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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03430765
• Other study ID #: 201502709
• Status: Completed
• Phase: N/A
• Start date: June 21, 2015
• Est. completion date: November 22, 2017

Study information

• Verified date: February 2019
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 22, 2017
• Est. primary completion date: November 19, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma in Situ
• Persistent Postsurgical Pain

Intervention

Behavioral:
• Acceptance and Commitment Therapy
Single 2-hour individual Acceptance and Commitment Therapy coping skills session.

Locations

Country	Name	City	State
United States	University of Iowa Hospital and Clinics	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Katherine Hadlandsmyth	Holden Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

Dindo L, Recober A, Marchman JN, Turvey C, O'Hara MW. One-day behavioral treatment for patients with comorbid depression and migraine: a pilot study. Behav Res Ther. 2012 Sep;50(9):537-43. doi: 10.1016/j.brat.2012.05.007. Epub 2012 May 27. — View Citation

Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. — View Citation

Powers MB, Zum Vorde Sive Vording MB, Emmelkamp PM. Acceptance and commitment therapy: a meta-analytic review. Psychother Psychosom. 2009;78(2):73-80. doi: 10.1159/000190790. Epub 2009 Jan 14. — View Citation

Vowles, K.E., Wetherell, J.L., Sorrell, J.T. Targeting acceptance, mindfulness, and values-based action in chronic pain: Findings of two preliminary trials of an outpatient group-based intervention. Cognitive and Behavioral Practice 16: 49-58. 2009

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale	Surgical site pain severity (0 = no pain - 10 = pain as bad as you can imagine)	3-months following surgery
Secondary	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
Secondary	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
Secondary	Generalized Anxiety Disorder 7-item scale	Anxiety: score ranges from 0 (low anxiety) to 21 (high anxiety)	3-months following surgery
Secondary	Patient Health Questionnaire -8 item	Depression: scores range from 0 (low depression) to 24 (high depression)	3-months following surgery
Secondary	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
Secondary	Pain catastrophizing Scale	Pain catastrophizing: scores range from 0 (low catastrophizing) to 52 (high catastrophizing)	3-months following surgery
Secondary	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