A Distress Screening and Intervention in Cancer Surgery
- Conditions
- CancerStress
- Interventions
- Behavioral: Behavioral Intervention for Wellness and Engaged Living (Be-WEL)
- Registration Number
- NCT03979794
- Lead Sponsor
- Baylor College of Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Be-WEL Intervention 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.
- Primary Outcome Measures
Name Time Method Patient Health Questionnaire-8 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 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 Outcome Measures
Name Time Method Hospital Readmission 30 days post-operation Number of times readmitted to a hospital after operation
Number of Complications 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
Medical Outcomes Study Short Form-36 (SF-36) Physical Health Component Scale (PCS) 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.
Length of post-operative hospital stay 30 days post-operation Number of days inpatient hospital stay after operation
Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component Scale (MCS) 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.
Trial Locations
- Locations (1)
Baylor College of Medicine
🇺🇸Houston, Texas, United States