iCanCope With Sickle Cell Pain

NCT03201874 | Completed Results DMC

• 1 other identifier: R01HD086978
• Study Type: interventional
• Target: 137
• Locations: 2 countries
• Sites: 4

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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (19)

• Treatment Acceptability

  2 months after starting treatment

• Physical and Emotional Functioning - Depressive Symptoms

  Baseline,12 weeks, and 26 weeks

• Physical and Emotional Functioning - Anxiety

  Baseline,12 weeks, and 26 weeks

• Physical and Emotional Functioning - Mobility

  Baseline,12 weeks, and 26 weeks

• Physical and Emotional Functioning - Pain Interference

  Baseline,12 weeks, and 26 weeks

Study Arms (2)

Education Control

ACTIVE COMPARATOR

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

Pain Self-Management Intervention

EXPERIMENTAL

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; Behavioral: Education

Interventions

Pain self-management BEHAVIORAL

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.

Pain Self-Management Intervention

Education BEHAVIORAL

Education about sickle cell disease to increase disease knowledge

Education Control; Pain Self-Management Intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• The Hospital for Sick Children: collaborator
• Emory University: collaborator
• Connecticut Children's Medical Center: collaborator
• University of Mississippi Medical Center: collaborator
• University of Florida: collaborator
• Boston Medical Center: collaborator
• Northwestern University: collaborator

Study Sites (4)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Related Publications (3)

• Palermo TM, Srinakarin K, Zhou C, Lalloo C, Dampier C, Zempsky WT, Badawy SM, Bakshi N, Ko YJ, Nishat F, Stinson JN. Moderators of digital cognitive-behavioral therapy for youth with sickle cell disease pain: secondary analysis of a randomized controlled trial. Pain. 2025 Mar 13;166(9):e233-e243. doi: 10.1097/j.pain.0000000000003583.

  PMID: 40839690 DERIVED

• Palermo TM, Lalloo C, Zhou C, Dampier C, Zempsky W, Badawy SM, Bakshi N, Ko YJ, Nishat F, Stinson JN. A cognitive-behavioral digital health intervention for sickle cell disease pain in adolescents: a randomized, controlled, multicenter trial. Pain. 2024 Jan 1;165(1):164-176. doi: 10.1097/j.pain.0000000000003009. Epub 2023 Sep 21.

  PMID: 37733479 DERIVED

• 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.

  PMID: 36040789 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Limitations and Caveats

Our trial recruitment and data collection spanned dates from before the COVID-19 pandemic to during the pandemic. This factor had an impact on our ability to reach our target enrollment into the trial as well as potential effects on outcome measurement. Despite the strength of our high retention rate in the trial, we had a high level of missingness for some outcome data

Results Point of Contact

• Title: Tonya Palermo, Professor, Anesthesiology and Pain Medicine, Seattle Children's Hospital
• Organization: Seattle Children's Hospital

tonya.palermo@seattlechildrens.org

206-884-4208

Study Officials

• Tonya M Palermo, PhD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Anesthesiology and Pain Medicine

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: June 28, 2017
• Study Start: January 1, 2018
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: December 13, 2023
• Results First Posted: December 13, 2023

Record last verified: 2023-11

Locations

CA (1); US (3)