Meaning-Centered Pain Coping Skills Training

Duke University60 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Feasibility as measured by study accrual

Treatment feasibility will be evidenced by meeting study accrual (N = 60).

Time frame: 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.

Time frame: 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.

Time frame: 5-week follow-up (immediately post-intervention)

Secondary Outcomes

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.