免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / A Distress Screening and Intervention in Cancer Surgery

A Distress Screening and Intervention in Cancer Surgery

Study Description
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) Not Applicable

Study Design
Layout table for study information
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
Actual Study Start Date : December 17, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : October 31, 2022
Arms and Interventions
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.
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Chelsea G Ratcliff, PhD 936-294-4662 chelsea.ratcliff@shsu.edu

Locations
Layout table for location information
United States, Texas
Baylor College of Medicine 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
Layout table for investigator information
Principal Investigator: Chelsea G Ratcliff, PhD Baylor College of Medicine/Sam Houston State University
Tracking Information
First Submitted Date  ICMJE May 28, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date January 20, 2021
Actual Study Start Date  ICMJE December 17, 2020
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • 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.
  • 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.
  • 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
  • Length of post-operative hospital stay [ Time Frame: 30 days post-operation ]
    Number of days inpatient hospital stay after operation
  • Hospital Readmission [ Time Frame: 30 days post-operation ]
    Number of times readmitted to a hospital after operation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Distress Screening and Intervention in Cancer Surgery
Official Title  ICMJE A Distress Screening and Intervention in Cancer Surgery
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized Controlled Trial (intervention vs. standard care)
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Stress
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Behavioral Intervention for Wellness and Engaged Living (Be-WEL)
  • No Intervention: Standard Care
    Standard Care consists of the standard care patients typically receive from their medical team.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2022
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chelsea G Ratcliff, PhD 936-294-4662 chelsea.ratcliff@shsu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03979794
Other Study ID Numbers  ICMJE H-40276
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is not currently a plan to make individual participant data available to other researchers.
Responsible Party Chelsea Ratcliff, Baylor College of Medicine
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chelsea G Ratcliff, PhD Baylor College of Medicine/Sam Houston State University
PRS Account Baylor College of Medicine
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯