Status:
COMPLETED
Preventing Persistent Pain and Reducing Depressive and Anxious Symptoms Following Mastectomy and Lumpectomy
Lead Sponsor:
Katherine Hadlandsmyth
Collaborating Sponsors:
Holden Comprehensive Cancer Center
Conditions:
Persistent Postsurgical Pain
Breast Cancer Female
Eligibility:
FEMALE
18-100 years
Phase:
NA
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) wi...
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 pa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 21 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2017
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03430765
Start Date
June 21 2015
End Date
November 22 2017
Last Update
February 11 2019
Active Locations (1)
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1
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242