search
Back to results

Assessing The Impact Of Incorporating Charlson Comorbidity Scores On Patient Anxiety And Satisfaction

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prostate Cancer Comorbidity Index (PCCI) score
Sponsored by
Benaroya Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Men 18 years and older
  • Newly diagnosed prostate cancer

Exclusion Criteria:

  • Non-English speaking
  • Prior history of prostate cancer

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    PCCI group

    Standard care

    Arm Description

    In addition to standard of care counseling the additional provision of the patient's specific Prostate Cancer Comorbidity Index score and life expectancy estimation was provided.

    Standard of care was defined as prostate cancer counseling reflecting the best practices of a multidisciplinary team of urologists, radiation oncologists and medical oncologists.

    Outcomes

    Primary Outcome Measures

    Traditional Decisional Conflict Scale (DCS)
    This is to assess the ability to implement decisions. Each of the 16 questions range from strongly agree (a score of 1), to strongly disagree (a score of 5). The total score could be as low as 16 or as high as 80. A lower total score represents a better outcome, with a score of <25 associated with the ability to implement decisions and a score of >37.5 associated with decision delay and feeling unsure.

    Secondary Outcome Measures

    The Modified 18-item Memorial Anxiety Scale for Prostate Cancer
    This is to assess anxiety about prostate cancer. Each of the 18 questions range from not at all (a score of 1) to often (a score of 4). The total score could range from 18 to 72. A lower total score indicates less anxiety about prostate cancer and a lower score represents the better the outcome.

    Full Information

    First Posted
    May 9, 2019
    Last Updated
    June 10, 2019
    Sponsor
    Benaroya Research Institute
    Collaborators
    Virginia Mason Hospital/Medical Center, Axio Research Corporation
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03950180
    Brief Title
    Assessing The Impact Of Incorporating Charlson Comorbidity Scores On Patient Anxiety And Satisfaction
    Official Title
    Assessing The Impact Of Incorporating Charlson Comorbidity Scores On Patient Anxiety And Satisfaction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    July 12, 2013 (Actual)
    Primary Completion Date
    February 27, 2015 (Actual)
    Study Completion Date
    February 27, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Benaroya Research Institute
    Collaborators
    Virginia Mason Hospital/Medical Center, Axio Research Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to determine whether providing patients with life expectancy (LE) information in the form of their Prostate Cancer Comorbidity Index (PCCI) scores impacted their decisional conflict or anxiety about prostate cancer or death.
    Detailed Description
    Patients with newly diagnosed prostate cancer were consented and randomized to receive standard of care counseling (SOC) versus the same counseling plus provision of their specific LE (PCCI). Patients were blinded to the specific content of their counseling session. After counseling, patients completed the Decisional Conflict Scale (DCS), Death Anxiety Scale (DAS), Memorial Anxiety Scale for Prostate Cancer (MAX-PC), and Patient Satisfaction Questionnaire (PSQ-18). Treatment preferences were assessed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    277 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PCCI group
    Arm Type
    Active Comparator
    Arm Description
    In addition to standard of care counseling the additional provision of the patient's specific Prostate Cancer Comorbidity Index score and life expectancy estimation was provided.
    Arm Title
    Standard care
    Arm Type
    No Intervention
    Arm Description
    Standard of care was defined as prostate cancer counseling reflecting the best practices of a multidisciplinary team of urologists, radiation oncologists and medical oncologists.
    Intervention Type
    Other
    Intervention Name(s)
    Prostate Cancer Comorbidity Index (PCCI) score
    Intervention Description
    Life expectancy information
    Primary Outcome Measure Information:
    Title
    Traditional Decisional Conflict Scale (DCS)
    Description
    This is to assess the ability to implement decisions. Each of the 16 questions range from strongly agree (a score of 1), to strongly disagree (a score of 5). The total score could be as low as 16 or as high as 80. A lower total score represents a better outcome, with a score of <25 associated with the ability to implement decisions and a score of >37.5 associated with decision delay and feeling unsure.
    Time Frame
    within 120 days of receiving counseling
    Secondary Outcome Measure Information:
    Title
    The Modified 18-item Memorial Anxiety Scale for Prostate Cancer
    Description
    This is to assess anxiety about prostate cancer. Each of the 18 questions range from not at all (a score of 1) to often (a score of 4). The total score could range from 18 to 72. A lower total score indicates less anxiety about prostate cancer and a lower score represents the better the outcome.
    Time Frame
    within 120 days of receiving counseling

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men 18 years and older Newly diagnosed prostate cancer Exclusion Criteria: Non-English speaking Prior history of prostate cancer
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John M Corman, MD
    Organizational Affiliation
    Benaroya Research Institute at Virginia Mason
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Assessing The Impact Of Incorporating Charlson Comorbidity Scores On Patient Anxiety And Satisfaction

    We'll reach out to this number within 24 hrs