Meaning-Centered Pain Coping Skills Training

NCT04431830 | Completed

• 1 other identifier: Pro00105953
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Advanced Solid Tumor; Pain

Keywords

Solid Tumor Cancer; Pain; Meaning-Centered Psychotherapy; Pain Coping Skills Training; Meaning-Centered Pain Coping; Advanced Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Change in pain severity

  Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

• Change in pain interference

  Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

• Change in meaning in life

  Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

• Change in self-efficacy for pain management

  Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

• Change in anxiety

  Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

Study Arms (2)

Meaning-Centered Pain Coping Skills Training

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

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

Interventions

Meaning-Centered Pain Coping Skills Training 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.

Meaning-Centered Pain Coping Skills Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• 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.

  PMID: 37173865 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph G Winger, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to an intervention or a standard care control condition.

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: February 9, 2021
• Primary Completion: March 31, 2022
• Study Completion: May 3, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)