Meaning-Centered Pain Coping Skills Training

NCT ID: NCT04431830

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-09
• Study Completion Date: 2022-05-03

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.

Conditions

Advanced Solid Tumor; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Meaning-Centered Pain Coping Skills Training

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

Group Type: EXPERIMENTAL

Meaning-Centered Pain Coping Skills Training

Intervention Type: BEHAVIORAL

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.

Standard Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Meaning-Centered Pain Coping Skills Training

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph G Winger, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

Winger JG, Kelleher SA, Ramos K, Check DK, Yu JA, Powell VD, Lerebours R, Olsen MK, Keefe FJ, Steinhauser KE, Porter LS, Breitbart WS, Somers TJ. Meaning-centered pain coping skills training for patients with metastatic cancer: Results of a randomized controlled pilot trial. Psychooncology. 2023 Jul;32(7):1096-1105. doi: 10.1002/pon.6151. Epub 2023 May 12.

Reference Type: DERIVED

PMID: 37173865 (View on PubMed)

Other Identifiers

Pro00105953

Identifier Type: -

Identifier Source: org_study_id