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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03430765
Recruitment Status : Completed
First Posted : February 13, 2018
Last Update Posted : February 11, 2019
Holden Comprehensive Cancer Center
Information provided by (Responsible Party):
Katherine Hadlandsmyth, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Persistent Postsurgical Pain Breast Cancer Female Ductal Carcinoma in Situ Behavioral: Acceptance and Commitment Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Persistent Pain and Reducing Depressive and Anxious Symptoms Following Mastectomy and Lumpectomy
Actual Study Start Date : June 21, 2015
Actual Primary Completion Date : November 19, 2017
Actual Study Completion Date : November 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

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.

Primary Outcome Measures :
  1. Numeric Rating Scale [ Time Frame: 3-months following surgery ]
    Surgical site pain severity (0 = no pain - 10 = pain as bad as you can imagine)

Secondary Outcome Measures :
  1. The Brief Pain Inventory (BPI: pain severity) [ Time Frame: 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)

  2. The Brief Pain Inventory (BPI: pain interference) [ Time Frame: 3-months following surgery ]
    Pain interference: 7 items rated on 0= does not interfere to 10 = completely interferes

  3. Generalized Anxiety Disorder 7-item scale [ Time Frame: 3-months following surgery ]
    Anxiety: score ranges from 0 (low anxiety) to 21 (high anxiety)

  4. Patient Health Questionnaire -8 item [ Time Frame: 3-months following surgery ]
    Depression: scores range from 0 (low depression) to 24 (high depression)

  5. SF-12 Health Survey [ Time Frame: 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.

  6. Pain catastrophizing Scale [ Time Frame: 3-months following surgery ]
    Pain catastrophizing: scores range from 0 (low catastrophizing) to 52 (high catastrophizing)

  7. Chronic Pain Acceptance Questionnaire [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03430765

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United States, Iowa
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Katherine Hadlandsmyth
Holden Comprehensive Cancer Center
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Principal Investigator: Katherine Hadlandsmyth, Ph.D. University of Iowa Hospital and Clinics

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Responsible Party: Katherine Hadlandsmyth, Clinical Assistant Professor of Anesthesia - Chronic Pain Medicine, University of Iowa Identifier: NCT03430765     History of Changes
Other Study ID Numbers: 201502709
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ