Clinical trial NCT03661840: Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors
Official title: Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Acceptance and Commitment Therapy
Cancer
Survivor
Group Based
Pain Management
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to the acceptance and commitment therapy intervention or to treatment as usual.
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact]
timeFrame: From baseline to 12 weeks post intervention
measure: The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact]
timeFrame: From baseline to 12 weeks post intervention
Secondary outcomes:
measure: 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
timeFrame: From baseline to end of intervention (weeks 1- 8)
measure: The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability]
timeFrame: From baseline to end of intervention (weeks 1- 8)
measure: The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity]
timeFrame: From baseline to end of intervention (weeks 1- 8)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Elissa Kolva, PhD
role: PRINCIPAL_INVESTIGATOR
References: