FOCUS for Pediatric Sickle Cell Disease and Cancer

Quality of Life Clinical Trial

— FOCUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04075877
• Other study ID #: FOCUS
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: January 2020
• Source: Georgia State University
• Contact: Laura G McKee, PhD
• Phone: 802-5789075
• Email: lmckee1[@]gsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Coping Skills
• Depression
• Depressive Symptoms
• Pediatric Cancer
• Quality of Life
• Sickle Cell Disease

Intervention

Behavioral:
• FOCUS
See prior section.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Georgia State University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Georgia State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Executive Functioning	PROMIS Cognitive Function	Change from baseline to post-intervention at 10 days
Other	Prosocial Behavior	Self-Report of Aggression and Social Behavior Measure, Prosocial Behavior subscale	Change from baseline to post-intervention at 10 days
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Functional Disability	Functional Disability Inventory (FDI)	Change from baseline to post-intervention at 10 days
Primary	Mindfulness	Child and Adolescence Mindfulness Measure (CAMM)	Change from baseline to post-intervention at 10 days
Primary	Approach to Dealing with Adversity	Shift and Persist Measure	Change from baseline to post-intervention at 10 days
Secondary	Resilience	Conner-Davidson Resilience Scale - 10; Davidson, J. R. T. & Connor, K. M. Connor-Davidson Resilience Scale (CD-RISC) Manual. Unpublished. 06-01-2018 and partly accessible at www.cd-risc.com.Total Score Range 0-40, with higher scores reflecting higher resilience	Change from baseline to post-intervention at 10 days
Secondary	Social Connectedness	Social Connectedness and Social Assurance Scale; Lee, R. M., & Robbins, S. B. (1995). Measuring belongingness: The social connectedness and the social assurance scales. Journal of Counseling Psychology, 42, 232-241; Using the Social Connectedness Factor only; 8 items; Range 8-48, with higher scores reflecting higher levels of social connectedness and belongingness	Change from baseline to post-intervention at 10 days