A Distress Screening and Intervention in Cancer Surgery
The goal of this project is to examine initial effectiveness of a brief (2 preoperative, 2 postoperative session) cognitive behaviorally-based telephone intervention compared to standard care on postoperative outcomes for patients who are scheduled to undergo a cancer-related surgery in 12 or more days and screen positive for distress (4 or higher on 0-10 Distress Thermometer). The intervention focuses on improving emotional and physical health through relaxation, behavioral activation, increased physical activity, and adherence to medication and wound care. Participants will be randomly assigned to receive the intervention or to receive standard care. Outcomes assessed 4 and 6 weeks post-operatively will include: Depression (Patient Health Questionnaire-8), anxiety (Generalized Anxiety Disorder-7), health-related QOL (SF-36 MCS and PCS), number and type of complications, length of stay, and 30-day readmission.
Conditions:
🦠 Cancer 🦠 Stress
🗓️ Study Start (Actual) 17 December 2020
🗓️ Primary Completion (Estimated) 30 September 2024
✅ Study Completion (Estimated) 30 November 2024
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Houston, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * ADULT (18 years of age or older)
    • * SCHEDULED FOR SURGERY FOR CANCER (excluding non-melanoma skin cancer) 12 OR MORE DAYS IN ADVANCE OF CONSENT
    • * SIGNIFICANTLY DISTRESSED (\>4 on the 0-10 Distress Thermometer)
    • * ABLE TO SPEAK ENGLISH

    Exclusion Criteria:

    • * COGNITIVE IMPAIRMENT : \<4 on baseline Mini Cog measure
    • * SERIOUS MENTAL ILLNESS: a diagnosis of a bipolar or psychotic disorder (noted in medical record)
    • * NON-ENGLISH SPEAKING: This study only involves participants who can speak English.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 May 2019
  • First Submitted that Met QC Criteria 6 June 2019
  • First Posted 7 June 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 March 2024
  • Last Update Posted 22 March 2024
  • Last Verified March 2024