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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Prostate Cancer Comorbidity Index (PCCI) score

• Registration Number: NCT03950180
• Lead Sponsor: Benaroya Research Institute

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.

Study Timeline

• Study Start: 2013-07-12
• Primary Completion: 2015-02-27
• Study Completion: 2015-02-27
• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-15
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-10
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 277

Inclusion Criteria

• Men 18 years and older
• Newly diagnosed prostate cancer

Exclusion Criteria

• Non-English speaking
• Prior history of prostate cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCCI group	Prostate Cancer Comorbidity Index (PCCI) score	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.

Primary Outcome Measures

Name	Time	Method
Traditional Decisional Conflict Scale (DCS)	within 120 days of receiving counseling	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

Name	Time	Method
The Modified 18-item Memorial Anxiety Scale for Prostate Cancer	within 120 days of receiving counseling	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.