Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT05241717

Conditions

Chronic Pain

Survivorship

Childhood Cancer

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Not accepted

Interventions

Web-based Management of Adolescent Pain (WebMAP)

Study Details

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.

Conditions

Chronic Pain

Survivorship

Childhood Cancer

Study ID

NCT05241717

Start date

Jun, 2022

Status verified date

May, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Jul, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

38 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention arm

All study participants will be given the intervention

Interventions

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).

Primary outcome measure

  • Feasibility assessed by the number of participants recruited [ Time Frame: 1 year ]
  • Feasibility assessed by participant retention [ Time Frame: 1 year ]
  • Feasibility assessed by treatment adherence [ Time Frame: 1 year ]
  • Acceptability of intervention assessed by a satisfaction survey [ Time Frame: 3 months after the intervention ]
  • Feasibility, acceptability and satisfaction assessed by qualitative interviews [ Time Frame: Immediately after the intervention ]
  • Satisfaction with intervention modules assessed by a satisfaction survey [ Time Frame: 3 months after the intervention ]

Central Contacts and Locations

Central contacts

Locations

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T2S 3C3

Contacts

More Information

Sponsor

University of Calgary

Last update posted

May 18, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2022-05-18.