Clinical trial NCT05241717: WebMAP for Childhood Cancer Survivors
Official title: Internet-Delivered Cognitive Behavioral Treatment for Chronic Pain in Adolescent Survivors of Childhood Cancer: A Single-group Feasibility Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Survivorship
Childhood Cancer
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 38
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mixed methods, single-arm feasibility study
Primary purpose: TREATMENT

Brief summary: Background: There are over 500,000 survivors of childhood cancer in North America alone. One in four survivors experiences chronic pain after treatment has completed. Youth with chronic pain report increased anxiety, depression, activity limitations, and sleep disturbances. An 8-week web-based cognitive-behavioral treatment for chronic pain (WebMAP) has demonstrated reduction in the pain in children but has not yet been explored in survivors. The objectives of the current study are to (1) test the feasibility and acceptability of WebMAP for a sample of survivors with chronic pain and their parents, (2) assess the acceptability of WebMAP using qualitative interviews, (3) assess WebMAP's effect on activity limitations, pain intensity, depression and anxiety symptoms, and sleep disturbances, and (4) assess WebMAP's effect on parent pain catastrophizing and parental response to their child's pain.

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.


Eligibility criteria: Inclusion Criteria:

* history of any cancer diagnosis
* 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:

* not able to read/understand English
* developmental delays that would prevent them from completing the survey themselves or complete the intervention
* psychosis

Primary outcomes:
measure: Feasibility assessed by the number of participants recruited
timeFrame: 1 year
measure: Feasibility assessed by participant retention
timeFrame: 1 year
measure: Feasibility assessed by treatment adherence
timeFrame: 1 year
measure: Acceptability of intervention assessed by a satisfaction survey
timeFrame: 3 months after the intervention
measure: Feasibility, acceptability and satisfaction assessed by qualitative interviews
timeFrame: Immediately after the intervention
measure: Satisfaction with intervention modules assessed by a satisfaction survey
timeFrame: 3 months after the intervention
Secondary outcomes:
measure: Pain intensity assessed by a pain rating
timeFrame: Baseline, immediatly after the intervention, 3 months after the intervention
measure: Activity Limitations assessed by the Child Activity Limitations Interview
timeFrame: Baseline, immediatly after the intervention, 3 months after the intervention
measure: Anxiety and depressive symptoms and pain interference assessed by Patient Reported Outcomes Measurement Information System (PROMIS) measures
timeFrame: Baseline, immediatly after the intervention, 3 months after the intervention
measure: Sleep quality assessed by the Adolescent Sleep Wake Scale
timeFrame: Baseline, immediatly after the intervention, 3 months after the intervention
measure: Catastrophizing about child's pain assessed by the Pain Catastrophizing Scale-Parent Version
timeFrame: Baseline, immediatly after the intervention, 3 months after the intervention
measure: Parental responses to child's pain behaviors assessed by the Adult Responses to Children's Symptoms
timeFrame: Baseline, immediatly after the intervention, 3 months after the intervention
measure: Parent distress assessed by the Kessler Psychological Distress Scale
timeFrame: Baseline, immediatly after the intervention, 3 months after the intervention
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Fiona Schulte, PhD
role: PRINCIPAL_INVESTIGATOR
References: