Preventing Persistent Pain and Reducing Depressive and Anxious Symptoms Following Mastectomy and Lumpectomy
- Conditions
- Breast Cancer FemalePersistent Postsurgical PainDuctal Carcinoma in Situ
- Interventions
- Behavioral: Acceptance and Commitment Therapy
- Registration Number
- NCT03430765
- Lead Sponsor
- Katherine Hadlandsmyth
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 62
Not provided
- language or cognitive barriers preventing completion of questionnaires, 2) severe psychiatric disorder: bipolar or psychotic disorder, 3) significant surgical complications.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acceptance and Commitment Therapy Acceptance and Commitment Therapy Standard breast cancer treatment plus a single 2 hour individual Acceptance and Commitment Therapy coping skills session.
- Primary Outcome Measures
Name Time Method Numeric Rating Scale 3-months following surgery Surgical site pain severity (0 = no pain - 10 = pain as bad as you can imagine)
- Secondary Outcome Measures
Name Time Method The Brief Pain Inventory (BPI: pain severity) 3-months following surgery Pain severity: four items: Average pain, worst in 24 hours, least in 24 hours, and right now (on a 0-10 scale)
Chronic Pain Acceptance Questionnaire 3-months following surgery Pain Acceptance: This 20 item scale has two subscales: Activity engagement (11 items) and Pain willingness (9 items), and a combined total score. Each item is rated on a scale of 0 -6. Higher scores indicate higher levels of acceptance.
The Brief Pain Inventory (BPI: pain interference) 3-months following surgery Pain interference: 7 items rated on 0= does not interfere to 10 = completely interferes
Generalized Anxiety Disorder 7-item scale 3-months following surgery Anxiety: score ranges from 0 (low anxiety) to 21 (high anxiety)
Pain catastrophizing Scale 3-months following surgery Pain catastrophizing: scores range from 0 (low catastrophizing) to 52 (high catastrophizing)
Patient Health Questionnaire -8 item 3-months following surgery Depression: scores range from 0 (low depression) to 24 (high depression)
SF-12 Health Survey 3-months following surgery Quality of Life: There are two subscales on this 12-item measure: the physical component summary and the mental component summary. Scores range from 0-100 with higher scores indicating better health.
Trial Locations
- Locations (1)
University of Iowa Hospital and Clinics
🇺🇸Iowa City, Iowa, United States