WebMAP for Childhood Cancer Survivors

NCT05241717 | Unknown

• 1 other identifier: HREBA.CC-21-0272
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Feasibility assessed by the number of participants recruited

  The number of participants recruited for the study will be part of the assessment of the feasibility of the trial.

  1 year

• Feasibility assessed by participant retention

  The number of participants who complete the study will be part of the assessment of the feasibility of the trial.

  1 year

• Feasibility assessed by treatment adherence

  The number of participants who complete at least 6 of the 8 modules of the intervention will be part of the assessment of the feasibility of the trial.

  1 year

• Acceptability of intervention assessed by a satisfaction survey

  A survey including open-ended questions will be created with patient partners to elicit feedback on specific modules. These questions will ask about what information was helpful and what may need to be adjusted to better serve youth with a history of cancer for both patients and parents. The satisfaction survey will be completed as part of the post-treatment questionnaire.

  3 months after the intervention

• Feasibility, acceptability and satisfaction assessed by qualitative interviews

  Semi-structured interviews will be conducted with survivors upon treatment completion to assess feasibility, acceptability, and satisfaction with the program. Patient partners will be involved in creating the standard set of questions.

  Immediately after the intervention

• Satisfaction with intervention modules assessed by a satisfaction survey

  A survey including open-ended questions will be created with patient partners to elicit feedback on specific modules. These questions will ask about what information was helpful and what may need to be adjusted to better serve youth with a history of cancer for both patients and parents. The satisfaction survey will be completed as part of the post-treatment questionnaire.

  3 months after the intervention

Secondary Outcomes (7)

• Pain intensity assessed by a pain rating

  Baseline, immediatly after the intervention, 3 months after the intervention

• Activity Limitations assessed by the Child Activity Limitations Interview

  Baseline, immediatly after the intervention, 3 months after the intervention

• Anxiety and depressive symptoms and pain interference assessed by Patient Reported Outcomes Measurement Information System (PROMIS) measures

  Baseline, immediatly after the intervention, 3 months after the intervention

• Sleep quality assessed by the Adolescent Sleep Wake Scale

  Baseline, immediatly after the intervention, 3 months after the intervention

• Catastrophizing about child's pain assessed by the Pain Catastrophizing Scale-Parent Version

  Baseline, immediatly after the intervention, 3 months after the intervention

Study Arms (1)

Intervention arm

EXPERIMENTAL

All study participants will be given the intervention

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

Interventions

Web-based Management of Adolescent Pain (WebMAP) BEHAVIORAL

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).

Intervention arm

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T2S 3C3, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 37526959 DERIVED

MeSH Terms

Conditions

Chronic Pain; Neoplasms

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fiona Schulte, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiona Schulte, PhD

CONTACT

403-698-8103; fsmschul@ucalgary.ca

Michaela Patton, MSc

CONTACT

michaela.patton@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants will be provided the intervention
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Mixed methods, single-arm feasibility study

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: February 16, 2022
• Study Start: June 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available after initial publication until 5 years after study completion.
• Access Criteria: A .sps file of deidentified data will be shared upon request to the research contact.

Locations

CA (1)