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临床试验/NCT03782506
NCT03782506已完成不适用

The Impact of Music Therapy on Opioid Use in Cancer Survivors With Chronic Pain

Drexel University6 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
6
主要终点
Daily opioid dose

研究概览

简要总结

Pain in cancer survivors is difficult to treat, and unrelieved pain can greatly reduce a person's quality of life. Opioids are often prescribed for pain management, yet they can have undesirable side effects and may put someone at risk for addiction or dependence. The purpose of this study is to examine the impact of an interactive music therapy intervention on pain management and opioid use in cancer survivors.

详细描述

As many as 40% of cancer survivors report experiencing chronic pain, and recent research indicates that pain is not well managed. Opioids are often prescribed during active cancer treatment for pain management, and many cancer survivors continue the same pain management regimen long after completing their cancer treatment. Reports indicate that prescription rates are up to 1.22 times higher for cancer cancer survivors than people without a cancer diagnosis, and the American Society of Clinical Oncology recommends that opioid tapering should be a priority once someone moves into survivorship status. Music interventions have been used for pain management in people with cancer, yet few studies have examined music therapy for chronic pain in cancer survivors. Moreover, none of these studies have not examined opioid use as a measure. Therefore, the overarching goals of this pilot study are to investigate the impact of an interactive music therapy (IMT) intervention on pain management and opioid use in cancer survivors with chronic pain versus a verbal-based support program (social attention control). This pilot study uses a mixed methods intervention design in which qualitative data (i.e. semi-structured follow-up interviews) are embedded within a randomized controlled trial. We will randomize 40 cancer survivors to one of two 10-session treatments: 1) Interactive Music Therapy or 2) Social Attention Control. Primary (mean daily opioid use) and secondary outcomes (pain intensity, pain interference, pain-related self-efficacy, patient perception of change, and physician perception of change in pain management) will be measured at baseline, post-intervention and 3-month follow-up. Follow-up interviews with a subsample of 12 participants and 4 physicians will enable us to gain a better understanding of potential treatment benefits, learn about challenges encountered, and obtain suggestions for treatment optimization. This is the first music therapy study to examine the benefits of music therapy for opioid tapering in cancer survivors with chronic pain and the results will be used to establish estimates of variance for sample size calculations for a larger-scale randomized control trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult cancer survivors
  • chronic pain for ≥ 3 months
  • chronic opioid use (i.e., use of opioids for more than 90 days)
  • willingness to reduce the amount of opioids currently taking

排除标准

  • history of polysubstance abuse/substance use disorder
  • currently receiving methadone maintenance or suboxone treatment
  • active psychosis or dementia
  • inability to speak or write English
  • moderate to severe hearing impairment

结局指标

主要结局

Daily opioid dose

时间窗: Through study completion, a maximum of 28 weeks

Taking information from the Prescription Drug Monitoring Program, we will calculate the mean daily opioid dose for each participant by dividing the quantity of opioid pills prescribed by the number of days for which it was supplied.

Self-reported opioid use

时间窗: Through study completion, a maximum of 28 weeks

Self-report on intake of opioids and NSAIDS through daily pain medication log

次要结局

  • Pain interference(At baseline, post-intervention (week 10), and 3-month follow up)
  • Self-efficacy(At baseline, post-intervention (week 10), and 3-month follow up)
  • Pain intensity(At baseline, post-intervention (week 10), and 3-month follow up)
  • Patient perception of change(At post-intervention (week 10) and 3-month follow up)
  • Physician perception of change(At baseline, post-intervention (week 10), and 3-month follow up)
  • Anxiety(At baseline, post-intervention (week 10), and 3-month follow up)
  • Depression(At baseline, post-intervention (week 10), and 3-month follow up)
  • Sleep quality(At baseline, post-intervention (week 10), and 3-month follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joke Bradt

Professor

Drexel University

研究点 (6)

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