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

Completed · Not applicable

Conditions studied: Persistent Postsurgical Pain, Breast Cancer Female, Ductal Carcinoma in Situ

In brief

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.

Key facts

Study ID

NCT03430765

Run by

Katherine Hadlandsmyth

People needed

62

Starts

2015-06-21

Expected to finish

2017-11-22

Last updated by the study team

2019-02-11

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

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

Where it is running

• University of Iowa Hospital and Clinics — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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