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OpenTrials
Completed

NCT Number: NCT03430765

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Acceptance and Commitment Therapy

Behavioral

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Katherine Hadlandsmyth

Other

Collaborators

  • Holden Comprehensive Cancer Center

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 13, 2018
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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