Treatment Preference and Patient Centered Prostate Cancer Care
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|ClinicalTrials.gov Identifier: NCT02032550|
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : August 4, 2020
Last Update Posted : August 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Preference Based Decision Aid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||743 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Treatment Preference and Patient Centered Prostate Cancer Care|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||January 26, 2018|
|Actual Study Completion Date :||January 26, 2018|
Experimental: Preference Based Decision Aid
The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.
Other: Preference Based Decision Aid
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.
No Intervention: Usual Care
Participants randomized into this group will have usual care from their doctors without any intervention
- 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.
- 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.
- Anxiety [ Time Frame: baseline, 3, 6, 12, and 24 months ]Anxiety will be measured using Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scale
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- Decision Conflict [ Time Frame: 12 and 24 months ]The Decision Conflict Scale (DCS) will be used to measure decision conflict.
- Physician Trust [ Time Frame: baseline ]The Patient Trust-Wake Forest Physician Trust Scale will be used to measure trust
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032550
|United States, Pennsylvania|
|Philadelphia Veteran's Affairs Medical Center|
|Philadelphia, Pennsylvania, United States, 19104|
|University of Pennsylvania Health System|
|Philadelphia, Pennsylvania, United States, 19104|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Principal Investigator:||Ravishankar Jayadevappa, PhD||University of Pennsylvania|