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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Sponsored by
Katherine Hadlandsmyth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Persistent Postsurgical Pain

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Iowa Hospital and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acceptance and Commitment Therapy

Treatment as Usual

Arm Description

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

Standard breast cancer treatment.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
The Brief Pain Inventory (BPI: pain interference)
Pain interference: 7 items rated on 0= does not interfere to 10 = completely interferes
Generalized Anxiety Disorder 7-item scale
Anxiety: score ranges from 0 (low anxiety) to 21 (high anxiety)
Patient Health Questionnaire -8 item
Depression: scores range from 0 (low depression) to 24 (high depression)
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.
Pain catastrophizing Scale
Pain catastrophizing: scores range from 0 (low catastrophizing) to 52 (high catastrophizing)
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.

Full Information

First Posted
February 6, 2018
Last Updated
February 7, 2019
Sponsor
Katherine Hadlandsmyth
Collaborators
Holden Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03430765
Brief Title
Preventing Persistent Pain and Reducing Depressive and Anxious Symptoms Following Mastectomy and Lumpectomy
Official Title
Preventing Persistent Pain and Reducing Depressive and Anxious Symptoms Following Mastectomy and Lumpectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 21, 2015 (Actual)
Primary Completion Date
November 19, 2017 (Actual)
Study Completion Date
November 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Katherine Hadlandsmyth
Collaborators
Holden Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Postsurgical Pain, Breast Cancer Female, Ductal Carcinoma in Situ

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acceptance and Commitment Therapy
Arm Type
Experimental
Arm Description
Standard breast cancer treatment plus a single 2 hour individual Acceptance and Commitment Therapy coping skills session.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Standard breast cancer treatment.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Intervention Description
Single 2-hour individual Acceptance and Commitment Therapy coping skills session.
Primary Outcome Measure Information:
Title
Numeric Rating Scale
Description
Surgical site pain severity (0 = no pain - 10 = pain as bad as you can imagine)
Time Frame
3-months following surgery
Secondary Outcome Measure Information:
Title
The Brief Pain Inventory (BPI: pain severity)
Description
Pain severity: four items: Average pain, worst in 24 hours, least in 24 hours, and right now (on a 0-10 scale)
Time Frame
3-months following surgery
Title
The Brief Pain Inventory (BPI: pain interference)
Description
Pain interference: 7 items rated on 0= does not interfere to 10 = completely interferes
Time Frame
3-months following surgery
Title
Generalized Anxiety Disorder 7-item scale
Description
Anxiety: score ranges from 0 (low anxiety) to 21 (high anxiety)
Time Frame
3-months following surgery
Title
Patient Health Questionnaire -8 item
Description
Depression: scores range from 0 (low depression) to 24 (high depression)
Time Frame
3-months following surgery
Title
SF-12 Health Survey
Description
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.
Time Frame
3-months following surgery
Title
Pain catastrophizing Scale
Description
Pain catastrophizing: scores range from 0 (low catastrophizing) to 52 (high catastrophizing)
Time Frame
3-months following surgery
Title
Chronic Pain Acceptance Questionnaire
Description
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.
Time Frame
3-months following surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Hadlandsmyth, Ph.D.
Organizational Affiliation
University of Iowa Hospital and Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22728646
Citation
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.
Results Reference
background
PubMed Identifier
16300724
Citation
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.
Results Reference
background
PubMed Identifier
19142046
Citation
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.
Results Reference
background
Citation
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
Results Reference
background

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

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