A Distress Screening and Intervention in Cancer Surgery

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2024

Interventions

  • Behavioral: Behavioral Intervention for Wellness and Engaged Living (Be-WEL)
    • Behavioral Intervention for Wellness and Engaged Living (Be-WEL) is a 4-session (2 preoperative, 2 postoperative) telephone intervention focused on improving emotional and physical health through relaxation, behavioral activation, increased physical activity, and adherence to medication and wound care.

Arms, Groups and Cohorts

  • Experimental: Be-WEL Intervention
    • Behavioral Intervention for Wellness and Engaged Living (Be-WEL) is a 4-session (2 preoperative, 2 postoperative) telephone intervention focused on improving emotional and physical health through relaxation, behavioral activation, increased physical activity, and adherence to medication and wound care.
  • No Intervention: Standard Care
    • Standard Care consists of the standard care patients typically receive from their medical team.

Clinical Trial Outcome Measures

Primary Measures

  • Patient Health Questionnaire-8
    • Time Frame: 4-weeks post-operation (+/-1 week)
    • PHQ-8 assesses depression symptoms; A total score (range: 0-24) will be used with higher scores representing more depressive symptoms.
  • Generalized Anxiety Disorder-7
    • Time Frame: 4-weeks post-operation (+/-1 week)
    • The GAD-7 measures anxiety symptoms; A total score (range: 0-21) will be used with higher scores representing more anxiety symptoms.

Secondary Measures

  • Medical Outcomes Study Short Form-36 (SF-36) Physical Health Component Scale (PCS)
    • Time Frame: 4-weeks post-operation (+/-1 week)
    • The SF-36 PCS assesses physical health-related quality of life (QOL) on a 0-100 scale (with a mean of 50 and standard deviation of 10 for general population). Higher scores represent higher physical health-related QOL.
  • Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component Scale (MCS)
    • Time Frame: 4-weeks post-operation (+/-1 week)
    • The SF-36 MCS assesses mental health-related quality of life (QOL) on a 0-100 scale (with a mean of 50 and standard deviation of 10 for general population). Higher scores represent higher mental health-related QOL.
  • Number of Complications
    • Time Frame: 30 days post-operation
    • Occurrence of: perioperative mortality, cardiac complications, postoperative pneumonia, intubation for >48-hours postoperatively unplanned reintubation, venous thromboembolic events, renal dysfunction, or surgical-site infections
  • Length of post-operative hospital stay
    • Time Frame: 30 days post-operation
    • Number of days inpatient hospital stay after operation
  • Hospital Readmission
    • Time Frame: 30 days post-operation
    • Number of times readmitted to a hospital after operation

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Baylor College of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chelsea Ratcliff, Adjunct Assistant Professor – Baylor College of Medicine
  • Overall Official(s)
    • Chelsea G Ratcliff, PhD, Principal Investigator, Baylor College of Medicine/Sam Houston State University
  • Overall Contact(s)
    • Chelsea G Ratcliff, PhD, 936-294-4662, chelsea.ratcliff@shsu.edu

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