A Distress Screening and Intervention in Cancer Surgery

NCT03979794 | Terminated

• 1 other identifier: H-40276
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Stress

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Medical Outcomes Study Short Form-36 (SF-36) Physical Health Component Scale (PCS)

  4-weeks post-operation (+/-1 week)

• Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component Scale (MCS)

  4-weeks post-operation (+/-1 week)

• Number of Complications

  30 days post-operation

• Length of post-operative hospital stay

  30 days post-operation

• Hospital Readmission

  30 days post-operation

Study Arms (2)

Be-WEL Intervention

EXPERIMENTAL

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)

Standard Care

NO INTERVENTION

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

Interventions

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

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.

Be-WEL Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Behavior Therapy; Health

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Population Characteristics

Study Officials

• Chelsea G Ratcliff, PhD

  Baylor College of Medicine/Sam Houston State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Assistant Professor

Model Details: Randomized Controlled Trial (intervention vs. standard care)

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 7, 2019
• Study Start: December 17, 2020
• Primary Completion: November 12, 2024
• Study Completion: November 12, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)