adult survivors of cancer.

Clinical Trial Description

Approximately 80% of youth treated for cancer during childhood will survive long-term; however, the majority of adolescent and young adult cancer survivors (AYACS) report at least one chronic health condition. These medical and cognitive-psychological late effects can disrupt or interfere with continual adaptation to post-treatment life, thereby negatively impacting identity formation and inhibiting AYACS from seeking fulfilling academic, career, and social relationship experiences. The Shadow's Edge mobile app was created for adolescent and young adults with complex medical conditions as an enjoyable and engaging digital, first-person perspective game that uses principles of narrative and creative arts therapies to encourage youth to reflect on, and create brief, developmentally-relevant narratives about, their life experiences. In this trial, investigators will conduct a two-arm, waitlist randomized controlled trial to evaluate the effectiveness of the Shadow's Edge game in promoting resilience and identify formation among AYACS. Participants will be 175 AYACS who receive clinical care in a large, pediatric cancer survivorship program. Data will be collected from medical records, mobile game play statistics, participant narratives and art created in the game platform, and participant responses to standardized assessments. Information gathered through this study will be used to establish initial game efficacy and to lead to Shadow's Edge game enhancements that will further improve acceptability and effectiveness of the game. The ultimate goal of this project is to provide a freely accessible, enjoyable and engaging self-led game that may bolster resilience resources, improve quality of life, and promote identity formation among adolescents and young adults with complex medical conditions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04218682
Study type	Interventional
Source	Ann & Robert H Lurie Children's Hospital of Chicago
Contact	Noor Abdelfattah
Phone	312-227-5187
Email	bessner@luriechildrens.org
Status	Recruiting
Phase	N/A
Start date	December 10, 2018
Completion date	April 1, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Shadows Edge Mobile Developing Resilience in Adolescent and Young Adult Cancer Survivors

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms