Resilience Mobile App for Teens and Young Adults With Cancer
ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-25
SponsorSeattle Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 12-25 years
Diagnosis of new malignancy within 12 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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
mPRISM
BehavioralPRISM 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: mPRISMExperimental treatment 1 intervention
Group B: Waitlist controlOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
immediately post-intervention2
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.
Time frame
immediately post-intervention3
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.
Time frame
immediately post-interventionSecondary outcomes
1
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.
Time frame
immediately post-intervention2
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.
Time frame
immediately post-intervention, 3 months post-intervention3
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.
Time frame
immediately post-intervention, 3 months post-intervention4
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.
Time frame
immediately post-intervention, 3 months post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Seattle Children's Hospital
Lead sponsor
University of Washington
Collaborator
Source ClinicalTrials.gov