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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT04218682
Study groupRoleWhat they receive
Immediate Game UseExperimentalAYACS 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 GroupNo interventionAYACS 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.

  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).

    Measured: Baseline to 14-week follow-up

Secondary outcomes (14)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.

  1. First posted6 Jan 2020
  2. Study start10 Dec 2018
  3. Primary completion1 Apr 2020
  4. Study completion1 Apr 2020

Resources

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)
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

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.

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