A Pilot RCT of the PRISM Intervention for AYAs With Cancer

The experience of serious illness among adolescents and young adults (AYAs) is unique because
they face distinctive developmental challenges, transitions, and choices related to
education, employment, identity, relationships and family. Age-specific interventions are
needed to promote positive resources and outcomes. Resilience, for example, is a construct
describing an individual's capacity to maintain psychological and/or physical well-being in
the face of stress, and is a good candidate to buffer the negative effects of stress. While
few studies have described positive outcomes in AYA patients with chronic disease, and fewer
still have suggested mechanisms to promote resilience, evidence suggests promoting
"resilience-resources" (e.g., stress-management and goal setting skills, meaning-making and
positive-reframing of negative experiences), as a means to manage stress may be valuable.

We have previously described models and factors of resilience among AYAs with cancer as well
as parents of children with cancer, and demonstrated that self-perceptions of resilience are
strongly associated with outcomes. Through iterative pilot testing, we have successfully
developed a novel, patient-centered resilience-based intervention, the "Promoting Resilience
in Stress Management" (PRISM) intervention.

The overall goal of the PRISM intervention is to improve AYA self-perceived resilience,
thereby reducing AYA distress, improving quality of life, and minimizing risky health
behaviors. The brief format involves 4, 50-minute, one-on-one sessions approximately 2 weeks
apart, plus a 5th, optional, family-inclusive session 2-4 weeks following session #4. These
are complimented with age-specific handouts describing the skills and opportunities to
practice them, as well as monthly "booster" sessions. Specifically, the intervention
incorporates four primary skills: 1) stress management/mindfulness; 2) goal-setting; 3)
cognitive restructuring; and, 4) meaning-making/benefit finding.

Enrolled patients will be between 13 and 25 years-old with at least a 2 week history of new
or recurrent malignancy. They will be randomized to receive the PRISM intervention or
standard psychosocial supportive care. Patients in both groups will be invited to complete
quantitative surveys at the time of enrollment and then 2-, 4-, 6-, and 12-months later.
Participants will be compensated for their time.

The primary outcome of the study is self-perceived resilience, as measured by the
Connor-Davidson Resilience Score, at 6-months post-enrollment. Secondary outcomes will assess
resilience scores at 4, 6, and 12 months, as well as self-efficacy, anxiety, depression,
benefit-finding, quality of life, goal-setting skills, and health behaviors at 6 and 12
months.

The study is anticipated to accrue a total of 100 patients over 2 years.

Inclusion Criteria:

1. Age 13-25 years

1. Patient aged 13-17 years: has signed informed assent and their parent/legal
guardian has signed informed consent for study participation.

2. Patient aged 18-25 years: has signed informed consent for study participation.

2. Diagnosis of malignancy treated with chemotherapy and/or radiation therapy at Seattle
Childrens Hospital (SCH)

1. New diagnosis of malignancy within 1-10 weeks of enrollment

2. New diagnosis of recurrent disease (after initial remission) within 1-10 weeks of
enrollment

3. Ability to speak and read English language

4. Cognitively able to participate in interactive interviews

Exclusion Criteria:

1. Patient refusal to participate (any age), or parental refusal to participate for
patients less than 18 years of age

2. Cognitively or physically unable to participate in interactive interview

3. Unable to speak and read English language

4. Patient without chemotherapy and/or radiation therapy as part of cancer treatment
(e.g., surgical resection only patients are not-eligible).