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Behavioral Intervention

Meaning-Centered Coping Skills Training for Cancer Pain (MCPC Trial)

N/A

Recruiting

Led By Joseph G Winger, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least one clinical pain severity rating > 0 out of 10 in past month

Age >/= 18 years.

Must not have

Primary brain cancer diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8-week follow-up and 12-week follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trialstudies a psychosocial pain management intervention for people with advanced cancer & pain interference. Outcomes will be assessed at 3 points. Risk/safety is low & limited to a psychosocial intervention.

Who is the study for?

This trial is for English-speaking adults over 18 with advanced solid tumor cancer and pain. They must have a performance status that allows daily activity (ECOG ≤2) and have experienced pain recently. It's not for those with significant cognitive issues, untreated serious mental illness, brain cancer, previous similar therapy experience, or in hospice care.

What is being tested?

The study tests Meaning-Centered Pain Coping Skills Training (MCPC), comparing it to standard care in patients with advanced cancer-related pain. Participants are randomly assigned to either the MCPC program or regular treatment and followed up at 8 and 12 weeks.

What are the potential side effects?

Risks associated with this psychosocial intervention are minimal but may include loss of confidentiality due to the personal nature of sharing during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have experienced pain rated above 0 in the past month.

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I am 18 years old or older.

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I am 18 years old or older.

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I can walk and take care of myself, but I can't do heavy physical work.

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My cancer is at stage IV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with primary brain cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8-week follow-up and 12-week follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8-week follow-up and 12-week follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-week follow-up and 12-week follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

5-item 5-level EuroQol Group (EQ-5D-5L)

Brief Pain Inventory-Short Form (BPI-SF) Pain Severity Subscale

Chronic Pain Self-Efficacy Scale (CPS)

+5 more

Other study objectives

All-cause medical resource use

Participant productivity

Participant time

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Meaning-Centered Pain Coping Skills TrainingExperimental Treatment1 Intervention

Four, 45-60 minute, videoconference-delivered sessions focus on training participants in cognitive and behavioral skills (e.g., guided imagery, activity pacing) for managing pain.

Group II: Standard CareActive Control1 Intervention

Information and referrals for free services available through the Duke Cancer Patient Support Program.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Meaning-Centered Pain Coping Skills Training

2021

N/A

~60

0 / 6Eligibility criteria met