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WebMAP for Childhood Cancer Survivors

U

University of Calgary

Status

Unknown

Conditions

Survivorship
Chronic Pain
Childhood Cancer

Treatments

Behavioral: Web-based Management of Adolescent Pain (WebMAP)

Study type

Interventional

Funder types

Other

Identifiers

NCT05241717
HREBA.CC-21-0272

Details and patient eligibility

About

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.

Enrollment

38 estimated patients

Sex

All

Ages

11 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

38 participants in 1 patient group

Intervention arm
Experimental group
Description:
All study participants will be given the intervention
Treatment:
Behavioral: Web-based Management of Adolescent Pain (WebMAP)

Trial contacts and locations

1

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Central trial contact

Michaela Patton, MSc; Fiona Schulte, PhD

Data sourced from clinicaltrials.gov

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