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

NCT04218682 | Completed

• 1 other identifier: IRB 2018-2137
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Pediatric Cancer

Outcome Measures

Primary Outcomes (1)

• Resilience

  Resilience will be measured by participant responses to the Brief Resilience Scale (BRS), a 6-item measure with response options on 5-point Likert scale ranging from "1, strongly disagree" to "5, strongly agree" and total scores ranging from 6 to 30 (higher scores indicating greater resilience).

  Baseline to 14-week follow-up

Secondary Outcomes (14)

• Perceived benefit and burden

  Baseline to 14-week follow-up

• Life meaning and purpose

  Baseline to 14-week follow-up

• Fatigue

  Baseline to 14-week follow-up

• Pain Intensity

  Baseline to 14-week follow-up

• Positive affect

  Baseline to 14-week follow-up

Other Outcomes (1)

• Intervention satisfaction

  14-weeks post-enrollment

Study Arms (2)

Immediate Game Use

EXPERIMENTAL

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.

Behavioral: Shadow's Edge Mobile Application Gameplay

Wait-List Comparison Group

NO INTERVENTION

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.

Interventions

Shadow's Edge Mobile Application Gameplay BEHAVIORAL

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

Immediate Game Use

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• Silicon Valley Community Foundation: collaborator

Study Sites (1)

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

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Bonnie Essner, PhD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Psychologist

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 6, 2020
• Study Start: December 10, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)