Resilience Mobile App for Teens and Young Adults With Cancer

Seattle Children's Hospital80 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cancer

Interventions

mPRISMBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 25 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 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

Locations (1)

Seattle Children's Hospital

Seattle, Washington, United States

RECRUITING

Outcomes

Primary Outcomes

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-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.

Time frame: 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.

Time frame: immediately post-intervention

Secondary Outcomes

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-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.

Central Contacts

Nancy Lau, PhD

CONTACT

206-884-0569 nancy.lau@seattlechildrens.org

Data from ClinicalTrials.gov

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