Internet-Delivered Cognitive Behavioral Treatment for Chronic Pain in Adolescent Survivors of Childhood Cancer: Protocol for a Single-Group Feasibility Trial.

cancer survivor cancer survivorship chronic health conditions chronic pain cognitive behavioral therapy eHealth intervention late effects mental health pain management pediatric cancer pediatric oncology psychological difficulties youth

Journal

JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504

Informations de publication

Date de publication:
01 Aug 2023
Historique:
received: 17 01 2023
accepted: 13 06 2023
revised: 12 06 2023
medline: 1 8 2023
pubmed: 1 8 2023
entrez: 1 8 2023
Statut: epublish

Résumé

There are over 500,000 survivors of childhood cancer in North America alone. One in 4 survivors experiences chronic pain after treatment has been completed. Youths with chronic pain report increased anxiety, depression, activity limitations, and sleep disturbances. An 8-week web-based cognitive behavioral treatment for chronic pain (Web-Based Management of Adolescent Pain [WebMAP]) has demonstrated a reduction in pain in youths but has not yet been explored in survivors. The objectives of this 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. A single-arm mixed methods pre-post intervention study design will be used. Participants will be 34 survivors and at least one of their parents or caregivers. Inclusion criteria are (1) a cancer history, (2) current age of 10-17 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 time per month, and (5) computer access with broadband internet. Survivors will complete a pretreatment questionnaire, which will include the following: the Child Activity Limitations Interview, the pain intensity Numerical Rating Scale, Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Interference, Anxiety, Depression, Insomnia Severity Index, and Adolescent Sleep Wake Scale. Parents will complete the Pain Catastrophizing Scale-Parent Version and the Adult Responses to Child Symptoms. Upon completion of pretreatment 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). Posttreatment 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 partners will be involved in study design, recruitment, interpretation of results, and knowledge translation. This study has been funded in January 2022. Data collection started in May 2022 and is projected to end in August 2023. We have enrolled 10 participants as of December 2022. Investigating whether WebMAP is useful to survivors will be an important step in improving pain management in this population. ClinicalTrials.gov NCT05241717; https://clinicaltrials.gov/ct2/show/NCT05241717. DERR1-10.2196/45804.

Sections du résumé

BACKGROUND BACKGROUND
There are over 500,000 survivors of childhood cancer in North America alone. One in 4 survivors experiences chronic pain after treatment has been completed. Youths with chronic pain report increased anxiety, depression, activity limitations, and sleep disturbances. An 8-week web-based cognitive behavioral treatment for chronic pain (Web-Based Management of Adolescent Pain [WebMAP]) has demonstrated a reduction in pain in youths but has not yet been explored in survivors.
OBJECTIVE OBJECTIVE
The objectives of this 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 METHODS
A single-arm mixed methods pre-post intervention study design will be used. Participants will be 34 survivors and at least one of their parents or caregivers. Inclusion criteria are (1) a cancer history, (2) current age of 10-17 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 time per month, and (5) computer access with broadband internet. Survivors will complete a pretreatment questionnaire, which will include the following: the Child Activity Limitations Interview, the pain intensity Numerical Rating Scale, Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Interference, Anxiety, Depression, Insomnia Severity Index, and Adolescent Sleep Wake Scale. Parents will complete the Pain Catastrophizing Scale-Parent Version and the Adult Responses to Child Symptoms. Upon completion of pretreatment 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). Posttreatment 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 partners will be involved in study design, recruitment, interpretation of results, and knowledge translation.
RESULTS RESULTS
This study has been funded in January 2022. Data collection started in May 2022 and is projected to end in August 2023. We have enrolled 10 participants as of December 2022.
CONCLUSIONS CONCLUSIONS
Investigating whether WebMAP is useful to survivors will be an important step in improving pain management in this population.
TRIAL REGISTRATION BACKGROUND
ClinicalTrials.gov NCT05241717; https://clinicaltrials.gov/ct2/show/NCT05241717.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) UNASSIGNED
DERR1-10.2196/45804.

Identifiants

pubmed: 37526959
pii: v12i1e45804
doi: 10.2196/45804
pmc: PMC10427928
doi:

Banques de données

ClinicalTrials.gov
['NCT05241717']

Types de publication

Journal Article

Langues

eng

Pagination

e45804

Informations de copyright

©Michaela Patton, Linda E Carlson, Melanie Noel, Tonya Palermo, Victoria Forster, Sara Cho, Fiona Schulte. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 01.08.2023.

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Auteurs

Michaela Patton (M)

Department of Psychology, University of Calgary, Calgary, AB, Canada.

Linda E Carlson (LE)

Department of Psychology, University of Calgary, Calgary, AB, Canada.

Melanie Noel (M)

Department of Psychology, University of Calgary, Calgary, AB, Canada.

Tonya Palermo (T)

Seattle Children's Research Institute, Seattle, WA, United States.

Victoria Forster (V)

The Hospital for Sick Children, Toronto, ON, Canada.

Sara Cho (S)

Department of Psychology, University of Calgary, Calgary, AB, Canada.

Fiona Schulte (F)

Department of Psychology, University of Calgary, Calgary, AB, Canada.

Classifications MeSH