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Completed

NCT Number: NCT03201874

iCanCope With Sickle Cell Pain

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Education

Behavioral

Education about sickle cell disease to increase disease knowledge

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2017
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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