iCanCope With Sickle Cell Pain

November 21, 2023 updated by: Tonya Palermo, Seattle Children's Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
137

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Diary - Average Daily Pain
Time Frame: Baseline,12 weeks, and 26 weeks
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
Time Frame: Baseline,12 weeks, and 26 weeks
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
Time Frame: Baseline,12 weeks, and 26 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment Acceptability
Time Frame: 2 months after starting treatment
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
Time Frame: Baseline,12 weeks, and 26 weeks
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
Time Frame: Baseline,12 weeks, and 26 weeks
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
Time Frame: Baseline,12 weeks, and 26 weeks
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
Time Frame: Baseline,12 weeks, and 26 weeks
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
Time Frame: Baseline,12 weeks, and 26 weeks
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
Time Frame: Baseline,12 weeks, and 26 weeks
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
Time Frame: 12 weeks and 26 weeks
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
Time Frame: Baseline,12 weeks, and 26 weeks
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
Time Frame: Baseline and 26 weeks
Client Services Receipt Inventory adapted for sickle cell disease - Number of hospitalizations and/or ED visits
Baseline and 26 weeks
Parent Psychological Distress
Time Frame: Baseline,12 weeks, and 26 weeks
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
Time Frame: Baseline,12 weeks, and 26 weeks
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
Time Frame: Baseline,12 weeks, and 26 weeks
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
Time Frame: Baseline,12 weeks, and 26 weeks
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
Time Frame: Baseline,12 weeks, and 26 weeks
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
Time Frame: Baseline,12 weeks, and 26 weeks
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
Time Frame: Baseline,12 weeks, and 26 weeks
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
Time Frame: Baseline,12 weeks, and 26 weeks
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
Time Frame: 12 weeks and 26 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seattle Children's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tonya M Palermo, PhD, Seattle Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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