Clinical trial NCT04075877: FOCUS for Pediatric Sickle Cell Disease and Cancer
Official title: FOCUS: Feasibility, Acceptability, and Pilot of an Intervention to Improve Functioning in Adolescents With Sickle Cell Disease and Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Cancer
Sickle Cell Disease
Quality of Life
Depressive Symptoms
Coping Skills
Keywords: Pediatric cancer
Pediatric Sickle Cell Disease
Quality of Life
Randomized Controlled Trial
Intervention
Photography
Narrative Psychology
Adolescence
Lead sponsor: Georgia State University
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Aim. Pilot FOCUS. A pilot randomized controlled trial will compare FOCUS to standard care. Investigators will randomize a total of 60 12- to 18-year-old patients to either FOCUS intervention (n=15 with SCD; n=15 with cancer) or treatment as usual (n=15 with SCD; n=15 with cancer). Randomization will be stratified to match patients based on age, sex, and medical condition (SCD type, cancer type). FOCUS participants will engage in the intervention and complete measures for 10 days post hospital discharge. Control participants will complete similar measures but not receive the intervention. Mixed qualitative and quantitative measures of feasibility, acceptability, and preliminary outcomes will be conducted to evaluate both the intervention and study procedures.

Detailed description: Sickle cell disease (SCD) and cancer are medical conditions in youth that are associated with psychosocial problems including anxiety and depressive symptoms and impaired health-related quality of life. Both SCD and cancer can require a number of treatments and hospitalizations, which negatively impact family relationships, peer functioning, and other life domains. In addition, both conditions and treatments can involve a range of symptoms or side effects (e.g., pain, fatigue, nausea) that interfere with daily life. In other words, patients with SCD and cancer are responsible for gradually learning to manage and live with challenges associated with their medical condition. As such, recent efforts focus on providing psychological interventions to support self-management as an adjunct to standard medical care.

Children and adolescents with SCD and cancer may have limited access to skilled psychologists or may not be able to attend frequent in-person intervention visits to acquire skills to support psychosocial functioning. A critical barrier to helping adolescents with SCD and cancer is that there are few portable interventions that provide assistance outside of the hospital environment.

The goal of this proposal is to pilot test FOCUS (Framing Opportunities and Challenges Using Stories), an innovative and portable intervention designed to improve the psychosocial functioning of adolescents with medical conditions. The intervention involves taking and captioning purposeful photographs that align with The Hero's Journey, a guiding narrative template that chronicles a hero's passage through life's adventures and challenges, culminating in individual strength and transformation (Campbell, 1968). Preliminary data evaluating components of FOCUS revealed significant improvements in mood among healthy adolescents and young adults. Data suggest that reflecting on positive and negative daily events (e.g., via a photograph) and writing about the experiences have profound positive effects on a range of outcomes (e.g., grit, gratitude, functioning). In addition, the investigators intend to share the participants' photographs, stories, and advice on a website for other adolescents with SCD or cancer. Data indicate that prosocial behavior (e.g., providing advice to peers) and social connectedness have a number of positive outcomes. The central prediction is that FOCUS will be acceptable and feasible to deliver and that pilot data will reveal improvements in participants' psychosocial health. Achieving these aims will provide the foundational data needed for federal grant applications to evaluate FOCUS with a larger pediatric sample and other patient populations, powered to identify outcomes and mechanisms of change.

Aim. Pilot FOCUS. A pilot randomized controlled trial will compare FOCUS to standard care. Investigators will randomize a total of 60 12- to 18-year-old patients to either FOCUS intervention (n=15 with SCD; n=15 with cancer) or treatment as usual (n=15 with SCD; n=15 with cancer). Randomization will be stratified to match patients based on age, sex, and medical condition (SCD type, cancer type). FOCUS participants will engage in the intervention and complete measures for 10 days post hospital discharge. Control participants will complete similar measures but not receive the intervention. Mixed qualitative and quantitative measures of feasibility, acceptability, and preliminary outcomes will be conducted to evaluate both the intervention and study procedures.

Eligibility criteria: Inclusion Criteria:

* 1) diagnosis of sickle cell disease, any hemoglobin type or diagnosis of leukemia, lymphoma, or solid tumor
* 2) inpatient at CHOA
* 3) 12-18 years of age
* 4) English speaking
* 5) owns a smartphone with camera.

Exclusion Criteria:

* 1) report of active psychosis or active suicidal ideation in the adolescents
* 2) significant documented developmental delay, autism spectrum disorder, or significant intellectual impairment, as these comorbidities may confound the study aims by impacting the dependent measures.

Primary outcomes:
measure: Life Satisfaction
timeFrame: Change from baseline to post-intervention at 10 days
measure: Depression
timeFrame: Change from baseline to post-intervention at 10 days
measure: Anxiety
timeFrame: Change from baseline to post-intervention at 10 days
measure: Meaning and Purpose
timeFrame: Change from baseline to post-intervention at 10 days
measure: Positive Affect
timeFrame: Change from baseline to post-intervention at 10 days
measure: Functional Disability
timeFrame: Change from baseline to post-intervention at 10 days
measure: Mindfulness
timeFrame: Change from baseline to post-intervention at 10 days
measure: Approach to Dealing with Adversity
timeFrame: Change from baseline to post-intervention at 10 days
Secondary outcomes:
measure: Resilience
timeFrame: Change from baseline to post-intervention at 10 days
measure: Social Connectedness
timeFrame: Change from baseline to post-intervention at 10 days
Other outcomes:
measure: Executive Functioning
timeFrame: Change from baseline to post-intervention at 10 days
measure: Prosocial Behavior
timeFrame: Change from baseline to post-intervention at 10 days
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Georgia State University
name: Lindsey L Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgia State University
name: Laura G McKee
role: PRINCIPAL_INVESTIGATOR
References: