Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy
* Other: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to the acceptance and commitment therapy intervention or to treatment as usual.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acceptance and Commitment Therapy<br>Participants will receive both the ACT intervention and medication management that is given as usual treatment. | Behavioral: Acceptance and Commitment Therapy<br>* 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.<br>|
| Active Comparator: Treatment as Usual<br>Treatment as usual will include ongoing provision of usual treatment options for pain management. | Other: Treatment as Usual<br>* 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.<br>|

What is the study measuring?
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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. | From baseline to 12 weeks post intervention, over 3 years. | 
| 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. | From baseline to 12 weeks post intervention, over 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The desire for patients to want use Acceptance and Commitment Therapy as a method for treating chronic pain post active cancer treatment: [Feasibility] | Feasibility of the intervention will be assessed through the collection of participant enrollment and adherence data throughout the intervention period and follow-up. | From baseline to 12 weeks post intervention, over 3 years. | 
| The amount of patients who 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 semi-structured qualitative interviews and weekly ratings of acceptability for each session with intervention group members. | From baseline to 12 weeks post intervention, over 3 years. | 
| The ability of methodological strategies used to monitor and enhance the reliability and validity of ACT: [Fidelity] | Fidelity of the treatment will be measured through observation and the use of standardized checklist of core intervention components. | From baseline to 12 weeks post intervention, over 3 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acceptance and Commitment Therapy, Cancer, Survivor, Group Based, Pain Management