A Distress Screening and Intervention in Cancer Surgery

Baylor College of Medicine

Status: Terminated

Conditions: Cancer; Stress

Treatments: Behavioral: Behavioral Intervention for Wellness and Engaged Living (Be-WEL)

Study type: Interventional

Funder types: Other

Identifiers

NCT03979794

H-40276

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Be-WEL Intervention

Experimental group

Description:

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.

Treatment:

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

Standard Care

No Intervention group

Description:

Standard Care consists of the standard care patients typically receive from their medical team.