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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Female; Ductal Carcinoma in Situ; Persistent Postsurgical Pain
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Katherine Hadlandsmyth
• Collaborators: Holden Comprehensive Cancer Center
• Investigators: Principal Investigator: Katherine Hadlandsmyth, Ph.D., University of Iowa Hospital and Clinics

Publications and helpful links

General Publications

• 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. doi: 10.1016/j.brat.2005.06.006.
• 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.
• 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.
• 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

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2015
• Primary Completion (Actual): November 19, 2017
• Study Completion (Actual): November 22, 2017

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Postoperative Complications; Pain; Neurologic Manifestations; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ; Pain, Postoperative; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
• Other Study ID Numbers: 201502709

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No