NCT03207360

Pain Coping Skills and Meaning-Centered Intervention

Completed NA Last updated 13 February 2020

What this trial tests

NA trial testing Pain Coping Skills in Advanced Cancer in 31 participants. Completed in 11 February 2020.

Timeline

17 November 2017

Primary endpoint
11 February 2020

11 February 2020

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	17 November 2017
Primary completion	11 February 2020
Estimated completion	11 February 2020
Sites	1 location across United States

Drugs / interventions tested

• Pain Coping Skills

Conditions studied

• Advanced Cancer — all drugs for Advanced Cancer →
• Pain — all drugs for Pain →

Sponsor

Duke University

Who can join

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

Sponsor's own description

The proposed study seeks to develop and test a novel psychosocial pain management intervention for patients with advanced cancer. It is hypothesized that the intervention will demonstrate feasibility, acceptability, and preliminary efficacy. The first aim is to develop a combined pain coping skills training and meaning-centered psychotherapy intervention. The second aim is to test the intervention's feasibility and acceptability as well as preliminary efficacy for improving primary outcomes (i.e., pain, pain interference, and meaning in life) and secondary outcomes. Two efficacious, theory-driven interventions will be integrated to address pain management by teaching pain coping skills with a novel emphasis on enhancing a sense of meaning in life. Participants will be patients with advanced cancer and moderate-to-severe pain. The study will be conducted in two phases. Phase I of the study will be intervention development. The intervention content will be guided by theory and mentoring from a team of leading experts in pain management and meaning-centered psychotherapy. Initial intervention content will be further informed by interviews with patients with advanced cancer. Content will then be refined through an iterative patient testing process. Phase II of the study will be a single-arm pilot trial testing the intervention. The intervention will be delivered in-person and consist of four, 45-to-60 minute therapy sessions delivered using videoconferencing technology. Study measures will be collected at baseline (0 weeks), immediately post-intervention (5 weeks), and 4-weeks post-intervention (9 weeks).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Meaning-Centered Pain Coping Skills Training: A Pilot Feasibility Trial of a Psychosocial Pain Management Intervention for Patients with Advanced Cancer.
   Winger JG, Ramos K, Kelleher SA, Somers TJ, et al · · 2022 · cited 18× · PMID 34388037 · DOI 10.1089/jpm.2021.0081