NCT03430765

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Katherine Hadlandsmyth · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Persistent Postsurgical Pain
• Breast Cancer Female
• Ductal Carcinoma in Situ

Interventions

Type	Name	Description
BEHAVIORAL	Acceptance and Commitment Therapy	Single 2-hour individual Acceptance and Commitment Therapy coping skills session.

Timeline

• Start date: 2015-06-21
• Primary completion: 2017-11-19
• Completion: 2017-11-22
• First posted: 2018-02-13
• Last updated: 2019-02-11

Locations

1 site across 1 country: United States