NCT03979794

A Distress Screening and Intervention in Cancer Surgery

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Stress

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-12-17
• Primary completion: 2024-11-12
• Completion: 2024-11-12
• First posted: 2019-06-07
• Last updated: 2024-11-14

Locations

1 site across 1 country: United States