Breast Cancer Female, Ductal Carcinoma in Situ, Persistent Postsurgical Pain
Conditions
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.
Interventions
BEHAVIORALAcceptance and Commitment Therapy
Single 2-hour individual Acceptance and Commitment Therapy coping skills session.
Sponsors
Holden Comprehensive Cancer Center
Katherine Hadlandsmyth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale | 3-months following surgery | Surgical site pain severity (0 = no pain - 10 = pain as bad as you can imagine) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Patient Health Questionnaire -8 item | 3-months following surgery | Depression: scores range from 0 (low depression) to 24 (high depression) |
| 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) |
| Pain catastrophizing Scale | 3-months following surgery | Pain catastrophizing: scores range from 0 (low catastrophizing) to 52 (high catastrophizing) |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed