Prostate Cancer
Conditions
Keywords
Localized prostate cancer, Patient preference, Treatment choice, Decision making, Patient centered outcomes
Brief summary
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.
Detailed description
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.
Interventions
OTHERPreference 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.
Sponsors
Patient-Centered Outcomes Research Institute
Corporal Michael J. Crescenz VA Medical Center
Fox Chase Cancer Center
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Newly diagnosed with non-metastatic prostate cancer 2. Has not yet started radiation or surgery 3. Provide informed consent
Exclusion criteria
1. Distant, metastatic prostate cancer at diagnosis 2. Has already begun treatment for prostate cancer 3. Unable to communicate in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Satisfaction With Care | 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
| Measure | Time frame | Description |
|---|---|---|
| Urinary Symptoms | baseline, 3, 6, 12, and 24 months | The American Urological Association Symptom Index (AUA-SI) will be used to measured urinary symptoms |
| Depression | 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 | 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) | 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. |
| Generic Health Related Quality of Life (HRQoL) | 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 | baseline, 3, 6, 12, and 24 months | Anxiety will be measured using Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scale |
| Treatment Choice | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Physician Trust | baseline | The Patient Trust-Wake Forest Physician Trust Scale will be used to measure trust |
| Preference for Participation in Treatment Decision | 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 | 12 and 24 months | The Decision Conflict Scale (DCS) will be used to measure decision conflict. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Preference Based Decision Aid The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.
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. | 371 |
| Usual Care Participants randomized into this group will have usual care from their doctors without any intervention | 372 |
| Total | 743 |
Baseline characteristics
| Characteristic | Preference Based Decision Aid | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 63.9 years STANDARD_DEVIATION 8 | 63.7 years STANDARD_DEVIATION 7.8 | 63.5 years STANDARD_DEVIATION 7.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 11 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 355 Participants | 706 Participants | 351 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants | 26 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 51 Participants | 102 Participants | 51 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 26 Participants | 15 Participants |
| Race (NIH/OMB) White | 306 Participants | 601 Participants | 295 Participants |
| Region of Enrollment United States | 371 participants | 743 participants | 372 participants |
| Satisfaction with care | 3.96 units on a scale STANDARD_DEVIATION 0.74 | 3.88 units on a scale STANDARD_DEVIATION 0.77 | 3.80 units on a scale STANDARD_DEVIATION 0.81 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 371 Participants | 743 Participants | 372 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 371 | 4 / 372 |
| other Total, other adverse events | 0 / 371 | 0 / 372 |
| serious Total, serious adverse events | 0 / 371 | 0 / 372 |
Outcome results
Primary
Change in Satisfaction With Care
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.
Time frame: baseline, 3, 6, 12 and 24 months
Population: All participants from both groups who were analyzed at end of 24 month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Preference Based Decision Aid | Change in Satisfaction With Care | Change at 3 month | 0.26 units on a scale | Standard Error 0.05 |
| Preference Based Decision Aid | Change in Satisfaction With Care | Change at 6 month | 0.28 units on a scale | Standard Error 0.05 |
| Preference Based Decision Aid | Change in Satisfaction With Care | Change at 12 month | 0.31 units on a scale | Standard Error 0.05 |
| Preference Based Decision Aid | Change in Satisfaction With Care | Change at 24 month | 0.44 units on a scale | Standard Error 0.06 |
| Usual Care | Change in Satisfaction With Care | Change at 24 month | 0.07 units on a scale | Standard Error 0.06 |
| Usual Care | Change in Satisfaction With Care | Change at 3 month | 0.07 units on a scale | Standard Error 0.05 |
| Usual Care | Change in Satisfaction With Care | Change at 12 month | 0.15 units on a scale | Standard Error 0.05 |
| Usual Care | Change in Satisfaction With Care | Change at 6 month | 0.06 units on a scale | Standard Error 0.05 |
Secondary
Anxiety
Anxiety will be measured using Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scale
Time frame: baseline, 3, 6, 12, and 24 months
Secondary
Depression
The Center for Epidemiologic Studies Depression (CES-D) scale will be used to measure depression.
Time frame: baseline, 3, 6, 12, and 24 months
Secondary
Generic Health Related Quality of Life (HRQoL)
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.
Time frame: baseline to 24 month
Population: All participants from both groups were analyzed at 24 month. Change in scores on domain of Physical Function is reported below.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preference Based Decision Aid | Generic Health Related Quality of Life (HRQoL) | -0.13 score on a scale | Standard Deviation 1.4 |
| Usual Care | Generic Health Related Quality of Life (HRQoL) | -2.9 score on a scale | Standard Deviation 1.3 |
Secondary
Prostate Specific Health Related Quality of Life (HRQoL)
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.
Time frame: Baseline to 24 month
Population: All participants from both groups were analyzed at 24 month. Proportion returning to baseline scores is reported for domain of urinary function below.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Preference Based Decision Aid | Prostate Specific Health Related Quality of Life (HRQoL) | 59.4 Proportion of participants |
| Usual Care | Prostate Specific Health Related Quality of Life (HRQoL) | 50 Proportion of participants |
Secondary
Satisfaction With Decision
The Satisfaction with Decision (SWD) will be used to measure satisfaction with decision at 3, 6, 12 and 24 months.
Time frame: baseline, 3, 6, 12, and 24 months
Secondary
Treatment Choice
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.
Time frame: 6 months
Secondary
Urinary Symptoms
The American Urological Association Symptom Index (AUA-SI) will be used to measured urinary symptoms
Time frame: baseline, 3, 6, 12, and 24 months
Other Pre-specified
Decision Conflict
The Decision Conflict Scale (DCS) will be used to measure decision conflict.
Time frame: 12 and 24 months
Other Pre-specified
Physician Trust
The Patient Trust-Wake Forest Physician Trust Scale will be used to measure trust
Time frame: baseline
Other Pre-specified
Preference for Participation in Treatment Decision
The Control Preferences Scale (CPS) assesses the role that patients want to play and perceive playing in treatment decisions.
Time frame: baseline, 3, 6, 12, and 24 months