Well-Being After Breast Cancer Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-08

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Coping Skills Training for Persistent Post-Surgical Pain

novel pain coping skills training intervention designed specifically for people with persistent pain (PP) following breast cancer surgery

Group Type EXPERIMENTAL

CST-PSP

Intervention Type BEHAVIORAL

skills training and experiential learning exercises

General health education with a coach

general health education intervention

Group Type ACTIVE_COMPARATOR

General health education

Intervention Type BEHAVIORAL

general health education intervention that focuses on improving overall health

Self-guided health education

general health education intervention

Group Type ACTIVE_COMPARATOR

General health education

Intervention Type BEHAVIORAL

general health education intervention that focuses on improving overall health

Interventions

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CST-PSP

skills training and experiential learning exercises

Intervention Type BEHAVIORAL

General health education

general health education intervention that focuses on improving overall health

Intervention Type BEHAVIORAL

Other Intervention Names

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Coping Skills Training for Persistent Post-Surgical Pain

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No