Resilience Mobile App for Teens and Young Adults With Cancer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842902
• Other study ID #: STUDY00004006
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: February 2024
• Source: Seattle Children's Hospital
• Contact: Nancy Lau, PhD
• Phone: 206-884-0569
• Email: nancy.lau[@]seattlechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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 (a=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