NCT04075877

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 3, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 10, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

November 13, 2020

Status Verified

January 1, 2020

Enrollment Period

1.6 years

First QC Date

July 9, 2019

Last Update Submit

November 10, 2020

Conditions

Pediatric CancerSickle Cell DiseaseQuality of LifeDepressive SymptomsCoping Skills

Keywords

Pediatric cancerPediatric Sickle Cell DiseaseQuality of LifeRandomized Controlled TrialInterventionPhotographyNarrative PsychologyAdolescence

Outcome Measures

Primary Outcomes (8)

  • Life Satisfaction

    PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Item Bank v1.0 - Life Satisfaction - Short Form 8a; Forrest, C. B., Devine, J., Bevans, K. B., Becker, B. D., Carle, A. C., Teneralli, R. E., … Ravens-Sieberer, U. (2018). Development and psychometric evaluation of the PROMIS Pediatric Life Satisfaction item banks, child-report, and parent-proxy editions. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 27(1), 217-234. doi:10.1007/s11136-017-1681-7; Scores range from 8-40, with higher scores representing more life satisfaction

    Change from baseline to post-intervention at 10 days

  • Depression

    PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Item Bank v2.0 - Depressive Symptoms - Short Form 8a; Irwin, D. E., Stucky, B., Langer, M. M., Thissen, D., Dewitt, E. M., Lai, J. S., … DeWalt, D. A. (2010). An item response analysis of the pediatric PROMIS anxiety and depressive symptoms scales. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 19(4), 595-607. doi:10.1007/s11136-010-9619-3; Scores range from 8-40, with higher scores representing more depression

    Change from baseline to post-intervention at 10 days

  • Anxiety

    PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Item Bank v2.0 - Anxiety Symptoms - Short Form 8a; Irwin, D. E., Stucky, B., Langer, M. M., Thissen, D., Dewitt, E. M., Lai, J. S., … DeWalt, D. A. (2010). An item response analysis of the pediatric PROMIS anxiety and depressive symptoms scales. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 19(4), 595-607. doi:10.1007/s11136-010-9619-3; Scores range from 8-40, with higher scores representing more anxiety

    Change from baseline to post-intervention at 10 days

  • Meaning and Purpose

    PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Item Bank v2.0 - Meaning and Purpose - Short Form 8a; Christopher B Forrest, Katherine B Bevans, Ania Filus, Janine Devine, Brandon D Becker, Adam C Carle, Rachel E Teneralli, JeanHee Moon, Ulrike Ravens-Sieberer, Assessing Children's Eudaimonic Well-Being: The PROMIS Pediatric Meaning and Purpose Item Banks, Journal of Pediatric Psychology, jsz046, https://doi.org/10.1093/jpepsy/jsz046; Scores range from 8-40, with higher scores representing more meaning and purpose

    Change from baseline to post-intervention at 10 days

  • Positive Affect

    PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Item Bank v2.0 - Positive Affect - Short Form 8a; Forrest, C. B., Ravens-Sieberer, U., Devine, J., Becker, B. D., Teneralli, R., Moon, J., … Bevans, K. B. (2018). Development and Evaluation of the PROMIS® Pediatric Positive Affect Item Bank, Child-Report and Parent-Proxy Editions. Journal of happiness studies, 19(3), 699-718. doi:10.1007/s10902-016-9843-9; Scores range from 8-40, with higher scores representing more positive affect

    Change from baseline to post-intervention at 10 days

  • Functional Disability

    Functional Disability Inventory (FDI)

    Change from baseline to post-intervention at 10 days

  • Mindfulness

    Child and Adolescence Mindfulness Measure (CAMM)

    Change from baseline to post-intervention at 10 days

  • Approach to Dealing with Adversity

    Shift and Persist Measure

    Change from baseline to post-intervention at 10 days

Secondary Outcomes (2)

  • Resilience

    Change from baseline to post-intervention at 10 days

  • Social Connectedness

    Change from baseline to post-intervention at 10 days

Other Outcomes (2)

  • Executive Functioning

    Change from baseline to post-intervention at 10 days

  • Prosocial Behavior

    Change from baseline to post-intervention at 10 days

Study Arms (2)

FOCUS

EXPERIMENTAL

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.

Behavioral: FOCUS

Control

NO INTERVENTION

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

FOCUSBEHAVIORAL

See prior section.

FOCUS

Eligibility Criteria

Age12 Years - 18 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \) diagnosis of sickle cell disease, any hemoglobin type or diagnosis of leukemia, lymphoma, or solid tumor
  • \) inpatient at CHOA
  • \) 12-18 years of age
  • \) English speaking
  • \) owns a smartphone with camera.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Georgia State University

Atlanta, Georgia, 30302, United States

NOT YET RECRUITING

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

RECRUITING

MeSH Terms

Conditions

NeoplasmsAnemia, Sickle CellDepression

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavioral SymptomsBehavior

Study Officials

  • Lindsey L Cohen, PhD

    Georgia State University

    PRINCIPAL INVESTIGATOR

  • Laura G McKee

    Georgia State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura G McKee, PhD

CONTACT

802-5789075lmckee1@gsu.edu

Lindsey L Cohen, PhD

CONTACT

404-413-6263llcohen@gsu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The care provider and the outcomes assessor will be blind to participants' study assignments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 9, 2019

First Posted

September 3, 2019

Study Start

January 10, 2020

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

November 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)