Pain Coping Skills and Meaning-Centered Intervention

Completed · Not applicable

Conditions studied: Advanced Cancer, Pain

In brief

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).

Key facts

Study ID

NCT03207360

Run by

Duke University

People needed

31

Starts

2017-11-17

Expected to finish

2020-02-11

Last updated by the study team

2020-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stage IV solid tumor cancer diagnosis; or stage III pancreatic or lung cancer diagnosis
• At least moderate pain (pain score >/= 4) at recruitment
• Clinically elevated distress (NCCN Distress Thermometer >/= 3) at recruitment
• Eastern Cooperative Oncology Group (ECOG) </= 2 at recruitment
• Ability to speak and read English

You may not qualify if…

• Brain tumor diagnosis
• Significant cognitive impairment
• Serious mental illness that would interfere with engagement in the intervention (e.g., schizophrenia)

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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