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NCT03430765

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

Completed NA Last updated 11 February 2019
What this trial tests

NA trial testing Acceptance and Commitment Therapy in Persistent Postsurgical Pain in 62 participants. Completed in 22 November 2017.

Timeline
21 June 2015
Primary endpoint
19 November 2017
22 November 2017

Quick facts

Lead sponsorKatherine Hadlandsmyth
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment62
Start date21 June 2015
Primary completion19 November 2017
Estimated completion22 November 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Katherine Hadlandsmyth

Who can join

Adults 18 to 100, female only, with Persistent Postsurgical Pain or Breast Cancer Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A single-session acceptance and commitment therapy intervention among women undergoing surgery for breast cancer: A randomized pilot trial to reduce persistent postsurgical pain.
    Hadlandsmyth K, Dindo LN, Wajid R, Sugg SL, et al · · 2019 · cited 27× · PMID 31430830 · DOI 10.1002/pon.5209

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Other trials of Acceptance and Commitment Therapy

Trials testing the same drug.

Other recruiting trials for Persistent Postsurgical Pain

Currently open trials in the same condition.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03430765.

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