A Distress Screening and Intervention in Cancer Surgery

Study Overview
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Brief Summary
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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.

Official Title
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A Distress Screening and Intervention in Cancer Surgery

Conditions
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Cancer, Stress

Intervention / Treatment
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* Behavioral: Behavioral Intervention for Wellness and Engaged Living (Be-WEL)


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial (intervention vs. standard care)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Be-WEL Intervention<br>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)<br>* 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.<br>|
| No Intervention: Standard Care<br>Standard Care consists of the standard care patients typically receive from their medical team. | |

What is the study measuring?
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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 |