Clinical trial NCT03201874: iCanCope With Sickle Cell Pain
Official title: iCanCope With Sickle Cell Disease: A Mobile Pain Management Intervention for Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
name: Emory University
name: Connecticut Children's Medical Center
name: University of Mississippi Medical Center
name: University of Florida
name: Boston Medical Center
name: Northwestern University
First posted: 2017-06-28
Enrollment: 137
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Pain Diary - Average Daily Pain
timeFrame: Baseline,12 weeks, and 26 weeks
measure: Pain Diary - Average Daily Activity Limitations
timeFrame: Baseline,12 weeks, and 26 weeks
measure: Adaptive Coping - Coping Attempts
timeFrame: Baseline,12 weeks, and 26 weeks
Secondary outcomes:
measure: Treatment Acceptability
timeFrame: 2 months after starting treatment
measure: Physical and Emotional Functioning - Depressive Symptoms
timeFrame: Baseline,12 weeks, and 26 weeks
measure: Physical and Emotional Functioning - Anxiety
timeFrame: Baseline,12 weeks, and 26 weeks
measure: Physical and Emotional Functioning - Mobility
timeFrame: Baseline,12 weeks, and 26 weeks
measure: Physical and Emotional Functioning - Pain Interference
timeFrame: Baseline,12 weeks, and 26 weeks
measure: Physical and Emotional Functioning - Fatigue
timeFrame: Baseline,12 weeks, and 26 weeks
measure: Physical and Emotional Functioning - Peer Relationships
timeFrame: Baseline,12 weeks, and 26 weeks
measure: Patient Global Impression of Change
timeFrame: 12 weeks and 26 weeks
measure: Parent Protectiveness
timeFrame: Baseline,12 weeks, and 26 weeks
measure: Health Services Utilization
timeFrame: Baseline and 26 weeks
measure: Parent Psychological Distress
timeFrame: Baseline,12 weeks, and 26 weeks
measure: Child Physical and Emotional Functioning - Parent Report, Social Functioning
timeFrame: Baseline,12 weeks, and 26 weeks
measure: Child Physical and Emotional Functioning - Parent Report, Physical Functioning
timeFrame: Baseline,12 weeks, and 26 weeks
measure: Child Physical and Emotional Functioning - Parent Report, Depression
timeFrame: Baseline,12 weeks, and 26 weeks
measure: Child Physical and Emotional Functioning - Parent Report, General Anxiety
timeFrame: Baseline,12 weeks, and 26 weeks
measure: Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety
timeFrame: Baseline,12 weeks, and 26 weeks
measure: Child Physical and Emotional Functioning - Parent Report, Family Functioning
timeFrame: Baseline,12 weeks, and 26 weeks
measure: Child Physical and Emotional Functioning - Parent Report, Development
timeFrame: Baseline,12 weeks, and 26 weeks
measure: Treatment Experiences - Child
timeFrame: 12 weeks and 26 weeks
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Seattle Children's Hospital
name: Tonya M Palermo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.