Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors

NCT ID: NCT03661840

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-04
• Study Completion Date: 2021-03-04

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Acceptance and Commitment Therapy

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

Group Type: EXPERIMENTAL

Acceptance and Commitment Therapy

Intervention Type: BEHAVIORAL

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.

Treatment as Usual

Treatment as usual will include ongoing provision of usual treatment options for pain management.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elissa Kolva, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

18-1102.cc

Identifier Type: -

Identifier Source: org_study_id