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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 : May 1, 2018
Sponsor:
Collaborators:
The Hospital for Sick Children
Emory University
Connecticut Children's Medical Center
Information provided by (Responsible Party):
Tonya Palermo, Seattle Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Behavioral: Pain self-management Behavioral: Education Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: iCanCope With Sickle Cell Disease: A Mobile Pain Management Intervention for Adolescents
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Education
Education about sickle cell disease to increase disease knowledge

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.
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




Primary Outcome Measures :
  1. 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

  2. Adaptive coping [ Time Frame: 2 months after starting treatment ]
    Coping Strategies Questionnaire for Sickle Cell Disease


Secondary Outcome Measures :
  1. 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

  2. Treatment acceptability [ Time Frame: 2 months after starting treatment ]
    Treatment Evaluation Inventory

  3. Emotional distress [ Time Frame: 2 months after starting treatment ]
    Patient-reported Outcomes Measurement Information System anxiety and depression scales

  4. Patient Global Impression of Change [ Time Frame: 2 months after starting treatment ]
    Global rating for improvement in pain and functioning

  5. Parent protectiveness [ Time Frame: 2 months after starting treatment ]
    Parent protective behavior on the Adult Responses to Child Symptoms

  6. Health services utilization [ Time Frame: 6 month follow up ]
    Client Services Receipt Inventory adapted for sickle cell disease



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201874


Contacts
Contact: Tonya M Palermo, PhD 206-884-4208 tonya.palermo@seattlechildrens.org

Locations
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: William Zempsky, MD       wzempsk@connecticutchildrens.org   
Principal Investigator: William Zempsky, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Carlton Dampier, MD       cdampie@emory.edu   
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Tonya Palermo, PhD         
Principal Investigator: Tonya M Palermo, PhD         
Sub-Investigator: Matthew Giefer, MD         
Sub-Investigator: Gary Walco, PhD         
Sub-Investigator: Anne Stevens, MD         
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada
Contact: Jennifer Stinson, PhD       jennifer.stinson@sickkids.ca   
Sponsors and Collaborators
Seattle Children's Hospital
The Hospital for Sick Children
Emory University
Connecticut Children's Medical Center
Investigators
Principal Investigator: Tonya M Palermo, PhD Seattle Children's Hospital

Responsible Party: Tonya Palermo, Professor, Anesthesiology and Pain Medicine, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03201874     History of Changes
Other Study ID Numbers: R01HD086978 ( U.S. NIH Grant/Contract )
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn