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

NCT ID: NCT04218682

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-10
• Study Completion Date: 2020-04-01

Brief 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.

Detailed 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.

Conditions

Cancer; Pediatric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Immediate Game Use

AYACS randomly assigned to this arm will immediately play the Shadow's Edge Game following enrollment for a duration of 7 weeks. Following the designated 7-week game-play period, they will continue to have access to the game. They will continue to receive all usual care health care throughout and following the study.

Group Type: EXPERIMENTAL

Shadow's Edge Mobile Application Gameplay

Intervention Type: BEHAVIORAL

6 weeks of individual, interactive game play of the Shadow's Edge mobile app.

Wait-List Comparison Group

AYACS randomly assigned to this arm will begin to play the Shadow's Edge game 7 weeks following enrollment. They will continue to receive all usual health care throughout and following the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Shadow's Edge Mobile Application Gameplay

6 weeks of individual, interactive game play of the Shadow's Edge mobile app.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adolescent/young adults 13-24 years of age
• Adolescent/young adult English-speaking at a second grade level
• Parent/guardian English- or Spanish-speaking at a second grade level (for participants younger than 18 years of age)
• Patients with history of hematological malignancies (e.g., acute lymphoblastic leukemia) at maintenance phase of treatment or beyond or solid tumor patients (e.g., osteosarcoma) who have completed active treatment or cancer survivors with any form of malignancy history (excluding brain tumors) and are at least 2 years post-diagnosis of the malignancy
• Consistent access to a mobile phone and/or internet service

Exclusion Criteria

• Brain tumor history
• History of moderate to severe neurodevelopmental disorder (e.g., autism spectrum disorder)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Silicon Valley Community Foundation

OTHER

Sponsor Role: collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Bonnie Essner, PhD

Pediatric Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bonnie Essner, PhD

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

IRB 2018-2137

Identifier Type: -

Identifier Source: org_study_id