Table 1.
Data category | Information | ||
Primary registry and trial identifying number | ClinicalTrials.gov NCT05241717 | ||
Date of registration in primary registry | February 4, 2022 | ||
Sources of monetary or material support | Alberta Children’s Hospital Trainee Small Research Granta | ||
Primary sponsor | Fiona Schulte, PhDa, fsmschul@ucalgary.ca | ||
Contact for public queries | Fiona Schulte, PhD, fsmschul@ucalgary.ca | ||
Public title | Internet-delivered cognitive behavioral treatment for adolescent survivors of childhood cancer with chronic pain | ||
Scientific title | Internet-delivered cognitive behavioral treatment for adolescent survivors of childhood cancer with chronic pain: A pilot feasibility trial | ||
Countries of recruitment | Canada | ||
Health conditions or problems studied | Cancer, chronic pain | ||
Intervention | |||
|
Active comparator | Internet-delivered cognitive behavioral therapy | |
Key inclusion and exclusion criteria | |||
|
Ages eligible for study | 10-17 years | |
|
Sexes eligible for study | Any | |
|
Accepts healthy volunteers | No | |
|
Inclusion criteria | History of any cancer diagnosis, >2 years post treatment or completed treatment and >5 years post diagnosis, pain present over prior 3 months that impairs at least one area of daily life and occurs >1 per month, computer access and literacy. | |
Study type | Interventional study; intervention model: single arm; primary purpose: pain management; phase II | ||
Date of first enrollment | May 24, 2022 | ||
Target sample size | 34 | ||
Recruitment status | Currently recruiting | ||
Primary outcomes | Feasibility, satisfaction | ||
Key secondary outcomes | Pain intensity, activity limitations, anxiety symptoms, depressive symptoms, pain interference, insomnia symptoms, parent catastrophizing about child’s pain, parent distress, parent responses to child’s pain behaviors |
aThe funders will not contribute to any aspects of study design or management. The sponsor will be responsible for overseeing the study, interpretation of data, and the decision to submit the report for publication.