- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04218682
Shadows Edge Mobile Developing Resilience in Adolescent and Young Adult Cancer Survivors
Narrating Their Story: Shadow's Edge Mobile Game Use to Enhance Resilience and Identity Formation Among Adolescent and Young Adult Survivors of Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Noor Abdelfattah
- Phone Number: 312-227-5187
- Email: bessner@luriechildrens.org
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Recruiting
- Ann & Robert H. Lurie Children's Hospital of Chicago
-
Contact:
- Amanda Barkho, BA
-
Principal Investigator:
- Bonnie Essner, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
6 weeks of individual, interactive game play of the Shadow's Edge mobile app.
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No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resilience
Time Frame: Baseline to 14-week follow-up
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived benefit and burden
Time Frame: Baseline to 14-week follow-up
|
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
|
Life meaning and purpose
Time Frame: Baseline to 14-week follow-up
|
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
|
Fatigue
Time Frame: Baseline to 14-week follow-up
|
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
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Pain Intensity
Time Frame: Baseline to 14-week follow-up
|
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
|
Positive affect
Time Frame: Baseline to 14-week follow-up
|
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
|
Depressive symptoms
Time Frame: Baseline to 14-week follow-up
|
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
|
Anxiety
Time Frame: Baseline to 14-week follow-up
|
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
|
Self-identity after cancer
Time Frame: Baseline to 14-week follow-up
|
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
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Identity status
Time Frame: Baseline to 14-week follow-up
|
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
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Daily pain intensity
Time Frame: Baseline to 14 week follow-up
|
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
|
Daily fatigue
Time Frame: Baseline to 14 week follow-up
|
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
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Daily affect
Time Frame: Baseline to 14 week follow-up
|
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
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Sleep and sleep quality
Time Frame: Baseline to 14 week follow-up
|
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".
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Baseline to 14 week follow-up
|
Relative daily activity
Time Frame: Baseline to 14 week follow-up
|
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".
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Baseline to 14 week follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention satisfaction
Time Frame: 14-weeks post-enrollment
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Bonnie Essner, PhD, Ann & Robert H Lurie Children's Hospital of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB 2018-2137
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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