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Well-Being After Breast Cancer Surgery: Targeted-PCST for Persistent Post-Mastectomy Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04225585
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : June 24, 2021
Sponsor:
Collaborator:
University of Pittsburgh Medical Center
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of this study is to test a skills training program to help with coping skills for pain that was designed specifically for women with persistent pain after breast cancer surgery.

Condition or disease Intervention/treatment Phase
Targeted Pain Coping Skills Training General Health Education Enhanced Usual Care Behavioral: Targeted-PCST Behavioral: General health education Not Applicable

Detailed Description:
Persistent pain following breast cancer surgery is increasingly recognized as an important clinical and public health issue due to the large number of women affected, the powerful negative impact that persistent pain has on emotional and physical functioning and its financial costs. Most of the more than a quarter of a million women newly diagnosed with breast cancer in the U.S. this year will undergo surgery as a part of curative treatment. The prevalence of persistent pain following surgical removal of the affected breast (mastectomy) or more limited surgeries (lumpectomy) is high, ranging from 25-60% across studies. Unlike acute post-operative pain, which is a normal response to surgical trauma, persistent pain at or near the surgical site has an uncertain multifaceted etiology, and no satisfactory pharmacological treatment. A critical question is whether key pain-related psychosocial factors are drivers of the continuing burden of persistent pain, and whether they could be ameliorated by non-pharmacological intervention. The research planned under this award will provide a first critical test of the hypothesized driving role of pain catastrophizing in persistent pain after breast cancer surgery. It also will explore the role of two other key psychosocial variables that may contribute to the burden associated with persistent pain after breast cancer surgery: self-efficacy for engaging in valued activities and psychological inflexibility. We have developed, manualized, and pilot tested a pain coping skills training intervention that specifically targets the needs of women with persistent pain following breast cancer surgery (Targeted PCST) and aims to reduce pain catastrophizing, increase self-efficacy for engaging in valued activities, and decrease psychological inflexibility. We propose a multiple-site, randomized clinical trial to evaluate the efficacy of the Targeted-PCST intervention. The study will be conducted in diverse oncology clinics affiliated with Duke University/Duke Cancer Network and the University of Pittsburgh/UPMC Hillman Cancer Center. Participants (N=564) will be randomized to either receive: 1) Targeted-PCST, 2) a general health education intervention (control), or 3) enhanced usual care (control). Participants will complete assessments pre-intervention and at 3 months (post-intervention), 6 months follow-up, and 12 months follow-up. Study aims are: Aim 1: Examine the impact of Targeted-PCST on persistent post-surgical pain severity and interference (i.e., PEG score), emotional distress (anxiety and depression), and cancer-specific distress. Aim 2: Investigate the impact of Targeted-PCST on pain catastrophizing, pain self-efficacy, and psychological inflexibility, and evaluate these variables as possible mediators of the benefits of Targeted-PCST. Aim 3: Evaluate the impact of Targeted-PCST on pain sensitivity and central sensitization, and explore whether changes in these variables mediate group differences in pain severity and interference.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Persistent Post-Mastectomy Pain: Randomized Clinical Trial of Targeted Pain Coping Skills Training (Targeted-PCST) With Mediational Analysis
Actual Study Start Date : June 8, 2021
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Experimental: Targeted Pain Coping Skills Training (Targeted-PCST)
novel pain coping skills training intervention designed specifically for women with persistent pain (PP) following breast cancer surgery (active intervention group)
Behavioral: Targeted-PCST
skills training and experiential learning exercises
Other Name: Targeted Pain Coping Skills Training

Placebo Comparator: General health education
general health education Intervention (control group)
Behavioral: General health education
general health education intervention that focuses on improving overall health

No Intervention: Self-guided health education
usual health care and usual medical treatment for pain



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


Secondary Outcome Measures :
  1. Patient Health Questionnaire Depression Screener (PHQ-9) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    9-item assessment of depressive symptoms over the past two weeks

  2. Impact of Event Scale (IES) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    15-item measure of intrusive and avoidant cognition regarding breast cancer during the past week

  3. Pain Catastrophizing Scale (PCS) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    13-item assessment of the degree to which participants experience catastrophic thinking during painful experiences

  4. Acceptance and Action Questionnaire (AAQ-II) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    7-item questionnaire designed to measure psychological inflexibility

  5. Central Sensitization Inventory (CSI) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    25-item questionnaire designed to measure hypersensitivity to senses and signs of central sensitization

  6. Pain sensitivity: Pressure pain thresholds [ Time Frame: Baseline, 6 months, 12 months ]
    Designed to measure central hyperexcitability using a digital pressure algometer measured pressure that is first perceived as painful and recorded in kg

  7. Central sensitization: Temporal summation [ Time Frame: Baseline, 6 months, 12 months ]
    Designed to measure central pain mediation using weighted pinprick probes

  8. Generalized Anxiety Disorder Screener (GAD-7) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    7-item assessment of symptoms of anxiety over the past two weeks

  9. Chronic Pain Self-Efficacy Scale: Function Self-Efficacy Subscale (FSE) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    9-item questionnaire designed to measure chronic pain patients' perceived self-efficacy for engaging in activities


Other Outcome Measures:
  1. Patient Healthcare Utilization [ Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, 12 months ]
    6-item self-report of time spent utilizing healthcare in the past 4 weeks, as well as medication use and time spent on the intervention

  2. Five-level EuroQoL-5 Dimensions (5L EQ-5D) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
    5-item assessment of current health utility, plus 0 to 100 rating of overall health; QALYS will be derived from utility estimates



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • prior diagnosis of Stage 0 to III breast cancer
  • received first breast cancer surgery (total or partial mastectomy, lumpectomy) in the past 3 to 12 months
  • reports average breast pain of ≥3 in the past month on the 0 to 10 pain severity scale
  • able to speak and read English
  • able to provide meaningful consent

Exclusion Criteria:

  • <18 years of age
  • history of prior breast surgery
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04225585


Contacts
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Contact: Rebecca Shelby, PhD 919-416-3410 rebecca.shelby@duke.edu
Contact: Dana Bovbjerg, PhD 412-623-5965 bovbjergdh@upmc.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Rebecca Shelby, PhD    919-416-3410    rebecca.shelby@duke.edu   
Principal Investigator: Rebecca Shelby, PhD         
United States, Pennsylvania
University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Dana Bovbjerg, PhD    412-623-5965    bovbjergdh@upmc.edu   
Principal Investigator: Dana Bovbjerg, PhD         
Sponsors and Collaborators
Duke University
University of Pittsburgh Medical Center
Investigators
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Principal Investigator: Rebecca Shelby, PhD Duke University
Principal Investigator: Dana Bovbjerg, PhD University of Pittsburgh Medical Center
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04225585    
Other Study ID Numbers: Pro00104214
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: June 24, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No