MedTrace Logo

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

NCT03430765 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2019-02-11

No results posted yet for this study

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.

Conditions

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

Interventions

BEHAVIORAL

Acceptance and Commitment Therapy

Single 2-hour individual Acceptance and Commitment Therapy coping skills session.

Sponsors & Collaborators

  • Holden Comprehensive Cancer Center

    collaborator OTHER

  • Katherine Hadlandsmyth

    lead OTHER

Principal Investigators

  • Katherine Hadlandsmyth, Ph.D. · University of Iowa Hospital and Clinics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-21
Primary Completion
2017-11-19
Completion
2017-11-22

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03430765 on ClinicalTrials.gov