Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors

NCT03661840 | Completed Results DMC

• 1 other identifier: 18-1102.cc
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Acceptance and Commitment Therapy; Cancer; Survivor; Group Based; Pain Management

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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)

• 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)

Study Arms (2)

Acceptance and Commitment Therapy

EXPERIMENTAL

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

Behavioral: Acceptance and Commitment Therapy

Treatment as Usual

ACTIVE COMPARATOR

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

Other: Treatment as Usual

Interventions

Acceptance and Commitment Therapy 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.

Acceptance and Commitment Therapy

Treatment as Usual 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.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Chronic Pain; Neoplasms; Agnosia

Interventions

Acceptance and Commitment Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Elissa Kolva, MD
• Organization: University of Colorado Hospital

elissa.kolva@va.gov

7208488090

Study Officials

• Elissa Kolva, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to the acceptance and commitment therapy intervention or to treatment as usual.

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 7, 2018
• Study Start: December 4, 2018
• Primary Completion: March 4, 2021
• Study Completion: March 4, 2021
• Last Updated: March 13, 2025
• Results First Posted: January 3, 2024

Record last verified: 2025-03

Locations

US (1)