Chronic PainNCT05241717
WebMAP for Childhood Cancer Survivors
A study testing Web-based Management of Adolescent Pain (WebMAP) in people with Chronic Pain and Survivorship, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Chronic Pain, Survivorship, Childhood Cancer
- What is being tested?
- Web-based Management of Adolescent Pain (WebMAP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- not able to read/understand English
- developmental delays that would prevent them from completing the survey themselves or complete the intervention
- psychosis
Trial locations and contacts
1 site in 1 country.
Michaela Patton, MSc contact
Canada1 site, 1 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta, T2S 3C3
Fiona Schulte, 4036988103, fsmschul@ucalgary.ca
About this study
Official title: Internet-Delivered Cognitive Behavioral Treatment for Chronic Pain in Adolescent Survivors of Childhood Cancer: A Single-group Feasibility Trial
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
- Being tested
- Web-based Management of Adolescent Pain (WebMAP)
- Medical subject headings
- Chronic Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based Management of Adolescent Pain (WebMAP)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | All study participants will be given the intervention Receives: Behavioral: Web-based Management of Adolescent Pain (WebMAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months after the intervention
Secondary outcomes (7)
Pain intensity assessed by a pain rating
Daily surveys, administered through REDCap, will be used to assess daily presence of pain and pain intensity for 7 days at each assessment period. Pain intensity will be assessed with an item asking about the magnitude of pain experienced answered on an 11-point numerical rating scale (0 = no pain, 10 = worst pain). This measure of pain intensity has demonstrated to be a reliable and valid measure of pain in many populations of children 8 years and older (Baeyer et al., 2009; Castarlenas, Jensen, Baeyer, \& Miro, 2017), but has not yet been validated in people with cancer.
Measured: Baseline, immediatly after the intervention, 3 months after the intervention
Activity Limitations assessed by the Child Activity Limitations Interview
The Child Activity Limitations Interview is a measure of children's perceived difficulty in completing typical daily activities because of pain. The CALI will be collected for 1 week at each of the study timepoints. Survivors will choose the top 8 activities from a list of 21 and will be asked each day whether the activity occurred and how difficult the activity was to perform because of their pain. Difficulty ratings are measures on a five-point scale (0 = no difficulty, 4 = extremely difficult), with a range of zero to 32. Higher scores indicate greater functional limitations. Average daily limitation scores across each assessment period will be computed.
Measured: 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
The PROMIS Anxiety and Depression instruments (Cook, Reeve, Ader, \& Fries, 2010(31)) (8-item short form) will be administered via REDCap to screen for current symptoms of anxiety and depression. Survivors will complete the self-report instrument corresponding to their age (child: age 8-17; adult: age 18+). Items (e.g., "I felt worried") are rated on a five-point scale (1 = never, 5 = always). Higher scores signify greater severity of symptoms. Pain interference will be assessed using the four-item PROMIS interference scale for survivors 8-17 years of age, and the seven-item PROMIS interference scale for survivors over 18 years of age (Hinds et al., 2013). The PROMIS pediatric measures have been validated for use in pediatric oncology (Hinds et al., 2013).
Measured: Baseline, immediatly after the intervention, 3 months after the intervention
Sleep quality assessed by the Adolescent Sleep Wake Scale
The Adolescent Sleep Wake Scale (ASWS-S) (32, 33) is a measure of the subjective perception of sleep quality. The ASWS-S is a 10-item measure where items representing symptoms of sleep disturbance are scored on a 6-point Likert scale (1 = always, 6 = never), and will be administered online via REDCap. The measure produces a total sum score where higher scores represent more severe sleep disturbance. The ASWS has demonstrated acceptable reliability and validity among populations of youth with comorbid sleep and medical conditions (34) and among ethnically diverse youth (33).
Measured: Baseline, immediatly after the intervention, 3 months after the intervention
Catastrophizing about child's pain assessed by the Pain Catastrophizing Scale-Parent Version
The Pain Catastrophizing Scale - Parent Version (PCS-P) (37) is a 13-item measure used to assess parents' catastrophic thoughts and feelings about their child's pain and will be administered online via REDCap. Parents rate statements about their child's pain on a five-point Likert scale (i.e., "When my child has pain, I can't keep it out of my mind"). Items are summed to yield a total score and can also be summed to provide scores on three subscales: rumination, magnification, and helplessness. Lower scores indicate less catastrophizing. This scale has been found to have good reliability in parents with children who experience pain.
Measured: Baseline, immediatly after the intervention, 3 months after the intervention
Parental responses to child's pain behaviors assessed by the Adult Responses to Children's Symptoms
The Adult Responses to Children's Symptoms (ARCS) (38, 39) measures parental responses to their child's pain behaviors and will be administered online via REDCap. The current study will only utilize the Protect subscale, which assesses parents' responses that either positively or negatively reinforce pain complaints. Parents' responses are rated on a five-point scale (0 = never, 4 = always). Subscale scores represent an average of the items, with higher scores indicating more frequent use of that behavioral style. This scale has demonstrated reliability and validity for use with parents of children with chronic pain (38, 39).
Measured: Baseline, immediatly after the intervention, 3 months after the intervention
Parent distress assessed by the Kessler Psychological Distress Scale
The Kessler Psychological Distress Scale (40) is a 6-item measure used to assess non-specific psychological distress representing diagnoses of major depression and generalized anxiety disorder and also contains a positive affect domain. The measure has good precision in the 90-99th percentile range of the population, and has solid psychometric properties across major sociodemographic populations distribution in the United States of America and Canada (40). It also strongly discriminates between meeting and not meeting diagnostic thresholds for psychological disorders (40).
Measured: Baseline, immediatly after the intervention, 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study startJun 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mixed methods, single-arm feasibility study
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona Simone Maria Schulte, University of Calgary
- Investigators
- Fiona Schulte, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241717
- Sponsor's protocol ID
- HREBA.CC-21-0272
- Status last verified
- May 2022
- First submitted
- 26 Oct 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All deidentified IPD will be provided upon request.
Publications
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.
PubMed 37526959
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Delivered Cognitive Behavioral Treatment for Chronic Pain in Adolescent Survivors of Childhood Cancer: A Single-group Feasibility Trial
- ClinicalTrials.gov ID
- NCT05241717
- Acronym / sponsor ID
- HREBA.CC-21-0272
- Conditions
- Chronic Pain, Survivorship, Childhood Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mixed methods, single-arm feasibility study
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Web-based Management of Adolescent Pain (WebMAP)All study participants will be given the intervention |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- not able to read/understand English
- developmental delays that would prevent them from completing the survey themselves or complete the intervention
- psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Intervention arm |
Primary outcome
Feasibility assessed by the number of participants recruited
Time frame: 1 year
The number of participants recruited for the study will be part of the assessment of the feasibility of the trial.
Feasibility assessed by participant retention
Time frame: 1 year
The number of participants who complete the study will be part of the assessment of the feasibility of the trial.
Feasibility assessed by treatment adherence
Time frame: 1 year
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.
Acceptability of intervention assessed by a satisfaction survey
Time frame: 3 months after the intervention
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.
Feasibility, acceptability and satisfaction assessed by qualitative interviews
Time frame: Immediately after the intervention
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.
Satisfaction with intervention modules assessed by a satisfaction survey
Time frame: 3 months after the intervention
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.
7 secondary outcomes
Pain intensity assessed by a pain rating
Time frame: Baseline, immediatly after the intervention, 3 months after the intervention
Activity Limitations assessed by the Child Activity Limitations Interview
Time frame: 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
Time frame: Baseline, immediatly after the intervention, 3 months after the intervention
Sleep quality assessed by the Adolescent Sleep Wake Scale
Time frame: Baseline, immediatly after the intervention, 3 months after the intervention
Catastrophizing about child's pain assessed by the Pain Catastrophizing Scale-Parent Version
Time frame: Baseline, immediatly after the intervention, 3 months after the intervention
Parental responses to child's pain behaviors assessed by the Adult Responses to Children's Symptoms
Time frame: Baseline, immediatly after the intervention, 3 months after the intervention
Parent distress assessed by the Kessler Psychological Distress Scale
Time frame: Baseline, immediatly after the intervention, 3 months after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 37526959Patton 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.
- Individual participant dataSharing planned: Yes. All deidentified IPD will be provided upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michaela Patton, MSc contact
Fiona Schulte, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based Management of Adolescent Pain (WebMAP) in people with Chronic Pain and Survivorship, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fiona Schulte, PhD (403-698-8103, fsmschul@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility assessed by the number of participants recruited (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05241717, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.