Clinical trial NCT04225585: Well-Being After Breast Cancer Surgery
Official title: 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 That Compares Three Behavioral Intervention Strategies and Examines Psychological Factors as Drivers of the Continuing Burden of Persistent Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coping Skills Training for Persistent Post-Surgical Pain
General Health Education
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh Medical Center
First posted: 2020-01-13
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Persistent pain following breast surgery for lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), or invasive breast cancer 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 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 (CST-PSP) and aims to reduce pain catastrophizing, increase self-efficacy for engaging in valued activities, and increase psychological flexibility. We propose a multiple-site, randomized clinical trial to evaluate the efficacy of the CST-PSP intervention, as well as a health education 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=316) will be randomized to either receive: 1) CST-PSP, 2) health education with an interventionist, or 3) self-guided health education . 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 intervention programs 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 intervention programs on pain catastrophizing, pain self-efficacy, and psychological inflexibility, and evaluate these variables as possible mediators of the intervention benefits. Aim 3: Evaluate the impact of intervention programs on pain sensitivity and central sensitization, and explore whether changes in these variables mediate group differences in pain severity and interference.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* \<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

Primary outcomes:
measure: Change in PEG Pain Severity and Interference
timeFrame: Baseline, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Change in emotional distress: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in pain catastrophizing: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in Central sensitization: Central Sensitization Inventory (CSI)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in Central sensitization: Temporal summation
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
measure: Change in cancer-specific distress: Impact of Event Scale (IES)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in psychological inflexibility: Acceptance and Action Questionnaire (AAQ-II)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in self-efficacy: Chronic Pain Self-Efficacy Scale: Function Self-Efficacy Subscale (FSE)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in Pain sensitivity: Pressure pain thresholds
timeFrame: Baseline, 6 months, 12 months
measure: Change in Pain sensitivity: Mechanical cutaneous pain thresholds
timeFrame: Baseline, 6 months, 12 months
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Duke University
name: Rebecca Shelby, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh Medical Center
name: Dana Bovbjerg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.