Meaning-Centered Pain Coping Skills Training for Cancer Pain

NCT05385965 | Active Not Recruiting DMC

• 1 other identifier: Pro00110762
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid tumor cancer and pain interference will be randomized to MCPC or a standard care control condition. Patient-reported outcomes will be assessed at baseline and 8- and 12-week follow-ups. 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

Caner pain management; Psychosocial intervention; Spiritual aspects of coping with pain; Pain Coping Skills Training; Meaning-Centered Psychotherapy

Outcome Measures

Primary Outcomes (1)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form

  This 8-item measure assesses the degree to which, over the past 7 days, pain has interfered with daily activities, work around the home, engagement in social activities, household chores, fun activities, enjoyment of social activities, enjoyment of life, and family life. Response options range from 1 (not at all) to 5 (very much). Higher scores indicate worse pain interference.

  8-week follow-up

Secondary Outcomes (9)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form

  12-week follow-up

• Brief Pain Inventory-Short Form (BPI-SF) Pain Severity Subscale

  8-week follow-up and 12-week follow-up

• Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp)

  8-week follow-up and 12-week follow-up

• Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose Scale

  8-week follow-up and 12-week follow-up

• Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-Short Form

  8-week follow-up and 12-week follow-up

Other Outcomes (4)

• All-cause medical resource use

  Baseline, 8-week follow-up, and 12-week follow-up

• Participant time

  8-week follow-up

• Participant productivity

  Baseline, 8-week follow-up, and 12-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, activity pacing) 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 reduce pain interference so that they can engage with what gives them a sense of meaning, purpose, and peace.

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
• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
• At least one clinical pain severity rating \> 0 out of 10 in past month
• At least moderate pain interference (8-item Patient-Reported Outcomes Measurement Information System \[PROMIS\] Pain Interference T-score \>/= 55) in the past week at telephone screening
• Ability to speak and read in English
• Age \>/= 18 years.

You may not qualify if:

• Significant cognitive impairment as indicated in medical chart or during telephone screening
• Serious untreated mental illness
• Primary brain cancer diagnosis
• Previous engagement in Pain Coping Skills Training or Meaning-Centered Psychotherapy
• Enrollment in hospice at screening

Sponsors & Collaborators

• Duke University: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

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 with equal allocation to an intervention or a standard care control condition, using a stratified block randomization scheme to ensure group balance based on patient performance status (i.e., Eastern Cooperative Oncology Group \[ECOG\] score of 0 vs. 1 or 2) and pain interference (i.e., Patient-Reported Outcomes Measurement Information System \[PROMIS\] Pain Interference 8-item raw score of 25 or lower vs. 26 or higher) at screening.

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 23, 2022
• Study Start: February 9, 2023
• Primary Completion: April 10, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)