MedPath

Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors

Not Applicable
Completed
Conditions
Chronic Pain
Interventions
Behavioral: Acceptance and Commitment Therapy
Other: Treatment as Usual
Registration Number
NCT03661840
Lead Sponsor
University of Colorado, Denver
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
Inclusion Criteria
  1. Provision to sign and date the consent form
  2. Stated willingness to comply with all study procedures and be available for the duration of the study
  3. Be a male or female aged 18-100
  4. Have pathology confirmed diagnosis of a solid tumor cancer
  5. Be three or more months out from active cancer treatment (surgery, chemotherapy, and/or radiation)
  6. Endorses experiencing pain for three or more months prior to eligibility screening
  7. 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
  8. Shows no evidence of cancer disease (NED) or with stable, chronic disease under "watchful waiting"
  9. Fluent in English
  10. 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
  1. Having pain that can be solely attributed to a diagnosis outside of their cancer experience
  2. 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
  3. 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).

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Acceptance and Commitment TherapyAcceptance and Commitment TherapyParticipants will receive both the ACT intervention and medication management that is given as usual treatment.
Treatment as UsualTreatment as UsualTreatment as usual will include ongoing provision of usual treatment options for pain management.
Primary Outcome Measures
NameTimeMethod
The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact]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 Outcome Measures
NameTimeMethod
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)

Acceptability of the intervention will be assessed through weekly ratings using a 5-point Likert scale for each session with intervention group members. The mean score is reported.

Min = 1, Max = 5. Higher scores are better (i.e., indicate greater acceptability of the intervention).

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)

Fidelity of the treatment will be assessed through the use of a standardized checklist of core intervention components. It is measured as the mean percent of content checklist items presented to groups each week.

Number of Participants Who Want to Use Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment Active Cancer TreatmentFrom baseline to end of intervention (weeks 1- 8)

Feasibility of the intervention will be assessed through the collection of participant enrollment and adherence data throughout the intervention period and follow-up.

We report the count of participants at each therapy session. Therapy sessions were held from baseline through week 8.

Trial Locations

Locations (1)

University of Colorado Hospital

🇺🇸

Aurora, Colorado, United States

© Copyright 2025. All Rights Reserved by MedPath