WebMAP for Childhood Cancer Survivors

NCT ID: NCT05241717

Last Updated: 2022-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain Survivorship Childhood Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Mixed methods, single-arm feasibility study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

All participants will be provided the intervention

Study Groups

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Intervention arm

All study participants will be given the intervention

Group Type EXPERIMENTAL

Web-based Management of Adolescent Pain (WebMAP)

Intervention Type 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).

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Fiona Simone Maria Schulte

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fiona Schulte, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Fiona Schulte, PhD

Role: CONTACT

403-698-8103

Michaela Patton, MSc

Role: CONTACT

Facility Contacts

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Fiona Schulte

Role: primary

4036988103

References

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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.

Reference Type DERIVED
PMID: 37526959 (View on PubMed)

Other Identifiers

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HREBA.CC-21-0272

Identifier Type: -

Identifier Source: org_study_id

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