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Completed

NCT Number: NCT02032550

Treatment Preference and Patient Centered Prostate Cancer Care

The purpose of this study is to develop a preference based decision aid to assess the treatment preferences of prostate cancer patients, and to analyze the interaction of treatment preferences, type of treatment received and their relationship with health related quality of life, satisfaction with care, decision regret, and psychological health of men with localized prostate cancer.

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Key information

Conditions

Prostate Cancer Behavior Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Health Behavior Male Urogenital Diseases Neoplasms Neoplasms by Site Patient Preference Patient Satisfaction Prostatic Diseases Prostatic Neoplasms Treatment Adherence and Compliance Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

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About this study

The objective is to test the comparative effectiveness of a conjoint analysis decision aid intervention compared to usual care. The investigators will identify preferred attributes of prostate cancer treatments that will help in designing a conjoint analysis decision aid to help patients weigh treatment attributes. The investigators will employ values markers to represent clusters of values for particular aspects of treatments that are valued most by individual patients. The investigators will test if the concordance between values markers and treatment received is predictive of objective outcomes and subjective outcomes. The study hypothesis is that conjoint task may help in treatment choice and prostate cancer patients whose treatment is more concordant with their values markers will have improved outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Newly diagnosed with non-metastatic prostate cancer
  • Has not yet started radiation or surgery
  • Provide informed consent

Exclusion criteria

  • Distant, metastatic prostate cancer at diagnosis
  • Has already begun treatment for prostate cancer
  • Unable to communicate in English

Treatment and study plan

Preference Based Decision Aid

Other

The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes.

Primary outcomes

  1. Change in Satisfaction With Care

    Time frame: baseline, 3, 6, 12 and 24 months

    The investigators will measure Satisfaction with Care (PSQ-18). : The PSQ-18 scale measures satisfaction with care at baseline 3, 6, 12, and 24 months. Higher score indicates better satisfaction with care. Positive change indicates improvement in satisfaction with care.

Secondary outcomes

  1. Generic Health Related Quality of Life (HRQoL)

    Time frame: baseline to 24 month

    Generic HRQoL data is obtained from Medical Outcome Study Short Form (SF-36) that assesses 8 health domains. Scores on each domain range from 0 to 100, higher scores indicating better generic HRQoL. Change in SF-36 domain scores between baseline to 24 month will be calculated as score at 24 month-score minus score at baseline. Positive change value indicates improvement in HRQoL from baseline to 24 month.

  2. Anxiety

    Time frame: baseline, 3, 6, 12, and 24 months

    Anxiety will be measured using Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scale

  3. Urinary Symptoms

    Time frame: baseline, 3, 6, 12, and 24 months

    The American Urological Association Symptom Index (AUA-SI) will be used to measured urinary symptoms

  4. Treatment Choice

    Time frame: 6 months

    The investigators will obtain data on primary and secondary treatments received, such as active surveillance, radical prostatectomy (RP), robotic-assisted laparoscopic prostatectomy (RALP), external beam radiation therapy (EBRT), brachytherapy (BT) or proton therapy (PT) via self report and verified from medical chart review.

  5. Depression

    Time frame: baseline, 3, 6, 12, and 24 months

    The Center for Epidemiologic Studies Depression (CES-D) scale will be used to measure depression.

  6. Satisfaction With Decision

    Time frame: baseline, 3, 6, 12, and 24 months

    The Satisfaction with Decision (SWD) will be used to measure satisfaction with decision at 3, 6, 12 and 24 months.

  7. Prostate Specific Health Related Quality of Life (HRQoL)

    Time frame: Baseline to 24 month

    Prostate specific HRQoL data is obtained from Expanded Prostate Cancer Index (EPIC), and measures four broad domains of urinary, bowel, sexual and hormonal symptoms. Scores on each sub-scale range from 0 to 100, with higher scores indicating better prostate cancer HRQoL. Proportion of participants returning to baseline scores will be calculated by comparing scores at baseline and at 24 month. Higher proportion indicates higher number of participants recovering baseline function by 24 month.

Other outcomes

  1. Preference for Participation in Treatment Decision

    Time frame: baseline, 3, 6, 12, and 24 months

    The Control Preferences Scale (CPS) assesses the role that patients want to play and perceive playing in treatment decisions.

  2. Decision Conflict

    Time frame: 12 and 24 months

    The Decision Conflict Scale (DCS) will be used to measure decision conflict.

  3. Physician Trust

    Time frame: baseline

    The Patient Trust-Wake Forest Physician Trust Scale will be used to measure trust

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Corporal Michael J. Crescenz VA Medical Center
  • Fox Chase Cancer Center
  • Patient-Centered Outcomes Research Institute

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jan 10, 2014
Registry last updated
Aug 4, 2020

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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