Breast Cancer Clinical Trial

Well-Being After Breast Cancer Surgery

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.

View Full Description

Full 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=564) 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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

564

Study ID:

NCT04225585

Recruitment Status:

Recruiting

Sponsor:

Duke University

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 2 Locations for this study

See Locations Near You

Duke University Medical Center
Durham North Carolina, 27705, United States More Info
Rebecca Shelby, PhD
Contact
919-416-3410
[email protected]
Rebecca Shelby, PhD
Principal Investigator
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States More Info
Dana Bovbjerg, PhD
Contact
412-623-5965
[email protected]
Dana Bovbjerg, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

564

Study ID:

NCT04225585

Recruitment Status:

Recruiting

Sponsor:


Duke University

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider