Clinical trial NCT04431830: Meaning-Centered Pain Coping Skills Training
Official title: Meaning-Centered Pain Coping Skills Training: A Randomized Pilot Trial for Patients With Advanced Cancer and Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Solid Tumor
Pain
Keywords: Solid Tumor Cancer
Pain
Meaning-Centered Psychotherapy
Pain Coping Skills Training
Meaning-Centered Pain Coping
Advanced Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2020-06-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to an intervention or a standard care control condition.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility as measured by study accrual
timeFrame: Baseline
measure: Feasibility as measured by adherence and assessment completion
timeFrame: 5-week follow-up (immediately post-intervention)
measure: Feasibility as measured by attrition
timeFrame: 5-week follow-up (immediately post-intervention)
Secondary outcomes:
measure: Change in pain severity
timeFrame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
measure: Change in pain interference
timeFrame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
measure: Change in meaning in life
timeFrame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
measure: Change in self-efficacy for pain management
timeFrame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
measure: Change in anxiety
timeFrame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
measure: Change in depressive symptoms
timeFrame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
measure: Change in hopelessness
timeFrame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Joseph G Winger, PhD
role: PRINCIPAL_INVESTIGATOR
References: