Meaning-Centered Pain Coping Skills Training for Cancer Pain

Last updated: January 23, 2025
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Treatment

Meaning-Centered Pain Coping Skills Training

Clinical Study ID

NCT05385965
Pro00110762
  • Ages > 18
  • All Genders

Study 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 (N=210) 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 MeasurementInformation System [PROMIS] Pain Interference T-score >/= 55) in the past week attelephone screening

  • Ability to speak and read in English

  • Age >/= 18 years.

Exclusion

Exclusion Criteria:

  • Significant cognitive impairment as indicated in medical chart or during telephonescreening

  • Serious untreated mental illness

  • Primary brain cancer diagnosis

  • Previous engagement in Pain Coping Skills Training or Meaning-Centered Psychotherapy

  • Enrollment in hospice at screening

Study Design

Total Participants: 210
Treatment Group(s): 1
Primary Treatment: Meaning-Centered Pain Coping Skills Training
Phase:
Study Start date:
February 09, 2023
Estimated Completion Date:
March 26, 2026

Study Description

Many patients with advanced cancer describe pain as a debilitating symptom that greatly interferes with activities they care about. Psychosocial interventions show promise for improving cancer-related pain; however, there is a lack of interventions that address existential and spiritual concerns (e.g., a loss of meaning, purpose, and peace) that are common among those facing high levels of pain interference from advanced cancer.

To address this need, an intervention called Meaning-Centered Pain Coping Skills Training (MCPC) was developed. In this trial, the investigators will randomize 210 patients to MCPC or enhanced usual care control. Patient-reported outcomes will be assessed at baseline and 8- and 12-weeks after baseline. As in the investigators' extensive pilot work, MCPC's four 45-to-60 minute individual weekly sessions will be delivered by trained study therapists via an accessible videoconference format. Intervention sessions focus on training participants in evidence-based cognitive-behavioral skills, such as guided imagery and activity pacing. Emphasis is placed on using skills to reduce the degree to which pain interferes with participants' sense of meaning, purpose, and peace.

The first aim of this trial is to determine the efficacy of MCPC for reducing the primary outcome of pain interference at 8-weeks. The second aim is to determine the efficacy of MCPC for improving secondary outcomes at 8-weeks. The third aim is to test the maintenance of MCPC's effects on primary and secondary outcomes at 12-weeks. The fourth aim is to estimate the cost-effectiveness of implementing MCPC.

Connect with a study center

  • Duke Cancer Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

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