CompletedNot Applicable

Meaning-Centered Pain Coping Skills Training for Cancer Pain

United States211 participantsStarted 2023-02-09

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 8-week follow-up

Trial details

NCT IDNCT05385965

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-10

View on ClinicalTrials.gov More Advanced Solid Tumor trials