iCanCope With Sickle Cell Pain

• Sponsor: Seattle Children's Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03201874
• Collaborator: The Hospital for Sick Children (Other), Emory University (Other), Connecticut Children's Medical Center (Other), University of Mississippi Medical Center (Other), University of Florida (Other), Boston Medical Center (Other), Northwestern University (Other)
• Enrollment: 137
• Locations: 4
• Arms: 2
• Anticipated Duration (Months): 59
• Patients Per Site: 34.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 137 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: Jan 1, 2018
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pain diary [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

2. Adaptive coping [Change from baseline to 12 weeks and 26 weeks]

   Coping Strategies Questionnaire for Sickle Cell Disease

Secondary Outcome Measures

1. Treatment acceptability [2 months after starting treatment]

   Treatment Evaluation Inventory

2. Physical and emotional functioning [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

3. Patient Global Impression of Change [12 weeks and 26 weeks]

   Global rating for improvement in pain and functioning

4. Parent protectiveness [Change from baseline to 12 weeks and 26 weeks]

   Adult Responses to Children's Symptoms

5. Health services utilization [Change from baseline to 26 weeks]

   Client Services Receipt Inventory adapted for sickle cell disease

6. Parent psychological distress [Change from baseline to 12 weeks and 26 weeks]

   Symptom Checklist 90

7. Child physical and emotional functioning [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.

8. Unwanted treatment effects [12 weeks and 26 weeks]

   Self report of adverse events during treatment. The number of participants with unwanted treatment effects will be reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Connecticut Children's Medical Center	Hartford	Connecticut	United States	06106
2	Emory University	Atlanta	Georgia	United States	30322
3	Seattle Children's Hospital	Seattle	Washington	United States	98105
4	The Hospital for Sick Children	Toronto	Ontario	Canada

Sponsors and Collaborators

• Seattle Children's Hospital
• 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

• Principal Investigator: Tonya M Palermo, PhD, Seattle Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tonya Palermo, Professor, Anesthesiology and Pain Medicine, Seattle Children's Hospital
• ClinicalTrials.gov Identifier: NCT03201874
• Other Study ID Numbers: R01HD086978
• First Posted: Jun 28, 2017
• Last Update Posted: Sep 16, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• 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

Study Results

No Results Posted as of Sep 16, 2021