FOCUS for Pediatric Sickle Cell Disease and Cancer

Georgia State University

Status: Unknown

Conditions: Depressive Symptoms; Quality of Life; Coping Skills; Sickle Cell Disease; Pediatric Cancer

Treatments: Behavioral: FOCUS

Study type: Interventional

Funder types: Other

Identifiers

NCT04075877

FOCUS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

FOCUS

Experimental group

Description:

Participants will complete a baseline survey battery and learn about The Hero's Journey. Starting at hospital discharge for 10 days, they will do the following: 1) identify which stage of The Hero's Journey they are experiencing; 2) take a picture of something good and write a caption describing the picture and provide advice; and 3) take a picture of something difficult or challenging during the day and write a caption for the photo and provide advice. Daily text messages will remind participants to take the photographs, write the advice captions, upload both to the server, as well as to take a very brief daily survey. At the conclusion of day 10, participants will be asked to review their photos and captions and provide final advice in the form of a letter to other adolescents with SCD or cancer. Finally, they will complete a post-intervention battery.

Treatment:

Behavioral: FOCUS

Control

No Intervention group

Description:

In a 30-min visit (in person or virtual) with adolescents during hospitalizations, we will have participants complete a baseline survey battery. Daily text messages will remind participants to take a very brief daily survey. At the conclusion of day 10, participants will complete a post-intervention battery.