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.|
|ClinicalTrials.gov Identifier: NCT03430765|
Recruitment Status : Completed
First Posted : February 13, 2018
Last Update Posted : February 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Persistent Postsurgical Pain Breast Cancer Female Ductal Carcinoma in Situ||Behavioral: Acceptance and Commitment Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Controlled Trial|
|Masking:||None (Open Label)|
|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|
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.
- Numeric Rating Scale [ Time Frame: 3-months following surgery ]Surgical site pain severity (0 = no pain - 10 = pain as bad as you can imagine)
- 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)
- 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
- Generalized Anxiety Disorder 7-item scale [ Time Frame: 3-months following surgery ]Anxiety: score ranges from 0 (low anxiety) to 21 (high anxiety)
- Patient Health Questionnaire -8 item [ Time Frame: 3-months following surgery ]Depression: scores range from 0 (low depression) to 24 (high depression)
- 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.
- Pain catastrophizing Scale [ Time Frame: 3-months following surgery ]Pain catastrophizing: scores range from 0 (low catastrophizing) to 52 (high catastrophizing)
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03430765
|United States, Iowa|
|University of Iowa Hospital and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Katherine Hadlandsmyth, Ph.D.||University of Iowa Hospital and Clinics|