Clinical trial NCT05842902: Resilience Mobile App for Teens and Young Adults With Cancer
Official title: Pilot Trial Testing Mobile Health Psychosocial Intervention for Adolescents and Young Adults With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Mobile health
Quality of life
Adolescent
Young Adult
Psychosocial factors
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2023-05-06
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of intervention
timeFrame: immediately post-intervention
measure: Appropriateness of intervention
timeFrame: immediately post-intervention
measure: Feasibility of intervention
timeFrame: immediately post-intervention
Secondary outcomes:
measure: Usability of intervention
timeFrame: immediately post-intervention
measure: Change in health-related quality of life
timeFrame: immediately post-intervention, 3 months post-intervention
measure: Change in resilience
timeFrame: immediately post-intervention, 3 months post-intervention
measure: Change in distress
timeFrame: immediately post-intervention, 3 months post-intervention
measure: Change in anxiety and depression
timeFrame: immediately post-intervention, 3 months post-intervention
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
References: