Clinical trial NCT04218682: Shadows Edge Mobile Developing Resilience in Adolescent and Young Adult Cancer Survivors
Official title: Narrating Their Story: Shadow's Edge Mobile Game Use to Enhance Resilience and Identity Formation Among Adolescent and Young Adult Survivors of Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Pediatric Cancer
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: Silicon Valley Community Foundation
First posted: 2020-01-06
Enrollment: 177
Sex: ALL
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a waitlist randomized controlled study in which participants are randomly assigned to immediately begin to play the game (intervention) following enrollment versus wait 6 weeks to play the game following study enrollment. Participants will continue to receive all clinical care as usual throughout and following the study.
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Resilience
timeFrame: Baseline to 14-week follow-up
Secondary outcomes:
measure: Perceived benefit and burden
timeFrame: Baseline to 14-week follow-up
measure: Life meaning and purpose
timeFrame: Baseline to 14-week follow-up
measure: Fatigue
timeFrame: Baseline to 14-week follow-up
measure: Pain Intensity
timeFrame: Baseline to 14-week follow-up
measure: Positive affect
timeFrame: Baseline to 14-week follow-up
measure: Depressive symptoms
timeFrame: Baseline to 14-week follow-up
measure: Anxiety
timeFrame: Baseline to 14-week follow-up
measure: Self-identity after cancer
timeFrame: Baseline to 14-week follow-up
measure: Identity status
timeFrame: Baseline to 14-week follow-up
measure: Daily pain intensity
timeFrame: Baseline to 14 week follow-up
measure: Daily fatigue
timeFrame: Baseline to 14 week follow-up
measure: Daily affect
timeFrame: Baseline to 14 week follow-up
measure: Sleep and sleep quality
timeFrame: Baseline to 14 week follow-up
measure: Relative daily activity
timeFrame: Baseline to 14 week follow-up
Other outcomes:
measure: Intervention satisfaction
timeFrame: 14-weeks post-enrollment
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Bonnie Essner, PhD
role: PRINCIPAL_INVESTIGATOR
References: