Resilience Mobile App for Teens and Young Adults With Cancer

NCT05842902 | Recruiting

• 1 other identifier: STUDY00004006
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Mobile health; Quality of life; Adolescent; Young Adult; Psychosocial factors

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Usability of intervention

  immediately post-intervention

• Change in health-related quality of life

  immediately post-intervention, 3 months post-intervention

• Change in resilience

  immediately post-intervention, 3 months post-intervention

• Change in distress

  immediately post-intervention, 3 months post-intervention

• Change in anxiety and depression

  immediately post-intervention, 3 months post-intervention

Study Arms (2)

mPRISM

EXPERIMENTAL

The Experimental (mPRISM) arm will receive mPRISM upon completion of their baseline study surveys.

Behavioral: mPRISM

Waitlist control

OTHER

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

Interventions

mPRISM BEHAVIORAL

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.

Waitlist control; mPRISM

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• University of Washington: collaborator

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Related Publications (1)

• Lau N, Palermo TM, Zhou C, Badillo I, Hong S, Aalfs H, Yi-Frazier JP, McCauley E, Chow EJ, Weiner BJ, Ben-Zeev D, Rosenberg AR. Mobile App Promoting Resilience in Stress Management for Adolescents and Young Adults With Cancer: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Jul 30;13:e57950. doi: 10.2196/57950.

  PMID: 39079108 DERIVED

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Nancy Lau, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 6, 2023
• Study Start: September 12, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)