Resilience Mobile App for Teens and Young Adults With Cancer

Seattle Children's Healthcare System

Status: Enrolling

Conditions: Cancer

Treatments: Behavioral: mPRISM

Study type: Interventional

Funder types: Other

Identifiers

NCT05842902

STUDY00004006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 12 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

mPRISM

Experimental group

Description:

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

Treatment:

Behavioral: mPRISM

Waitlist control

Other group

Description:

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.

Treatment:

Behavioral: mPRISM