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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04218682
• Other study ID #: IRB 2018-2137
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: January 2020
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Noor Abdelfattah
• Phone: 312-227-5187
• Email: bessner[@]luriechildrens.org
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 24 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cancer
• Pediatric Cancer

Intervention

Behavioral:
• Shadow's Edge Mobile Application Gameplay
6 weeks of individual, interactive game play of the Shadow's Edge mobile app.

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago	Silicon Valley Community Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention satisfaction	9-item measure created for this study, assessing participant enjoyment with the game intervention, elements of the game experience, and their perception that playing the game affected their emotions or behaviors. Range from 1=not at all to 5=very much	14-weeks post-enrollment
Primary	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	Perceived benefit and burden	Perceived benefit and burden associated with the participant's cancer experience will be assessed with the 20-item Benefit and Burden Scale for Children. Participants rate statements on a five-point Likert scale, ranging from "1, not at all" to "5, very much, with higher scores on the 10-item Benefit scale indicating greater benefit-finding and higher scores on the 10-item Burden scale indicating greater perceived burden of the illness. Scores on each subscale range from 10 - 50.	Baseline to 14-week follow-up
Secondary	Life meaning and purpose	Meaning and purpose will be measured by the PROMIS Pediatric Meaning and Purpose Short Form-8. Items are rated on a five-point Likert scale ranging from "1, not at all" to "5, very much", with total scores ranging from eight to 40 (higher scores indicating greater sense of reason for living, goal direction, and hopefulness).; ...scores range from 8 to 40 (higher scores indicate greater fear, anxious misery, and hyperarousal).; The 8-item scale of depressive symptoms has scores ranging from 8 to 40 with higher scores indicating greater depressive symptoms. Total anxiety and total depression T-scores will be used in analyses.	Baseline to 14-week follow-up
Secondary	Fatigue	Fatigue over the past seven days will be measured with the PROMIS Pediatric Fatigue Short Form-10. Items are rated on a five-point Likert scale ranging from "1, never" to "5, almost always", with total scores ranging from 10 to 100 (higher scores indicating greater subjective feeling of tiredness, exhaustion and perception that fatigue interferes with daily function).	Baseline to 14-week follow-up
Secondary	Pain Intensity	Pain intensity over the past seven days will be measured with the PROMIS Pediatric Numeric Rating Scale - Pain Intensity, measured on an 11-point scale with anchors "0, No Pain" to "10, worst pain you can think of".	Baseline to 14-week follow-up
Secondary	Positive affect	Positive affect will be assessed by the PROMIS Pediatric Positive Affect Short Form-8. Items are rated on a five-point Likert scale ranging from "1, never" to "5, always", with total scores ranging from eight to 40 (higher scores indicating greater momentary positive affect, such as contentment, happiness, engagement, an excitement).	Baseline to 14-week follow-up
Secondary	Depressive symptoms	Depressive symptoms will be assessed by the PROMIS Pediatric Depressive Symptoms Short Form-8. Items are rated on a five-point Likert scale ranging from "1, never" to "5, almost always", with total scores ranging from eight to 40 (higher scores indicating greater negative mood, self-evaluation, and cognitions).	Baseline to 14-week follow-up
Secondary	Anxiety	Anxiety will be assessed by the PROMIS Pediatric Anxiety Short Form-8. Items are rated on a five-point Likert scale ranging from "1, never" to "5, almost always", with total scores ranging from eight to 40 (higher scores indicating greater fear, hyperarousal, and anxiety-associated somatic symptoms).	Baseline to 14-week follow-up
Secondary	Self-identity after cancer	Self-identity after cancer will be assessed with a four-item measure in which participants rate the degree to which they identify with four descriptions of relating to their past cancer experience. The five-point Likert scale ranges from "1, not at all" to "5, very much". Each item is used scored and used independently.	Baseline to 14-week follow-up
Secondary	Identity status	Identity status will be assessed via the 64-item Extended Objective Measure of Ego Identity Status-2. Participants rate each item on a 6-point Likert scale ranging from "1, strongly disagree" to "6, strongly agree", with total scores ranging from score of 64 to 384 (when measured on a continuous). Scores from this measure will be used to categorize participant identity status into one of four theoretically and empirically derived identity statuses and will also be used as a continuous variable, with higher scores indicating more mature identity status.	Baseline to 14-week follow-up
Secondary	Daily pain intensity	Daily pain intensity over the previous 24 hours will be measured with the PROMIS Pediatric Numeric Rating Scale - Pain Intensity v 1.0, measured on an 11-point scale with anchors "0, No Pain" to "10, worst pain you can think of". Daily pain intensity will be assessed over a 10-day period via daily diary.	Baseline to 14 week follow-up
Secondary	Daily fatigue	Daily fatigue over the past 24 hours will be measured with an 11-point 0 - 10 Numeric rating scale ranging from anchors of "not at all tired" to "very tired". Daily fatigue will be assessed over a 10-day period via daily diary.	Baseline to 14 week follow-up
Secondary	Daily affect	Daily affect over the past 24 hours will be assessed with Positive and Negative Affect Scale (PANAS), a 20-item measure in which participants rate the degree to which they have experienced each positive and negative emotion on a five-point Likert scale ranging from "1, Very slightly or Not at all" to "5, Extremely". Total scores for the Positive Affect Subscale and Negative Affect subscale range from 1 to 10. A "relative negative mood" index will be calculated for each participant whereby days in which the participant's negative affect score was greater than .5 standard deviations from that participant's 7-day mean negative affect scores will be designated as a "relative negative mood" day. Similarly, a "relative positive mood" index will be calculated for each participant whereby days in which the participant's positive affect score was greater than .5 standard deviations from that participant's 7-day mean positive affect scores will be designated as a "relative positive mood" day.	Baseline to 14 week follow-up
Secondary	Sleep and sleep quality	Each day for a consecutive 10-day period, participants will report the time they went to bed the previous night, the time they attempted to fall asleep, sleep onset delay, number of night awakenings, and that days' time that they awoke in the morning, time they got out of bed, the number of naps and duration of daytime sleep that day. They will also provide a subjective sleep quality rating using an 11-point 0 - 10 Numeric Rating Scale ranging from "0, extremely poor sleep" to "10, extremely good sleep".	Baseline to 14 week follow-up
Secondary	Relative daily activity	Each day for a consecutive 10-day period, participants' relative daily activity will be assessed with a form created for this study. Participants will rate the degree to which they engaged in five activities relative to their typical activity level. Responses are rated on an 11-point 0 - 10 NRS from "no, much less than usual" to "yes, much more time than usual".	Baseline to 14 week follow-up