Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors

Chronic Pain Clinical Trial

Official title:

Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03661840
• Other study ID #: 18-1102.cc
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: January 20, 2025

Study information

• Verified date: February 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 20, 2025
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)