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iCanCope With Sickle Cell Pain

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ClinicalTrials.gov Identifier: NCT03201874
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : November 6, 2020
Sponsor:
Collaborators:
The Hospital for Sick Children
Emory University
Connecticut Children's Medical Center
University of Mississippi Medical Center
University of Florida
Boston Medical Center
Northwestern University
Information provided by (Responsible Party):
Tonya Palermo, Seattle Children's Hospital

Tracking Information
First Submitted Date  ICMJE June 23, 2017
First Posted Date  ICMJE June 28, 2017
Last Update Posted Date November 6, 2020
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • Pain diary [ Time Frame: Change from baseline to 12 weeks and 26 weeks ]
    App diary using an 11-point numerical rating scale for pain intensity and Child Activity Limitations Inventory 9-items to measure activity limitations for 7 days
  • Adaptive coping [ Time Frame: Change from baseline to 12 weeks and 26 weeks ]
    Coping Strategies Questionnaire for Sickle Cell Disease
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
  • Pain diary [ Time Frame: 2 months after starting treatment ]
    App diary using an 11-point numerical rating scale for pain intensity and Child Activity Limitations Inventory 9-items to measure activity limitations for 7 days
  • Adaptive coping [ Time Frame: 2 months after starting treatment ]
    Coping Strategies Questionnaire for Sickle Cell Disease
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • Treatment acceptability [ Time Frame: 2 months after starting treatment ]
    Treatment Evaluation Inventory
  • Physical and emotional functioning [ Time Frame: Change from baseline to 12 weeks and 26 weeks ]
    Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile: depressive symptoms, anxiety, mobility, pain interference, fatigue, peer relationships
  • Patient Global Impression of Change [ Time Frame: 12 weeks and 26 weeks ]
    Global rating for improvement in pain and functioning
  • Parent protectiveness [ Time Frame: Change from baseline to 12 weeks and 26 weeks ]
    Adult Responses to Children's Symptoms
  • Health services utilization [ Time Frame: Change from baseline to 26 weeks ]
    Client Services Receipt Inventory adapted for sickle cell disease
  • Parent psychological distress [ Time Frame: Change from baseline to 12 weeks and 26 weeks ]
    Symptom Checklist 90
  • Child physical and emotional functioning [ Time Frame: Change from baseline to 12 weeks and 26 weeks ]
    Bath Adolescent Pain Questionnaire - Parent version assesses social functioning (score range: 0-36), physical functioning (0-36), depression (0-24), general anxiety (0-28), pain specific anxiety (0-28), family functioning (0-48) and development (0-44). A higher score indicates more impaired functioning for all subscales.
  • Unwanted treatment effects [ Time Frame: 12 weeks and 26 weeks ]
    Self report of adverse events during treatment. The number of participants with unwanted treatment effects will be reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
  • Quality of life [ Time Frame: 6 month follow up ]
    The Pediatric Quality of Life Inventory - Sickle Cell Disease version assesses impact of SCD on child and family
  • Treatment acceptability [ Time Frame: 2 months after starting treatment ]
    Treatment Evaluation Inventory
  • Emotional distress [ Time Frame: 2 months after starting treatment ]
    Patient-reported Outcomes Measurement Information System anxiety and depression scales
  • Patient Global Impression of Change [ Time Frame: 2 months after starting treatment ]
    Global rating for improvement in pain and functioning
  • Parent protectiveness [ Time Frame: 2 months after starting treatment ]
    Parent protective behavior on the Adult Responses to Child Symptoms
  • Health services utilization [ Time Frame: 6 month follow up ]
    Client Services Receipt Inventory adapted for sickle cell disease
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE iCanCope With Sickle Cell Pain
Official Title  ICMJE iCanCope With Sickle Cell Disease: A Mobile Pain Management Intervention for Adolescents
Brief Summary The project will test a tailored web and smartphone-based application (iCanCope with SCD) to improve pain self-management and functioning in youth (aged 12-18) with sickle cell disease. The program will include goal setting, peer-based social support, and pain self-management training. The investigators will determine initial program effectiveness through a pilot three-site randomized controlled trial in 160 youth randomized to treatment compared to attention control.
Detailed Description Cognitive-behavioral therapies (CBT) that promote pain self-management can lead to symptom reduction, improved quality of life, and decreased healthcare use. However, most people with SCD do not receive CBT-based treatment due to barriers such as poor accessibility, limited availability of professionals, and high costs. First, the investigators plan to apply a user-centered design approach to develop and refine the iCanCope with SCD program. Second, program feasibility and initial program effectiveness will be determined through a pilot three-site randomized controlled trial. The investigators will determine study accrual and dropout rates as well as levels of patient acceptability and engagement. Preliminary effectiveness will be determined in youth receiving treatment compared to attention control on a range of physical, behavioral, and psychosocial outcomes assessed at post-treatment and 6-month follow-up. Third, moderators and mediators of treatment effect will be tested by examining whether differences in self-efficacy and patient activation predict changes in pain and functioning. These results will enable a future full-scale randomized controlled trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE
  • Behavioral: Pain self-management
    The program is designed to enhance self-efficacy. The app will guide youth in setting structured and personalized goals aimed at improving their pain and functioning. The pain self-management skills will include personalized CBT-based coping skills including deep breathing, relaxation, and cognitive skills (e.g., staying positive). The app will provide in-the-moment access to pain coping strategies to promote positive changes in mood, behavior, and pain.
  • Behavioral: Education
    Education about sickle cell disease to increase disease knowledge
Study Arms  ICMJE
  • Active Comparator: Education Control
    In addition to standard medical care, youth in the education control group will be provided with access to a self-guided education study website, which will contain static education about SCD (no self-management skills, goal-setting, or social support content) to access over 8-weeks.
    Intervention: Behavioral: Education
  • Experimental: Pain Self-Management Intervention
    In addition to standard medical SCD care, youth in the pain self-management intervention group will receive the iCanCope with SCD mobile intervention including goal-setting, peer social support, and pain self-management skills over a period of 8 weeks.
    Interventions:
    • Behavioral: Pain self-management
    • Behavioral: Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2017)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • aged between 12-18 years
  • diagnosed with any type of SCD
  • able to speak and read English
  • score at least 4 (indicating some days with pain interference over the past month) on the Sickle Cell Pain Burden Interview
  • willing and able to complete online measures

Exclusion Criteria:

  • significant cognitive limitations that would impair their ability to use and understand the iCanCope with SCD program, as per their healthcare provider or parent
  • have previously received more than 4 sessions of outpatient psychological therapy for pain management in the 6 months prior to the time of screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tonya M Palermo, PhD 206-884-4208 tonya.palermo@seattlechildrens.org
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03201874
Other Study ID Numbers  ICMJE R01HD086978( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
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  ICMJE
Plan to Share IPD: Undecided
Responsible Party Tonya Palermo, Seattle Children's Hospital
Study Sponsor  ICMJE Seattle Children's Hospital
Collaborators  ICMJE
  • The Hospital for Sick Children
  • Emory University
  • Connecticut Children's Medical Center
  • University of Mississippi Medical Center
  • University of Florida
  • Boston Medical Center
  • Northwestern University
Investigators  ICMJE
Principal Investigator: Tonya M Palermo, PhD Seattle Children's Hospital
PRS Account Seattle Children's Hospital
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP