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A Distress Screening and Intervention in Cancer Surgery

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ClinicalTrials.gov Identifier: NCT03979794
Recruitment Status : Not yet recruiting
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Chelsea Ratcliff, Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
Cancer Stress Behavioral: Behavioral Intervention for Wellness and Engaged Living (Be-WEL) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial (intervention vs. standard care)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Distress Screening and Intervention in Cancer Surgery
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Be-WEL Intervention
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)
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.

No Intervention: Standard Care
Standard Care consists of the standard care patients typically receive from their medical team.



Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Medical Outcomes Study Short Form-36 (SF-36) Physical Health Component Scale (PCS) [ Time Frame: 4-weeks post-operation (+/-1 week) ]
    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.

  2. Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component Scale (MCS) [ Time Frame: 4-weeks post-operation (+/-1 week) ]
    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.

  3. Number of Complications [ Time Frame: 30 days post-operation ]
    Occurrence of: perioperative mortality, cardiac complications, postoperative pneumonia, intubation for >48-hours postoperatively unplanned reintubation, venous thromboembolic events, renal dysfunction, or surgical-site infections

  4. Length of post-operative hospital stay [ Time Frame: 30 days post-operation ]
    Number of days inpatient hospital stay after operation

  5. Hospital Readmission [ Time Frame: 30 days post-operation ]
    Number of times readmitted to a hospital after operation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979794


Contacts
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Contact: Chelsea G Ratcliff, PhD 936-294-4662 chelsea.ratcliff@shsu.edu

Locations
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United States, Texas
Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
Contact: Chelsea G Ratcliff, PhD    281-744-7892    chelsea.ratcliff@bcm.com   
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Chelsea G Ratcliff, PhD Baylor College of Medicine/Sam Houston State University

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Responsible Party: Chelsea Ratcliff, Adjunct Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03979794     History of Changes
Other Study ID Numbers: H-40276
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not currently a plan to make individual participant data available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No