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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 belowSelect...
I have experienced pain rated above 0 in the past month.
Select...
I am 18 years old or older.
Select...
I am 18 years old or older.
Select...
I can walk and take care of myself, but I can't do heavy physical work.
Select...
My cancer is at stage IV.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.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)
+6 moreOther study objectives
All-cause medical resource use
Participant productivity
Participant time
+1 moreAwards & 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
Find a Location
Who is running the clinical trial?
American Cancer Society, Inc.OTHER
233 Previous Clinical Trials
109,601 Total Patients Enrolled
3 Trials studying Pain
133 Patients Enrolled for Pain
Duke UniversityLead Sponsor
2,462 Previous Clinical Trials
2,968,710 Total Patients Enrolled
25 Trials studying Pain
8,694 Patients Enrolled for Pain
Joseph G Winger, PhDPrincipal InvestigatorDuke University
2 Previous Clinical Trials
91 Total Patients Enrolled
2 Trials studying Pain
91 Patients Enrolled for Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with primary brain cancer.I have participated in pain coping or meaning-centered therapy before.I have experienced pain rated above 0 in the past month.I am 18 years old or older.I am 18 years old or older.I can walk and take care of myself, but I can't do heavy physical work.My cancer is at stage IV.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Care
- Group 2: Meaning-Centered Pain Coping Skills Training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.