Internet-Delivered Cognitive Behavioral Treatment for Chronic Pain in Adolescent Survivors of Childhood Cancer: A Single-group Feasibility Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Satisfaction with intervention modules assessed by a satisfaction survey
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
All participants will be provided the intervention
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •not able to read/understand English
- •developmental delays that would prevent them from completing the survey themselves or complete the intervention
- •psychosis
结局指标
主要结局
Satisfaction with intervention modules assessed by a satisfaction survey
时间窗: 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 assessed by the number of participants recruited
时间窗: 1 year
The number of participants recruited for the study will be part of the assessment of the feasibility of the trial.
Acceptability of intervention assessed by a satisfaction survey
时间窗: 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 assessed by treatment adherence
时间窗: 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.
Feasibility assessed by participant retention
时间窗: 1 year
The number of participants who complete the study will be part of the assessment of the feasibility of the trial.
Feasibility, acceptability and satisfaction assessed by qualitative interviews
时间窗: 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.
次要结局
- Sleep quality assessed by the Adolescent Sleep Wake Scale(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)
- Catastrophizing about child's pain assessed by the Pain Catastrophizing Scale-Parent Version(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(Baseline, immediatly after the intervention, 3 months after the intervention)
- Parent distress assessed by the Kessler Psychological Distress Scale(Baseline, immediatly after the intervention, 3 months after the intervention)
- Pain intensity assessed by a pain rating(Baseline, immediatly after the intervention, 3 months after the intervention)
研究者
Fiona Simone Maria Schulte
Associate Professor
University of Calgary