Preventing Persistent Pain and Reducing Depressive and Anxious Symptoms Following Mastectomy and Lumpectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Persistent Postsurgical Pain
- Sponsor
- Katherine Hadlandsmyth
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Numeric Rating Scale
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The proposed study will be a pilot randomized controlled trial comparing treatment as usual (TAU) to treatment as usual plus a brief Acceptance and Commitment Therapy (ACT) intervention (TAU + ACT) with mastectomy and lumpectomy patients identified as at-risk for developing persistent post-operative pain. The ACT intervention is a single individual therapy session scheduled two weeks following surgery. Potential participants will be recruited from the University of Iowa Breast Cancer Clinic. A sample size of n = 30 for each arm will be recruited. An attrition rate of 20% is anticipated so the total N to be recruited for the study is 72 participants. Study measures will consist of self-report questionnaires and medical record data. Data will be collected prior to surgery, one-week after surgery, and 3 months after surgery.
Detailed Description
Psychological interventions addressing depression, anxiety, and psychological approaches to pain management in pre-surgical patients may serve to prevent the development of persistent post-surgical pain, depression, and anxiety in at-risk individuals. Acceptance and Commitment Therapy (ACT) is a psychological therapy that has been shown to be effective in minimizing the impairing impact of chronic pain and in treating depression and anxiety. ACT is a behavior therapy incorporating mindfulness, which aims to increase psychological flexibility via facilitating psychological acceptance and committed action in the direction of one's personally identified values. ACT has also shown promise in brief interventions, including a one day ACT workshop with patients with comorbid migraine and depression. The current study proposes to identify pre-operative breast cancer patients who are at increased risk for developing persistent post-surgical pain and to offer a brief ACT intervention with the aim of reducing the incidence of persistence post-surgical pain and psychological sequela.
Investigators
Katherine Hadlandsmyth
Clinical Assistant Professor of Anesthesia - Chronic Pain Medicine
University of Iowa
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •language or cognitive barriers preventing completion of questionnaires, 2) severe psychiatric disorder: bipolar or psychotic disorder, 3) significant surgical complications.
Outcomes
Primary Outcomes
Numeric Rating Scale
Time Frame: 3-months following surgery
Surgical site pain severity (0 = no pain - 10 = pain as bad as you can imagine)
Secondary Outcomes
- The Brief Pain Inventory (BPI: pain severity)(3-months following surgery)
- Chronic Pain Acceptance Questionnaire(3-months following surgery)
- The Brief Pain Inventory (BPI: pain interference)(3-months following surgery)
- Generalized Anxiety Disorder 7-item scale(3-months following surgery)
- Pain catastrophizing Scale(3-months following surgery)
- Patient Health Questionnaire -8 item(3-months following surgery)
- SF-12 Health Survey(3-months following surgery)