Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy; Other: Treatment as Usual

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acceptance and Commitment Therapy; Participants will receive both the ACT intervention and medication management that is given as usual treatment.	Behavioral: Acceptance and Commitment Therapy; Intervention group participants will attend eight weekly, 90-minute, in person, group-based ACT sessions. Groups will be initiated with no more than 10 participants and no fewer than 6 participants. Sessions will include key theoretical ACT constructs and strategies as they relate to chronic pain. A licensed clinical psychologist or licensed clinical social worker trained in ACT will facilitate all sessions. Participants in the ACT intervention group will also continue to receive medication management and other behavioral management interventions that they would get as usual treatment.
Active Comparator: Treatment as Usual; Treatment as usual will include ongoing provision of usual treatment options for pain management.	Other: Treatment as Usual; Treatment as usual will include ongoing provision of usual treatment options for pain management. This includes continued medication management for cancer related chronic pain by prescribing providers, and access to supportive oncology services. It may also include other behavioral pain management such as physical therapy, acupuncture, or massage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact]	Use the Medical Outcomes Study 36-Item Short Form Health Survey to assess physical health. Min = 0 Max = 100 Higher scores are better.	From baseline to 12 weeks post intervention
The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact]	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.	From baseline to 12 weeks post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	From baseline to end of intervention (weeks 1- 8)
The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability]	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).	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]	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.	From baseline to end of intervention (weeks 1- 8)

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Elissa Kolva, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2018
• Primary Completion (Actual): March 4, 2021
• Study Completion (Estimated): January 20, 2025

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy; Cancer; Pain Management; Survivor; Group Based
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 18-1102.cc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No