Meaning-Centered Pain Coping Skills Training

Study Overview
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Brief Summary
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This study is a randomized clinical trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid tumor cancer and at least moderate pain will be randomized to MCPC or a standard care control condition. Patient-reported outcomes will be assessed at baseline and 5- and 10-week follow-ups. The first aim of this study is to assess the feasibility of conducting a randomized clinical trial to test MCPC. The second aim is to characterize MCPC's effects on patient-reported outcomes of pain severity, pain interference, meaning in life, self-efficacy for pain management, and psychological distress. The third aim is to describe participants' experiences of MCPC using semi-structured qualitative interviews. The risk and safety issues in this trial are low and limited to those common to a psychosocial intervention (e.g., loss of confidentiality).

Detailed Description
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Many patients with advanced cancer describe pain as their most feared and distressing symptom. In this population, higher pain levels often predict worse physical, emotional, and existential/spiritual well-being. Psychosocial interventions show promise for improving cancer-related pain; however, no interventions address existential concerns (e.g., a loss of meaning in life) that are common among those facing pain from advanced illness. To address this need, an intervention called Meaning-Centered Pain Coping Skills Training (MCPC) was developed. MCPC seeks to teach patients cognitive and behavioral skills for managing pain (e.g., guided imagery) in order to help them engage with what gives their life a sense of meaning, purpose, and significance. This pilot study is being conducted to prepare for a large-scale clinical trial that will test the efficacy of MCPC for improving patients' pain and pain-related outcomes.

Official Title
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Meaning-Centered Pain Coping Skills Training: A Randomized Pilot Trial for Patients With Advanced Cancer and Pain

Conditions
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Advanced Solid Tumor, Pain

Intervention / Treatment
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* Behavioral: Meaning-Centered Pain Coping Skills Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage IV solid tumor cancer diagnosis; or stage III pancreatic or lung cancer diagnosis At least moderate pain (worst pain in past week >/= 4 out of 10) at screening Eastern Cooperative Oncology Group (ECOG) performance status </= 2 at screening Ability to speak and read English Exclusion Criteria: Brain tumor diagnosis Significant cognitive impairment Untreated serious mental illness that would interfere with engagement in the interventions (e.g., schizophrenia) Previous engagement in Pain Coping Skills Training or Meaning-Centered Psychotherapy Enrollment in hospice

Ages Eligible for Study
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Minimum Age: 18 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 randomly assigned to an intervention or a standard care control condition.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meaning-Centered Pain Coping Skills Training<br>Four, 45-60 minute, videoconference-delivered sessions focus on training participants in cognitive and behavioral skills (e.g., guided imagery) for managing pain. | Behavioral: Meaning-Centered Pain Coping Skills Training<br>* The goal of this intervention is to help participants manage pain so that they can engage with what gives them a sense of meaning, purpose, and significance in life.<br>|
| No Intervention: Standard Care<br>Information and referrals for free services available through the Duke Cancer Patient Support Program. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as measured by study accrual | Treatment feasibility will be evidenced by meeting study accrual (N = 60). | Baseline | 
| Feasibility as measured by adherence and assessment completion | Treatment feasibility will be evidenced by at least 75% of participants completing all four intervention sessions as well as the 5-week follow-up assessment. | 5-week follow-up (immediately post-intervention) | 
| Feasibility as measured by attrition | Treatment feasibility will be evidenced by no more than 25% attrition by the 5-week follow-up. | 5-week follow-up (immediately post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain severity | Pain severity will be measured using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF consists of 4 items assessing pain severity, including worst, least, average, and current pain. The minimum value on this scale is 0 and the maximum value is 10. Higher scores represent worse outcomes. | Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up | 
| Change in pain interference | Pain interference will be measured using the 6-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form. This measure assesses the degree to which pain has impacted patients' enjoyment of life and engagement in social, cognitive, emotional, physical, and recreational activities. The minimum value on this scale is 6 and the maximum value is 30. Higher scores represent worse outcomes. | Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up | 
| Change in meaning in life | Meaning in life (i.e., purpose, coherence, and significance) and overall spiritual well-being will be measured using the 12-item Functional Assessment of Cancer Therapy - Spiritual Well-Being scale (FACIT-Sp).The minimum value on each subscale is 0 and the maximum value is 4. Higher scores represent better outcomes. | Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up | 
| Change in self-efficacy for pain management | Self-efficacy for pain management will be measured using the Self-efficacy for Pain Management subscale of the Chronic Pain Self-Efficacy Scale. The subscale includes 5 items assessing patients' confidence regarding pain management, managing pain during daily activities, keeping pain from interfering with sleep, and confidence in their ability to reduce pain using methods other than taking additional medication.The minimum value on this scale is 10 and the maximum value is 100. Higher scores represent better outcomes. | Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up | 
| Change in anxiety | Anxiety will be measured using the 7-item version of the Generalized Anxiety Disorders scale (GAD-7), which assesses the frequency of nervousness, worry, difficulty relaxing, restlessness, irritability, and fear. The minimum value on this scale is 0 and the maximum value is 21. Higher scores represent worse outcomes. | Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up | 
| Change in depressive symptoms | Depressive symptoms will be measured using the 8-item version of the Patient Health Questionnaire (PHQ-8), which assesses the frequency of anhedonia, depressed mood, sleep difficulties, lack of energy, appetite disturbance, low self-esteem, trouble concentrating, and psychomotor retardation.The minimum value on this scale is 0 and the maximum value is 24. Higher scores represent worse outcomes. | Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up | 
| Change in hopelessness | Hopelessness will be measured using the Hopelessness Assessment in Illness Questionnaire. The scale includes 8 items assessing the degree to which patients have felt hopelessness, discouragement, and dread. The minimum value on this scale is 0 and the maximum value is 16. Higher scores represent worse outcomes. | Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid Tumor Cancer, Pain, Meaning-Centered Psychotherapy, Pain Coping Skills Training, Meaning-Centered Pain Coping, Advanced Cancer