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.

Study Overview

• Status: Terminated
• Conditions: Cancer; Stress
• Intervention / Treatment: Behavioral: Behavioral Intervention for Wellness and Engaged Living (Be-WEL)

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
No Intervention: Standard Care; Standard Care consists of the standard care patients typically receive from their medical team.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical Outcomes Study Short Form-36 (SF-36) Physical Health Component Scale (PCS)	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.	4-weeks post-operation (+/-1 week)
Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component Scale (MCS)	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.	4-weeks post-operation (+/-1 week)
Number of Complications	Occurrence of: perioperative mortality, cardiac complications, postoperative pneumonia, intubation for >48-hours postoperatively unplanned reintubation, venous thromboembolic events, renal dysfunction, or surgical-site infections	30 days post-operation
Length of post-operative hospital stay	Number of days inpatient hospital stay after operation	30 days post-operation
Hospital Readmission	Number of times readmitted to a hospital after operation	30 days post-operation

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: Chelsea G Ratcliff, PhD, Baylor College of Medicine/Sam Houston State University

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Actual): November 12, 2024
• Study Completion (Actual): November 12, 2024

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: H-40276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not currently a plan to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No