Preventing Persistent Pain and Reducing Depressive and Anxious Symptoms Following Mastectomy and Lumpectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preventing Persistent Pain and Reducing Depressive and Anxious Symptoms Following Mastectomy and Lumpectomy

Conditions
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Persistent Postsurgical Pain, Breast Cancer Female, Ductal Carcinoma in Situ

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1) ≥18 years of age, 2) scheduled for mastectomy or lumpectomy for breast cancer or DCIS, 3) identified to be at risk (per guidelines below). At risk criteria: Psychological distress (elevated anxiety, depression, or pain catastrophizing), under the age of 50, or with a pre-existing chronic pain condition. Scores of 10 or above on the Generalized Anxiety Disorders 7-item scale or the Personal Health Questionnaire Depression 8 item Scale will indicate elevated anxiety or depression. A score of 30 or above on the Pain Catastrophizing Scale will indicate elevated catastrophizing. Exclusion Criteria: 1) language or cognitive barriers preventing completion of questionnaires, 2) severe psychiatric disorder: bipolar or psychotic disorder, 3) significant surgical complications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acceptance and Commitment Therapy<br>Standard breast cancer treatment plus a single 2 hour individual Acceptance and Commitment Therapy coping skills session. | Behavioral: Acceptance and Commitment Therapy<br>* Single 2-hour individual Acceptance and Commitment Therapy coping skills session.<br>|
| No Intervention: Treatment as Usual<br>Standard breast cancer treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale | Surgical site pain severity (0 = no pain - 10 = pain as bad as you can imagine) | 3-months following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Brief Pain Inventory (BPI: pain severity) | Pain severity: four items: Average pain, worst in 24 hours, least in 24 hours, and right now (on a 0-10 scale) | 3-months following surgery | 
| The Brief Pain Inventory (BPI: pain interference) | Pain interference: 7 items rated on 0= does not interfere to 10 = completely interferes | 3-months following surgery | 
| Generalized Anxiety Disorder 7-item scale | Anxiety: score ranges from 0 (low anxiety) to 21 (high anxiety) | 3-months following surgery | 
| Patient Health Questionnaire -8 item | Depression: scores range from 0 (low depression) to 24 (high depression) | 3-months following surgery | 
| SF-12 Health Survey | 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. | 3-months following surgery | 
| Pain catastrophizing Scale | Pain catastrophizing: scores range from 0 (low catastrophizing) to 52 (high catastrophizing) | 3-months following surgery | 
| Chronic Pain Acceptance Questionnaire | 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. | 3-months following surgery |