FOCUS for Pediatric Sickle Cell Disease and Cancer (FOCUS)

• ClinicalTrials.gov Identifier: NCT04075877
• Recruitment Status: Unknown
• First Posted: September 3, 2019
• Last Update Posted: November 13, 2020
• Sponsor: Georgia State University
• Information provided by (Responsible Party): Laura Mckee, Georgia State University

Tracking Information

• First Submitted Date: July 9, 2019
• First Posted Date: September 3, 2019
• Last Update Posted Date: November 13, 2020
• Actual Study Start Date: January 10, 2020
• Estimated Primary Completion Date: July 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 30, 2019)

• Life Satisfaction [ Time Frame: Change from baseline to post-intervention at 10 days ]
  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
• Depression [ Time Frame: Change from baseline to post-intervention at 10 days ]
  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
• Anxiety [ Time Frame: Change from baseline to post-intervention at 10 days ]
  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
• Meaning and Purpose [ Time Frame: Change from baseline to post-intervention at 10 days ]
  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
• Positive Affect [ Time Frame: Change from baseline to post-intervention at 10 days ]
  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
• Functional Disability [ Time Frame: Change from baseline to post-intervention at 10 days ]
  Functional Disability Inventory (FDI)
• Mindfulness [ Time Frame: Change from baseline to post-intervention at 10 days ]
  Child and Adolescence Mindfulness Measure (CAMM)
• Approach to Dealing with Adversity [ Time Frame: Change from baseline to post-intervention at 10 days ]
  Shift and Persist Measure

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 30, 2019)

• Resilience [ Time Frame: Change from baseline to post-intervention at 10 days ]
  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
• Social Connectedness [ Time Frame: Change from baseline to post-intervention at 10 days ]
  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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: August 30, 2019)

• Executive Functioning [ Time Frame: Change from baseline to post-intervention at 10 days ]
  PROMIS Cognitive Function
• Prosocial Behavior [ Time Frame: Change from baseline to post-intervention at 10 days ]
  Self-Report of Aggression and Social Behavior Measure, Prosocial Behavior subscale

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: FOCUS for Pediatric Sickle Cell Disease and Cancer
• Official Title: FOCUS: Feasibility, Acceptability, and Pilot of an Intervention to Improve Functioning in Adolescents With Sickle Cell Disease and Cancer
• 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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized controlled trial

Masking: Double (Care Provider, Outcomes Assessor)
Masking Description:

The care provider and the outcomes assessor will be blind to participants' study assignments.

Primary Purpose: Treatment

Condition

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

Intervention

Behavioral: FOCUS

See prior section.

Study 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.

  Intervention: Behavioral: FOCUS
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 30, 2019): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 30, 2021
• Estimated Primary Completion Date: July 30, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes

• Ages: 12 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04075877
• Other Study ID Numbers: FOCUS
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Laura Mckee, Georgia State University
• Original Responsible Party: Same as current
• Current Study Sponsor: Georgia State University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lindsey L Cohen, PhD; Georgia State University
• Principal Investigator: Laura G McKee; Georgia State University

• PRS Account: Georgia State University
• Verification Date: January 2020