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Trial Title:
Resilience Mobile App for Teens and Young Adults With Cancer
NCT ID:
NCT05842902
Condition:
Cancer
Conditions: Keywords:
Mobile health
Quality of life
Adolescent
Young Adult
Psychosocial factors
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
mPRISM
Description:
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.
Arm group label:
Waitlist control
Arm group label:
mPRISM
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.
Criteria for 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
Gender:
All
Minimum age:
12 Years
Maximum age:
25 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Seattle Children's Hospital
Address:
City:
Seattle
Zip:
98105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nancy Lau, PhD
Phone:
206-884-8238
Email:
nancy.lau@seattlechildrens.org
Start date:
September 12, 2023
Completion date:
August 31, 2027
Lead sponsor:
Agency:
Seattle Children's Hospital
Agency class:
Other
Collaborator:
Agency:
University of Washington
Agency class:
Other
Source:
Seattle Children's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05842902
