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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03950180
• Other study ID #: IRB13054
• Status: Completed
• Phase: N/A
• Start date: July 12, 2013
• Est. completion date: February 27, 2015

Study information

• Verified date: June 2019
• Source: Benaroya Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: February 27, 2015
• Est. primary completion date: February 27, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men 18 years and older

• Newly diagnosed prostate cancer

Exclusion Criteria:

• Non-English speaking

• Prior history of prostate cancer

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Other:
• Prostate Cancer Comorbidity Index (PCCI) score
Life expectancy information

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Benaroya Research Institute	Axio Research Corporation, Virginia Mason Hospital/Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 120 days of receiving counseling
Secondary	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.	within 120 days of receiving counseling