Recruiting

FOCUS

Sponsor:

Georgia State University

Code:

NCT04075877

Conditions

Pediatric Cancer

Sickle Cell Disease

Quality of Life

Depressive Symptoms

Coping Skills

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

FOCUS

Study Details

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.

Conditions

Pediatric Cancer

Sickle Cell Disease

Quality of Life

Depressive Symptoms

Coping Skills

Study ID

NCT04075877

Start date

Jan 10, 2020

Status verified date

Jan, 2020

Completion date

Jul 30, 2021

Anticipated

Primary completion date

Jul 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FOCUS

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.

no intervention: Control

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.

Interventions

FOCUS

See prior section.

Primary outcome measure

  • Life Satisfaction [ Time Frame: Change from baseline to post-intervention at 10 days ]
  • Depression [ Time Frame: Change from baseline to post-intervention at 10 days ]
  • Anxiety [ Time Frame: Change from baseline to post-intervention at 10 days ]
  • Meaning and Purpose [ Time Frame: Change from baseline to post-intervention at 10 days ]
  • Positive Affect [ Time Frame: Change from baseline to post-intervention at 10 days ]
  • Functional Disability [ Time Frame: Change from baseline to post-intervention at 10 days ]
  • Mindfulness [ Time Frame: Change from baseline to post-intervention at 10 days ]
  • Approach to Dealing with Adversity [ Time Frame: Change from baseline to post-intervention at 10 days ]

Central Contacts and Locations

Central contacts

Laura G McKee, PhD

802-5789075lmckee1@gsu.edu

Lindsey L Cohen, PhD

404-413-6263llcohen@gsu.edu

Locations

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30342

Principal Investigator:

Laura G McKee, PhD

More Information

Sponsor

Georgia State University

Last update posted

Nov 13, 2020

Last verified

Jan, 2020

Keywords

  • Pediatric cancer
  • Pediatric Sickle Cell Disease
  • Quality of Life
  • Randomized Controlled Trial
  • Intervention
  • Photography
  • Narrative Psychology
  • Adolescence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgia State University on 2020-11-13.