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OpenTrials
Completed

NCT Number: NCT03950180

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men 18 years and older
  • Newly diagnosed prostate cancer

Exclusion criteria

  • Non-English speaking
  • Prior history of prostate cancer

Treatment and study plan

Prostate Cancer Comorbidity Index (PCCI) score

Other

Life expectancy information

Primary outcomes

  1. Traditional Decisional Conflict Scale (DCS)

    Time frame: 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 outcomes

  1. The Modified 18-item Memorial Anxiety Scale for Prostate Cancer

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Benaroya Research Institute

Other

Collaborators

  • Axio Research Corporation
  • Virginia Mason Hospital/Medical Center

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 15, 2019
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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