Meaning-Centered Pain Coping Skills Training

Duke University

Status: Completed

Conditions: Advanced Solid Tumor; Pain

Treatments: Behavioral: Meaning-Centered Pain Coping Skills Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04431830

Pro00105953

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Meaning-Centered Pain Coping Skills Training

Experimental group

Description:

Four, 45-60 minute, videoconference-delivered sessions focus on training participants in cognitive and behavioral skills (e.g., guided imagery) for managing pain.

Treatment:

Behavioral: Meaning-Centered Pain Coping Skills Training

Standard Care

No Intervention group

Description:

Information and referrals for free services available through the Duke Cancer Patient Support Program.