A Distress Screening and Intervention in Cancer Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Baylor College of Medicine
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Patient Health Questionnaire-8
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Chelsea Ratcliff
Adjunct Assistant Professor
Baylor College of Medicine
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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 Outcomes
- Hospital Readmission(30 days post-operation)
- Number of Complications(30 days post-operation)
- Medical Outcomes Study Short Form-36 (SF-36) Physical Health Component Scale (PCS)(4-weeks post-operation (+/-1 week))
- Length of post-operative hospital stay(30 days post-operation)
- Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component Scale (MCS)(4-weeks post-operation (+/-1 week))