Coping Skills Training for Persistent Post-Surgical Pain, General Health Education
Conditions
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.
Interventions
BEHAVIORALCST-PSP
skills training and experiential learning exercises
BEHAVIORALGeneral health education
general health education intervention that focuses on improving overall health
Sponsors
Duke University
University of Pittsburgh Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PEG Pain Severity and Interference | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in emotional distress: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) | Baseline, 3 months, 6 months, 12 months | Composite score of 8-item assessment of depressive symptoms over the past two weeks and 7-item assessment of symptoms of anxiety over the past two weeks |
| Change in pain catastrophizing: Pain Catastrophizing Scale (PCS) | Baseline, 3 months, 6 months, 12 months | 13-item assessment of the degree to which participants experience catastrophic thinking during painful experiences |
| Change in Central sensitization: Central Sensitization Inventory (CSI) | Baseline, 3 months, 6 months, 12 months | 25-item questionnaire designed to measure hypersensitivity to senses and signs of central sensitization |
| Change in Central sensitization: Temporal summation | Baseline, 6 months, 12 months | Designed to measure central pain mediation using weighted pinprick probes |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRebecca Shelby, PhD
Duke University
PRINCIPAL_INVESTIGATORDana Bovbjerg, PhD
University of Pittsburgh Medical Center
Outcome results
None listed