Well-Being After Breast Cancer Surgery

NCT04225585 | Completed DMC

• 1 other identifier: Pro00104214
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the benefits of skills training and health education interventions designed specifically to increase the well-being of people with persistent pain after breast surgery for lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), or invasive breast cancer, and to examine the roles of psychological and physiological variables as modifiable contributors to the continuing burden of persistent pain.

Conditions

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

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

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

Behavioral: General health education

Interventions

CST-PSP BEHAVIORAL

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 education BEHAVIORAL

general health education intervention that focuses on improving overall health

General health education with a coach; Self-guided health education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• reports score of ≥3 in the past month on the 0 to 10 breast pain severity and/or interference scale
• able to speak and read English
• able to provide meaningful consent

You may not qualify if:

• \<18 years of age
• hearing impairment that limits use of videoconferencing for intervention sessions
• cognitive impairment that is documented in the medical record or results in being unable to provide meaningful consent

Sponsors & Collaborators

• Duke University: lead
• University of Pittsburgh Medical Center: collaborator

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

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: 36152791 DERIVED

Study Officials

• Rebecca Shelby, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Dana Bovbjerg, PhD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

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
• Study Start: June 8, 2021
• Primary Completion: March 11, 2026
• Study Completion: March 11, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)