Resilience Mobile App for Teens and Young Adults With Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: mPRISM The Experimental (mPRISM) arm will receive mPRISM upon completion of their baseline study surveys. |
Behavioral: mPRISM
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.
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| Other: Waitlist control 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
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.
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Outcome Measures
Primary Outcome Measures
- Acceptability of intervention [immediately post-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.
- Appropriateness of intervention [immediately post-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.
- Feasibility of intervention [immediately post-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.
Secondary Outcome Measures
- Usability of intervention [immediately post-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.
- Change in health-related quality of life [immediately post-intervention, 3 months post-intervention]
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.
- Change in resilience [immediately post-intervention, 3 months post-intervention]
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.
- Change in distress [immediately post-intervention, 3 months post-intervention]
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.
- Change in anxiety and depression [immediately post-intervention, 3 months post-intervention]
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.
- Change in attention bias [immediately post-intervention, 3 months post-intervention]
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.
- Change in pain frequency [immediately post-intervention, 3 months post-intervention]
A single question will assess pain frequency (6- or 7-item Likert scale from "not at all" to "daily").
- Change in pain intensity [immediately post-intervention, 3 months post-intervention]
A single question will assess pain intensity (11-point Numeric Rating Scale, 0-10).
- Change in pain interference [immediately post-intervention, 3 months post-intervention]
A single question will assess pain interference (11-point Numeric Rating Scale, 0-10).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 12-25 years
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Diagnosis of new malignancy within 6 months of enrollment treated with chemotherapy and/or radiation therapy at Seattle Children's Hospital (SCH)
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Patient able to speak/read/write English or Spanish language
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Cognitively able to participate in mHealth psychosocial intervention and interactive interviews
Exclusion Criteria:
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Patient refusal to participate (any age), or parental refusal to participate for patients less than 18 years of age
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Patients with diagnosis of malignancy >12 months
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Patients with relapsed, recurrent, or refractory disease
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Patient without chemotherapy and/or radiation therapy as part of cancer treatment (e.g., surgical resection only patients are not-eligible)
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Cognitively or physically unable to participate in mHealth psychosocial intervention and surveys
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Seattle Children's Hospital
- University of Washington
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00004006