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Clinical Trials/NCT03661840
NCT03661840
Completed
Not Applicable

Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors

University of Colorado, Denver1 site in 1 country50 target enrollmentDecember 4, 2018
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
University of Colorado, Denver
Enrollment
50
Locations
1
Primary Endpoint
The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact]
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 4, 2018
End Date
March 4, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

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

Time Frame: From baseline to 12 weeks post intervention

Use the Medical Outcomes Study 36-Item Short Form Health Survey to assess emotional wellbeing. Min=0 Max=100 Higher scores indicate better emotional wellbeing.

Secondary Outcomes

  • 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))

Study Sites (1)

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