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

NCT03430765 | Completed

• 1 other identifier: 201502709
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale

  Surgical site pain severity (0 = no pain - 10 = pain as bad as you can imagine)

  3-months following surgery

Secondary Outcomes (7)

• The Brief Pain Inventory (BPI: pain severity)

  3-months following surgery

• The Brief Pain Inventory (BPI: pain interference)

  3-months following surgery

• Generalized Anxiety Disorder 7-item scale

  3-months following surgery

• Patient Health Questionnaire -8 item

  3-months following surgery

• SF-12 Health Survey

  3-months following surgery

Study Arms (2)

Acceptance and Commitment Therapy

EXPERIMENTAL

Standard breast cancer treatment plus a single 2 hour individual Acceptance and Commitment Therapy coping skills session.

Behavioral: Acceptance and Commitment Therapy

Treatment as Usual

NO INTERVENTION

Standard breast cancer treatment.

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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

Acceptance and Commitment Therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \) language or cognitive barriers preventing completion of questionnaires, 2) severe psychiatric disorder: bipolar or psychotic disorder, 3) significant surgical complications.

Sponsors & Collaborators

• Katherine Hadlandsmyth: lead
• Holden Comprehensive Cancer Center: collaborator

Study Sites (1)

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

Related 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.

  PMID: 22728646 BACKGROUND

• 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.

  PMID: 16300724 BACKGROUND

• 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.

  PMID: 19142046 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Carcinoma, Intraductal, Noninfiltrating

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Katherine Hadlandsmyth, Ph.D.

  University of Iowa Hospital and Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor of Anesthesia - Chronic Pain Medicine

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 13, 2018
• Study Start: June 21, 2015
• Primary Completion: November 19, 2017
• Study Completion: November 22, 2017
• Last Updated: February 11, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)