CancerNCT04218682
Shadows Edge Mobile Developing Resilience in Adolescent and Young Adult Cancer Survivors
A study testing Shadow's Edge Mobile Application Gameplay in people with Cancer and Pediatric Cancer, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 24 years
- Conditions the study is for
- Cancer, Pediatric Cancer
- What is being tested?
- Shadow's Edge Mobile Application Gameplay
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2018to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Brain tumor history
- History of moderate to severe neurodevelopmental disorder (e.g., autism spectrum disorder)
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
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
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.
Read the 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
- Being tested
- Shadow's Edge Mobile Application Gameplay
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shadow's Edge Mobile Application GameplayBehavioural
6 weeks of individual, interactive game play of the Shadow's Edge mobile app.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 14-week follow-up
Secondary outcomes (14)
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.
Measured: Baseline to 14-week follow-up
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.
Measured: Baseline to 14-week follow-up
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).
Measured: Baseline to 14-week follow-up
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".
Measured: Baseline to 14-week follow-up
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).
Measured: Baseline to 14-week follow-up
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).
Measured: Baseline to 14-week follow-up
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).
Measured: Baseline to 14-week follow-up
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.
Measured: Baseline to 14-week follow-up
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.
Measured: Baseline to 14-week follow-up
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.
Measured: Baseline to 14 week follow-up
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.
Measured: Baseline to 14 week follow-up
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.
Measured: Baseline to 14 week follow-up
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".
Measured: Baseline to 14 week follow-up
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".
Measured: Baseline to 14 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start10 Dec 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Silicon Valley Community Foundation
- Responsible party
- Principal investigator, Bonnie Essner, PhD, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Bonnie Essner, PhD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218682
- Sponsor's protocol ID
- IRB 2018-2137
- Status last verified
- Nov 2024
- First submitted
- 2 Jan 2020
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04218682
- Acronym / sponsor ID
- IRB 2018-2137
- Conditions
- Cancer, Pediatric Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- Silicon Valley Community Foundation
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Game Use | Experimental | Behavioral: Shadow's Edge Mobile Application GameplayAYACS 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. |
| 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. |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Brain tumor history
- History of moderate to severe neurodevelopmental disorder (e.g., autism spectrum disorder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shadow's Edge Mobile Application Gameplay6 weeks of individual, interactive game play of the Shadow's Edge mobile app. | Behavioural | Immediate Game Use |
Primary outcome
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).
14 secondary outcomes
Perceived benefit and burden
Time frame: Baseline to 14-week follow-up
Life meaning and purpose
Time frame: Baseline to 14-week follow-up
Fatigue
Time frame: Baseline to 14-week follow-up
Pain Intensity
Time frame: Baseline to 14-week follow-up
Positive affect
Time frame: Baseline to 14-week follow-up
Depressive symptoms
Time frame: Baseline to 14-week follow-up
Anxiety
Time frame: Baseline to 14-week follow-up
Self-identity after cancer
Time frame: Baseline to 14-week follow-up
Identity status
Time frame: Baseline to 14-week follow-up
Daily pain intensity
Time frame: Baseline to 14 week follow-up
Daily fatigue
Time frame: Baseline to 14 week follow-up
Daily affect
Time frame: Baseline to 14 week follow-up
Sleep and sleep quality
Time frame: Baseline to 14 week follow-up
Relative daily activity
Time frame: Baseline to 14 week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonnie Essner, PhD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shadow's Edge Mobile Application Gameplay in people with Cancer and Pediatric Cancer, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience (time frame: Baseline to 14-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.