NCT04431830

Meaning-Centered Pain Coping Skills Training

Completed NA Last updated 4 May 2022

What this trial tests

NA trial testing Meaning-Centered Pain Coping Skills Training in Advanced Solid Tumor in 60 participants. Completed in 3 May 2022.

Timeline

9 February 2021

Primary endpoint
31 March 2022

3 May 2022

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	60
Start date	9 February 2021
Primary completion	31 March 2022
Estimated completion	3 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Meaning-Centered Pain Coping Skills Training

Conditions studied

• Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
• Pain — all drugs for Pain →

Sponsor

Duke University

Who can join

18 and older, any sex, with Advanced Solid Tumor or Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Meaning-centered pain coping skills training for patients with metastatic cancer: Results of a randomized controlled pilot trial.
   Winger JG, Kelleher SA, Ramos K, Check DK, et al · · 2023 · cited 19× · PMID 37173865 · DOI 10.1002/pon.6151
2. Designing Psychosocial Intervention Pilot Studies: A Tutorial for Palliative Care Investigators.
   Winger JG, Kelleher SA, Fisher HM, Somers TJ, et al · · 2022 · cited 7× · PMID 35235856 · DOI 10.1016/j.jpainsymman.2022.02.338