Trials Sponsors Conditions Drugs Pricing

Conditions

Coping Skills Training for Persistent Post-Surgical Pain General Health Education

Outcome Measures

Primary Outcomes (1)

Change in PEG Pain Severity and Interference
Persistent post-surgical pain burden 3-item measure: average pain intensity (P); interference with enjoyment in life (E); interference with general activity (G)
Baseline, 3 months, 6 months, 12 months

Secondary Outcomes (4)

Change in emotional distress: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
Baseline, 3 months, 6 months, 12 months
Change in pain catastrophizing: Pain Catastrophizing Scale (PCS)
Baseline, 3 months, 6 months, 12 months
Change in Central sensitization: Central Sensitization Inventory (CSI)
Baseline, 3 months, 6 months, 12 months
Change in Central sensitization: Temporal summation
Baseline, 6 months, 12 months

Other Outcomes (5)

Change in cancer-specific distress: Impact of Event Scale (IES)
Baseline, 3 months, 6 months, 12 months
Change in psychological inflexibility: Acceptance and Action Questionnaire (AAQ-II)
Baseline, 3 months, 6 months, 12 months
Change in self-efficacy: Chronic Pain Self-Efficacy Scale: Function Self-Efficacy Subscale (FSE)
Baseline, 3 months, 6 months, 12 months
+2 more other outcomes

Study Arms (3)

Coping Skills Training for Persistent Post-Surgical Pain

EXPERIMENTAL

novel pain coping skills training intervention designed specifically for people with persistent pain (PP) following breast cancer surgery

Behavioral: CST-PSP

General health education with a coach

ACTIVE COMPARATOR

general health education intervention

Behavioral: General health education

Self-guided health education

ACTIVE COMPARATOR

general health education intervention

Interventions

CST-PSPBehavioral

skills training and experiential learning exercises

Also known as: Coping Skills Training for Persistent Post-Surgical Pain

Coping Skills Training for Persistent Post-Surgical Pain

General health educationBehavioral

general health education intervention that focuses on improving overall health

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

prior diagnosis of Stage 0 to III breast cancer, DCIS or LCiS
received first breast cancer surgery (total or partial mastectomy, lumpectomy) at least 3 months ago

Sponsors & Collaborators

University of Pittsburgh Medical Center
Othercollaborator
Duke University
Otherlead

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27705, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Related Publications (1)

Stalls JM, Bovbjerg DH, Somers TJ, Plumb Vilardaga JC, Kimmick GG, McAuliffe PF, Keefe FJ, Posluszny DM, Sullivan MJL, Erkanli A, Reed SD, Sutton L, Owen L, Massa L, Shelby RA. Improving well-being for individuals with persistent pain after surgery for breast cancer, lobular carcinoma in situ, or ductal carcinoma in situ: A randomized clinical trial. Contemp Clin Trials. 2022 Nov;122:106934. doi: 10.1016/j.cct.2022.106934. Epub 2022 Sep 21.
PMID: 36152791DERIVED

Study Officials

Rebecca Shelby, PhD
Duke University
PRINCIPAL INVESTIGATOR
Dana Bovbjerg, PhD
University of Pittsburgh Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

316 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Masking Details: Study staff conducting assessments will be blind to group assignment. To maintain blinding, we will use the following approaches: 1) all study staff will be trained on the importance of blinding and study procedures to maintain blinding; 2) participants will be provided with the rationale and instructions not to disclose their group assignment; 3) the study staff who conduct post-intervention assessments will not be given information about group assignment prior to the assessment; and 4) if a breach occurs, it will be documented and the participant will complete their assessment with a new assessor.
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 13, 2020

Well-Being After Breast Cancer Surgery

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (5)

Study Arms (3)

Coping Skills Training for Persistent Post-Surgical Pain

General health education with a coach

Self-guided health education

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (5)

Study Arms (3)

Coping Skills Training for Persistent Post-Surgical Pain

General health education with a coach

Self-guided health education

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations