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Health Education & Coping Skills Training for Postoperative Pain After Breast Cancer Surgery (WB ABCs Trial)
N/A
Recruiting
Led By Rebecca Shelby, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior diagnosis of Stage 0 to III breast cancer, DCIS or LCiS
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, 12 months
Awards & highlights
WB ABCs Trial Summary
This trial will compare the benefits of two interventions to increase well-being in people with persistent pain after breast surgery for breast cancer.
Who is the study for?
This trial is for adults who had breast cancer surgery at least 3 months ago and are experiencing persistent pain. Participants must have been diagnosed with Stage 0 to III breast cancer, DCIS or LCIS, can speak English, and provide consent. It's not for those under 18, with hearing issues that affect videoconferencing use, or cognitive impairments.Check my eligibility
What is being tested?
The study compares the effectiveness of coping skills training (CST-PSP) versus general health education in improving well-being among individuals with ongoing pain after breast cancer surgery. The impact of psychological and physiological factors on persistent pain will also be evaluated.See study design
What are the potential side effects?
Since this trial focuses on educational interventions rather than medications, traditional side effects like those seen with drugs are not expected. However, participants may experience emotional discomfort discussing their condition.
WB ABCs Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was previously diagnosed with early-stage breast cancer.
WB ABCs Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in PEG Pain Severity and Interference
Secondary outcome measures
Acceptance and Action Questionnaire (AAQ-II)
Central Sensitization Inventory (CSI)
Central sensitization: Temporal summation
+6 moreOther outcome measures
Five-level EuroQoL-5 Dimensions (5L EQ-5D)
Patient Healthcare Utilization
WB ABCs Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Coping Skills Training for Persistent Post-Surgical PainExperimental Treatment1 Intervention
novel pain coping skills training intervention designed specifically for people with persistent pain (PP) following breast cancer surgery
Group II: Self-guided health educationActive Control1 Intervention
general health education intervention
Group III: General health education with a coachActive Control1 Intervention
general health education intervention
Find a Location
Who is running the clinical trial?
University of Pittsburgh Medical CenterOTHER
70 Previous Clinical Trials
75,943 Total Patients Enrolled
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,179 Total Patients Enrolled
Rebecca Shelby, PhDPrincipal InvestigatorDuke University
3 Previous Clinical Trials
340 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I was previously diagnosed with early-stage breast cancer.I had my first breast cancer surgery over 3 months ago.You have trouble hearing that makes it hard for you to use video calls for the study sessions.I have a cognitive condition that prevents me from understanding consent forms.You have experienced significant breast pain in the past month, scoring 3 or higher on a scale from 0 to 10.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Coping Skills Training for Persistent Post-Surgical Pain
- Group 2: Self-guided health education
- Group 3: General health education with a coach
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still positions available in this trial?
"Indeed, the research is currently enrolling patients. Its information was initially published on June 8th 2021 and last updated on June 22nd 2022 - as evidenced by clinicaltrials.gov."
Answered by AI
How many participants are currently enrolled in this research program?
"Affirmative. The information accessible through clinicaltrials.gov indicates that this investigation is actively recruiting participants after being first posted on June 8th 2021 and last revised on June 22nd 2022. It currently requires 564 patients to be recruited from 2 medical centres."
Answered by AI
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