iCanCope With Sickle Cell Pain

iCanCope With Sickle Cell Disease: A Mobile Pain Management Intervention for Adolescents

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.

Study Overview

• Status: Completed
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Behavioral: Education; Behavioral: Pain self-management

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
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • The Hospital for Sick Children
• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connecticut Children's Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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: Education; Education about sickle cell disease to increase disease knowledge; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Diary - Average Daily Pain	App diary using an 11-point numerical rating scale for pain intensity for 7 days Scores range from 0-10 where higher scores indicate a worse outcome	Baseline,12 weeks, and 26 weeks
Pain Diary - Average Daily Activity Limitations	App diary using Child Activity Limitations Inventory 9-items to measure activity limitations for 7 days Scores range from 0-100 where higher scores mean a worse outcome	Baseline,12 weeks, and 26 weeks
Adaptive Coping - Coping Attempts	Coping Strategies Questionnaire for Sickle Cell Disease - Coping Attempts Factor Scores range from 0 - 180, higher scores mean a better outcome	Baseline,12 weeks, and 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Acceptability	Treatment Evaluation Inventory scores range from 9 - 45 where higher scores mean a better outcome	2 months after starting treatment
Physical and Emotional Functioning - Depressive Symptoms	Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Depressive Symptoms T-score, higher scores means higher depressive symptoms. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of depressive symptoms.	Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Anxiety	Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Anxiety T-score, higher scores means higher levels of anxiety. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of anxiety.	Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Mobility	Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Mobility T-score, higher scores means better mobility. 50 indicates the population mean with a standard deviation of 10. A T-score of 40 is indicative of sub-clinical mobility limitations.	Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Pain Interference	Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Pain Interference T-score, higher scores means more pain interference. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of pain interference.	Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Fatigue	Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Fatigue T-score, higher scores means higher levels of fatigue. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of fatigue.	Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Peer Relationships	Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Peer Relationships T-score, higher scores means better peer relationships. 50 indicates the population mean with a standard deviation of 10. A T-score of 40 is indicative of sub-clinical or reduced quality of peer relationships.	Baseline,12 weeks, and 26 weeks
Patient Global Impression of Change	Global rating for improvement in pain and functioning Scores range from 1-7 where higher scores mean a better outcome	12 weeks and 26 weeks
Parent Protectiveness	Adult Responses to Children's Symptoms Scores range from 0-4 where higher scores mean a worse outcome	Baseline,12 weeks, and 26 weeks
Health Services Utilization	Client Services Receipt Inventory adapted for sickle cell disease - Number of hospitalizations and/or ED visits	Baseline and 26 weeks
Parent Psychological Distress	Symptom Checklist 90 - Global Severity Index Scores range from 0-4, with higher scores indicating a worse outcome	Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Social Functioning	Bath Adolescent Pain Questionnaire - Parent version, Social Functioning (score range: 0-36). A higher score indicates more impaired functioning for all subscales.	Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Physical Functioning	Bath Adolescent Pain Questionnaire - Parent version Physical Functioning (0-36). A higher score indicates more impaired functioning for all subscales.	Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Depression	Bath Adolescent Pain Questionnaire - Parent version, Depression (0-24). A higher score indicates more impaired functioning for all subscales.	Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, General Anxiety	Bath Adolescent Pain Questionnaire - Parent version, General Anxiety (0-28). A higher score indicates more impaired functioning for all subscales.	Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety	Bath Adolescent Pain Questionnaire - Parent version, Pain Specific Anxiety (0-28). A higher score indicates more impaired functioning for all subscales.	Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Family Functioning	Bath Adolescent Pain Questionnaire - Parent, Family Functioning (0-48). A higher score indicates more impaired functioning for all subscales.	Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Development	Bath Adolescent Pain Questionnaire - Parent version, Development (0-44). A higher score indicates more impaired functioning for all subscales.	Baseline,12 weeks, and 26 weeks
Treatment Experiences - Child	Self report of treatment experiences. The number of participants with high levels of increased stress or anxiety will be reported.	12 weeks and 26 weeks

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: The Hospital for Sick Children; Northwestern University; Emory University; University of Florida; Boston Medical Center; University of Mississippi Medical Center; Connecticut Children's Medical Center
• Investigators: Principal Investigator: Tonya M Palermo, PhD, Seattle Children's Hospital

Publications and helpful links

General Publications

• Lalloo C, Nishat F, Zempsky W, Bakshi N, Badawy S, Ko YJ, Dampier C, Stinson J, Palermo TM. Characterizing User Engagement With a Digital Intervention for Pain Self-management Among Youth With Sickle Cell Disease and Their Caregivers: Subanalysis of a Randomized Controlled Trial. J Med Internet Res. 2022 Aug 30;24(8):e40096. doi: 10.2196/40096.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: R01HD086978 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No