A Distress Screening and Intervention in Cancer Surgery

Cancer Clinical Trial

Official title:

A Distress Screening and Intervention in Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03979794
• Other study ID #: H-40276
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2020
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2024
• Source: Baylor College of Medicine
• Contact: Chelsea G Ratcliff, PhD
• Phone: 936-294-4662
• Email: chelsea.ratcliff[@]shsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Stress

Intervention

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.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	Length of post-operative hospital stay	Number of days inpatient hospital stay after operation	30 days post-operation
Secondary	Hospital Readmission	Number of times readmitted to a hospital after operation	30 days post-operation