跳至主要内容
临床试验/NCT03752268
NCT03752268Unknown不适用

Development of an Intervention to Enhance Cancer Pain Management

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年4月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
Number of participants who identify study components as acceptable

研究概览

简要总结

This research study is being done to understand how patients with chronic cancer pain take their long-acting opioid medications, and to develop an intervention to enhance cancer pain management.

详细描述

Long-acting opioids are a common treatment for cancer pain. The purpose of this study is to develop a program for patients who are taking a prescribed long-acting opioid for their cancer pain. Participants will be enrolled in this study at the Massachusetts General Hospital Cancer Center. This 14-week study involves completing a set of questionnaires at three different times during the study period. . During the study period, participants will use electronic pill caps to monitor their pain medication taking. They also will attend a series of three visits with one of the nurse practitioners on their care cancer team. The visits will focus on learning and practicing skills for managing cancer pain. The information that the investigators collect will help identify whether the sessions are feasible and useful to patients during the course of treatment for cancer pain.

This trial will consist of two parts:

Part 1: This is a single-group prospective observational study. Investigators will use quantitative and qualitative methods to examine rates, predictors and outcomes of adherence to LA opioids over a period of approximately eight weeks. This information will be used to inform Part 2 intervention development and testing.

Part 2: Investigators will test the behavioral intervention in a non-randomized open pilot, over a period of approximately six weeks. Intervention process data, psychosocial and medical data, and post-intervention feedback will be collected to assess feasibility and acceptability. In an iterative process, ongoing data from exit interviews and therapist experience will be used to modify the intervention protocol.

研究设计

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

入排标准

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

入选标准

  • Age 21 or older
  • Currently prescribed a long-acting (LA) opioid for nociceptive cancer pain (extended release oxycodone, extended-release morphine, transdermal fentanyl patches, methadone tablets)
  • Ability to comprehend study materials in English
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • In charge of administering own pain medications
  • Part 2 study only: within 4 months of current prescription of LA opioid for nociceptive cancer pain

排除标准

  • Impaired cognition, active substance disorder, or other active, unstable mental health disorder
  • Current long-acting opioid treatment for pre-existing condition
  • Part 2 study only: Prior enrollment in the Part 1 study**

结局指标

主要结局

Number of participants who identify study components as acceptable

时间窗: 2 years

Individual response frequencies of 4 Likert-type scale items, designed for this study, that rate acceptability of 1) number of study sessions, 2) length of study sessions, 3) usefulness of study material, and 4) impact of study material on pain management, and themes of two free-text items that elicit unstructured participant feedback about acceptability of these study components.

Number of participants who complete study sessions

时间窗: 2 Years

Proportion of enrolled participants who complete the study, based on a criterion of greater than or equal to 75% completed sessions.

次要结局

未报告次要终点

研究者

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

Lara Traeger

Principal Investigator

Massachusetts General Hospital

研究点 (2)

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