Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
38 participants
INTERVENTIONAL
2022-06-30
2023-12-31
Brief Summary
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Methods: A single-arm mixed-methods pre-post intervention study design will be utilized. Participants will be 34 survivors and at least one of their parents/caregivers. Inclusion criteria are (1) cancer history (2) current age 11-17 years, (3) \>2 years post-treatment or \>5 years post-diagnosis, (4) pain present over prior 3 months impairing \>1 area of daily life and occurring \>1/month , (5) computer access with broadband internet. Survivors will complete a pre-treatment questionnaire, which will include: Child Activity Limitations Interview, the pain intensity Numerical Rating Scale, PROMIS - and Pain Interference, Anxiety, Depression, and Adolescent Sleep Wake Scale. Parents will complete the Pain Catastrophizing Scale - Parent Version and the Adult Responses to Child Symptoms. Upon completion of pre-treatment questionnaires (T0), survivors will begin WebMAP. After the 8 week intervention, survivors will complete the same measures (T1), and at 3 month follow-up (T2). Post-treatment interviews will be conducted to determine acceptability. Feasibility will be assessed via recruitment and retention rates. Treatment engagement will be measured by number of modules completed. Pre-post outcome data will be assessed using Linear Mixed Models. Qualitative data will be analyzed using thematic analysis. Patient and caregiver partners will be involved in study design, recruitment, interpretation of results, and knowledge translation.
Discussion: Investigating whether WebMAP is useful to survivors will be an important step in improving pain management in this population.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention arm
All study participants will be given the intervention
Web-based Management of Adolescent Pain (WebMAP)
Participants will be asked to complete one module per week, which are approximately 20 minutes in length. Survivors and parents will be asked to spend approximately 4.5 hours each over the course of the intervention on WebMAP including 4 hours to complete the modules and 30 minutes total corresponding with a coach. Each week, patients log into WebMAP to learn a new skill and practice that skill for 1 week to allow time for skills acquisition. WebMAP consists of two separate, password-protected programs including one for adolescents and one for parents (http://webmap2.com).
Interventions
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Web-based Management of Adolescent Pain (WebMAP)
Participants will be asked to complete one module per week, which are approximately 20 minutes in length. Survivors and parents will be asked to spend approximately 4.5 hours each over the course of the intervention on WebMAP including 4 hours to complete the modules and 30 minutes total corresponding with a coach. Each week, patients log into WebMAP to learn a new skill and practice that skill for 1 week to allow time for skills acquisition. WebMAP consists of two separate, password-protected programs including one for adolescents and one for parents (http://webmap2.com).
Eligibility Criteria
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Inclusion Criteria
* current age 11-17 years
* at least 2 years post-treatment or completed treatment and at least 5 years post-diagnosis
* pain present over prior 3 months that impairs at least one area of daily life and occurs at least 1/month
* computer access and literacy
Exclusion Criteria
* developmental delays that would prevent them from completing the survey themselves or complete the intervention
* psychosis
11 Years
17 Years
ALL
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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Fiona Simone Maria Schulte
Associate Professor
Principal Investigators
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Fiona Schulte, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Alberta Children's Hospital
Calgary, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Patton M, Carlson LE, Noel M, Palermo T, Forster V, Cho S, Schulte F. Internet-Delivered Cognitive Behavioral Treatment for Chronic Pain in Adolescent Survivors of Childhood Cancer: Protocol for a Single-Group Feasibility Trial. JMIR Res Protoc. 2023 Aug 1;12:e45804. doi: 10.2196/45804.
Other Identifiers
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HREBA.CC-21-0272
Identifier Type: -
Identifier Source: org_study_id
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