Resilience Mobile App for Teens and Young Adults With Cancer

Study Overview
=================
Brief Summary
-----------------
The goal of this pilot trial is to examine whether a mobile app version of the Promoting Resilience in Stress Management (PRISM) intervention is acceptable, easy to use, and helps improve quality of life and mental health symptoms.

Detailed Description
-----------------
Adolescents and Young Adults (AYAs) with cancer are at risk of distress, anxiety, depression, and poor quality of life. The use of mobile applications for psychosocial symptom self-management is appealing to this demographic population but this has not yet been developed and tested. PRISM is a novel, brief, evidence-based 1:1 intervention that teaches stress management, goal-setting, meaning making, cognitive-behavioral, and mindfulness strategies. Here, we propose to test a mobile health (mHealth) version of PRISM, mPRISM. In a pilot randomized controlled trial, we will evaluate the feasibility, acceptability, and exploratory efficacy of mPRISM using a waitlist control design.

Official Title
-----------------
Pilot Trial Testing Mobile Health Psychosocial Intervention for Adolescents and Young Adults With Cancer

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: mPRISM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 12-25 years Diagnosis of new malignancy within 6 months of enrollment treated with chemotherapy and/or radiation therapy at Seattle Children's Hospital (SCH) Patient able to speak/read/write English or Spanish language Cognitively able to participate in mHealth psychosocial intervention and interactive interviews Exclusion Criteria: Patient refusal to participate (any age), or parental refusal to participate for patients less than 18 years of age Patients with diagnosis of malignancy >12 months Patients with relapsed, recurrent, or refractory disease Patient without chemotherapy and/or radiation therapy as part of cancer treatment (e.g., surgical resection only patients are not-eligible) Cognitively or physically unable to participate in mHealth psychosocial intervention and surveys

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized waitlist design: AYAs will be randomized 1:1 to psychosocial Usual Care (UC) or UC plus mPRISM. mPRISM will be provided to UC arm at 3-month follow-up.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mPRISM<br>The Experimental (mPRISM) arm will receive mPRISM upon completion of their baseline study surveys. | Behavioral: mPRISM<br>* PRISM is a brief, 1:1, skills-based resilience intervention delivered in-person by trained layperson coaches. PRISM's development was based on iterative research within the AYA oncology population, stress and coping theory, resilience theory, and successful cognitive-behavioral and mindfulness interventions. mPRISM is a digital version of the PRISM program with no in-person delivery. mPRISM includes coping skills modules: managing stress, goal-setting, cognitive reframing, and meaning-making.<br>|
| Other: Waitlist control<br>Usual Care (UC) available to both study arms consists of standard non-directed supportive care provided for all patients including an assigned social worker throughout cancer treatment. In a waitlist design, the UC arm will receive mPRISM upon completion of 3-month follow-up surveys. | Behavioral: mPRISM<br>* PRISM is a brief, 1:1, skills-based resilience intervention delivered in-person by trained layperson coaches. PRISM's development was based on iterative research within the AYA oncology population, stress and coping theory, resilience theory, and successful cognitive-behavioral and mindfulness interventions. mPRISM is a digital version of the PRISM program with no in-person delivery. mPRISM includes coping skills modules: managing stress, goal-setting, cognitive reframing, and meaning-making.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of intervention | The Acceptability of Intervention Measure (AIM) is a well-validated 4-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Scale ranges from 4 to 20; higher scores are better. | immediately post-intervention | 
| Appropriateness of intervention | The Intervention Appropriateness Measure (IAM) is a well-validated 4-item scale that measures the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and/or perceived fit of the innovation to address a particular issue or problem. Scale ranges from 4 to 20; higher scores are better. | immediately post-intervention | 
| Feasibility of intervention | The Feasibility of Intervention Measure (FIM) is a well-validated 4-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scale ranges from 4 to 20; higher scores are better. | immediately post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of intervention | The System Usability Scale (SUS) is a well-validated and widely used 10-item scale to evaluate the perceived usability of digital interventions. Items are rated on a 5-point Likert scale for a total score ranging from 0-100, and scores ≥70 considered adequate usability. | immediately post-intervention | 
| Change in health-related quality of life | The PedsQL 4.0 Generic and 3.0 Cancer Module include 50 items evaluating health-related quality of life (HRQOL) of AYAs with cancer. Queries assess physical, emotional, social, and school well-being, plus cancer-related pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance, and communication. Scores are linearly transformed to a 0-100 scale, with higher scores indicating better HRQOL. | immediately post-intervention, 3 months post-intervention | 
| Change in resilience | The CD-RISC is a well-validated and widely used 10-item instrument to measure inherent resiliency. Questions revolve around personal problem-solving and approaches to adversity. Scores range from 0-40, with higher scores indicating higher resilience. | immediately post-intervention, 3 months post-intervention | 
| Change in distress | This 6-item scale measures level of psychological distress experienced in the past month. The instrument strongly discriminates between community cases and non-cases of Diagnostic and Statistical Manual of Mental Disorder (DSM)-V psychiatric disorders such as serious emotional distress or serious mental illness. Scores range from 0-24, with higher scores indicating higher distress. | immediately post-intervention, 3 months post-intervention | 
| Change in anxiety and depression | 7 items assess symptoms of anxiety and depression, respectively, in patients with serious illness. It has been validated in AYAs with chronic illness and cancer survivors, with excellent reliability (α=0.83-0.82). Items are scored 0-3 (subscale range 0-21), with scores ≥8 categorized as borderline abnormal, and ≥11 categorized as abnormal. | immediately post-intervention, 3 months post-intervention | 
| Change in attention bias | The Attention Bias Questionnaire (ABQ) consists of nine items reflecting the subjective experience of attention bias towards threats, with two sub-scales: Engagement with Threat and Difficulty to Disengage from Threat. High ABQ scores are correlated with trait anxiety, social anxiety, PTSD, and depression. It has been validated in ages 18+, with high internal consistency (Cronbach's alpha=0.90). A total score is calculated as the mean of all nine items (range 0-4), with higher scores indicating greater attention bias. | immediately post-intervention, 3 months post-intervention | 
| Change in pain frequency | A single question will assess pain frequency (6- or 7-item Likert scale from not at all to daily). | immediately post-intervention, 3 months post-intervention | 
| Change in pain intensity | A single question will assess pain intensity (11-point Numeric Rating Scale, 0-10). | immediately post-intervention, 3 months post-intervention | 
| Change in pain interference | A single question will assess pain interference (11-point Numeric Rating Scale, 0-10). | immediately post-intervention, 3 months post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mobile health, Quality of life, Adolescent, Young Adult, Psychosocial factors