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临床试验/NCT03661840
NCT03661840已完成不适用

Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年12月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact]

研究概览

简要总结

A study to help manage chronic pain in cancer survivors through Acceptance and Commitment Therapy (ACT) after undergoing active cancer treatment, such as surgery, chemotherapy, and/or radiation.

详细描述

This study attempts to apply effective pain management interventions from other chronic pain populations to those of cancer related populations. It will assess the ability of ACT to alleviate chronic cancer related pain and evaluate ease of implementation of treatment. Patients will be allocated to either the intervention group (ACT) or the control group, getting them the usual course of treatment.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Provision to sign and date the consent form
  • Stated willingness to comply with all study procedures and be available for the duration of the study
  • Be a male or female aged 18-100
  • Have pathology confirmed diagnosis of a solid tumor cancer
  • Be three or more months out from active cancer treatment (surgery, chemotherapy, and/or radiation)
  • Endorses experiencing pain for three or more months prior to eligibility screening
  • Indicates moderate to severe difficulties with pain interference as related to their cancer experience, with a score of 4 or higher on the pain interference item from the Chronic Pain Grading Questionnaire
  • Shows no evidence of cancer disease (NED) or with stable, chronic disease under "watchful waiting"
  • Fluent in English
  • Psychiatric stability as assessed by chart review and study personnel (e.g., not exhibiting symptoms consistent with diagnoses of serious mental illness such as active psychosis or mania)

排除标准

  • Having pain that can be solely attributed to a diagnosis outside of their cancer experience
  • Presenting with barriers to group participation (e.g., social anxiety) or when group-based provision of care would impede participant's treatment or that of other group members
  • Patients with a diagnosis of malignant neoplasm of the brain (ICD-10 C71) or malignant neoplasm of spinal cord, cranial nerves and other parts of central nervous system (ICD-10 C72).

研究组 & 干预措施

Acceptance and Commitment Therapy

Experimental

Participants will receive both the ACT intervention and medication management that is given as usual treatment.

干预措施: Acceptance and Commitment Therapy (Behavioral)

结局指标

主要结局

The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact]

时间窗: From baseline to 12 weeks post intervention

Use the Medical Outcomes Study 36-Item Short Form Health Survey to assess physical health. Min = 0 Max = 100 Higher scores are better.

次要结局

  • The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability](From baseline to end of intervention (weeks 1- 8))
  • The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity](From baseline to end of intervention (weeks 1- 8))
  • Number of Participants Who Want to Use Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment Active Cancer Treatment(From baseline to end of intervention (weeks 1- 8))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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