Online Pain Neuroscience Education and Graded Exposure to Movement in Breast Cancer Survivors: Protocol of a Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from quality of life
研究概览
简要总结
Introduction: Pain stands out among the sequelae that affect the quality of life of breast cancer survivors. Pain neuroscience education and graded exposure to movement are therapeutic approaches that have been shown to be effective in the management of chronic pain in other populations. However, there are no previous studies that combine them in this population. Objective: To evaluate the effectiveness of an online physiotherapy focused-person program which combines pain neuroscience education and graded exposure to movement, to improve the quality of life of breast cancer survivors. Methodology: The design of the study is a randomised controlled clinical trial and the sample will be 40 breast cancer survivors with pain in the last 6 months. A random method will be used to assign participants into two groups (experimental and control). The evaluator and statistician will be blinded to participant allocation while the experimental group will receive the therapeutic program which combines pain neuroscience education and graded exposure to movement-based intervention throughout therapeutic yoga; the control will be a passive group. There will be four points of assessment: the main outcome assessed will be quality of life measured by the Functional Assessment of Cancer Therapy - Breast (FACT-B+4) and the secondary outcomes are variables related to pain experience (catastrophising, self-efficacy, kinesiophobia and fear-avoidance behaviours). All will be assessed using validated methods. SPSS program will be used for the data analysis. A mixed-model analyses of variance ANOVA (2x4) will be used to study the effects of the treatment on the dependent variables. An intention-to-treat analysis will be performed. All statistical tests will be performed considering a confidence interval of 95%. Trial record: NCT04965909.
详细描述
Study Design A randomised controlled clinical trial will be carried out according to the Consolidated Standards of Reporting Trials (CONSORT) Statement for its development. In addition, the Template for Intervention, Description and Replication Checklist (TIDieR) will be used as a guide to provide transparency and make the intervention replicable. Also, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) was followed to develop this protocol. The protocol of this study has been registered on clinicaltrials.org with the registry number: NCT04965909.
Sampling method and sample's size calculation For sampling, non-probabilistic convenience and snowball methods will be used. Sample size was calculated using the G*Power software, version 3.1.9.7 (Heinrich-Heine University, Düsseldorf, Germany), and considering the previous data reported by Park et al., (2012) for the variable global Quality of life (Functional Assessment of Cancer Therapy - Breast, FACT-B). We considered 2 groups and 4 measurements, a type I risk or α 0.05, type II risk or β 0.20 (study power of 80%), and a partial Eta2 effect size of 0.049. This generated a sample of 40 individuals, including an estimated 15% dropout rate. Figure 1 shows the study flow diagram.
Subjects' recruitment The sample for this study will be recruited through the dissemination of the project using social networks and with the collaboration of three Spanish breast carcer survivor support associations (Amama Sevilla, AGAMAMA and ASAMMA). Participation in the study will be voluntary. All participants will be facilitated by written informed consent that must be signed to be part of the clinical trial.
Group assignment and masking This study will have two groups (experimental and control). For assignment, a random method will be carried out using an online tool called 'random allocation software'. A stratified allocation was applied according to the women's age (≤45 years old or >45 years old). On each of the strata, a randomisation will be carried out by blocks of constant size. The assignment sequence will be hidden from the evaluator and the study subjects through an automated assignment system. The preparation of the sequence, the inclusion of the individuals in each group and the assignment of the treatments will be carried out by different members of the research team. On the other hand, the evaluator and statistician will be blinded. Nonetheless, the therapist and subject will not be able to be blinded because of the type of intervention.
Assessment points, method of data collection and outcomes The outcomes will be assessed at four points during the entire study period: before the intervention (T0), after the experimental group completes the first part of the intervention based on PNE (T1), after complete intervention (T2) and at the 3-month follow-up (T3) (Figure 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
double-blind (researcher and statistician)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from quality of life
时间窗: Four evaluations will be made, before the intervention (T0, at the baseline), at the end of the application of PNE module (T1, 1 month), at the end of the GEM intervention (T2, 3 month) and at 3 months of follow-up (T3).
Quality of life measured by the Functional Assessment of Cancer Therapy - Breast (FACT-B+4). The FACT-B+4 is a 41-item instrument designed to measure six domains of QOL in breast cancer patients: Physical, social, emotional and functional well-being, and breast-cancer (BCS) and lymphedema (ARM) subscales. The score obtained ranges from 0-148 points. The ARM subscale was not included in the total score. A higher score translates into a better quality of life.
次要结局
- Change from catastrophism level(Four evaluations will be made, before the intervention (T0, at the baseline), at the end of the application of PNE module (T1, 1 month), at the end of the GEM intervention (T2, 3 month) and at 3 months of follow-up (T3).)
- Change from pain intensity(Four evaluations will be made, before the intervention (T0, at the baseline), at the end of the application of PNE module (T1, 1 month), at the end of the GEM intervention (T2, 3 month) and at 3 months of follow-up (T3).)
- Change from Kinesiophobia(Four evaluations will be made, before the intervention (T0, at the baseline), at the end of the application of PNE module (T1, 1 month), at the end of the GEM intervention (T2, 3 month) and at 3 months of follow-up (T3).)
- Change from self-efficacy level(Four evaluations will be made, before the intervention (T0, at the baseline), at the end of the application of PNE module (T1, 1 month), at the end of the GEM intervention (T2, 3 month) and at 3 months of follow-up (T3).)
- Change from Fear Avoidance Beliefs(Four evaluations will be made, before the intervention (T0, at the baseline), at the end of the application of PNE module (T1, 1 month), at the end of the GEM intervention (T2, 3 month) and at 3 months of follow-up (T3).)
研究者
Patricia Martínez Miranda
Doctoranda Programa del Doctorado Interuniversitario en CCSS
University of Seville