November, 11 2019

FOCUS: Feasibility, Acceptability, and Pilot of an Intervention to Improve Functioning in Adolescents With Sickle Cell Disease and Cancer

Locations

2 United States sites

Age

12 to 18 Years

Phase

N/A

About the study

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.

Study Type

Interventional

Phase

N/A

Age

12 to 18 Years

Gender

All

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.

Interventions

  • Behavioral

Outcome measures

  • Anxiety
  • Approach to Dealing with Adversity
  • Depression
  • Functional Disability
  • Life Satisfaction
  • Meaning and Purpose
  • Mindfulness
  • Positive Affect

Location

  • Georgia State University, Atlanta, Georgia, United States, 30302 [Not yet recruiting]
  • Children's Healthcare of Atlanta, Atlanta, Georgia, United States, 30342 [Not yet recruiting]

Contact Research Team

  • Lindsey L Cohen, PhD
    404-413-6263
  • Laura G McKee, PhD
    802-5789075

More info

View on ClinicalTrials
Site is under construction