Trial Outcomes & Findings for Treatment Preference and Patient Centered Prostate Cancer Care (NCT NCT02032550)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

743 participants

Primary outcome timeframe

baseline, 3, 6, 12 and 24 months

Results posted on

2020-08-04

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Usual Care Participants randomized into this group will have usual care from their doctors without any intervention
Overall Study STARTED	371	372
Overall Study COMPLETED	343	350
Overall Study NOT COMPLETED	28	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment Preference and Patient Centered Prostate Cancer Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Preference Based Decision Aid n=371 Participants 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.	Usual Care n=372 Participants Participants randomized into this group will have usual care from their doctors without any intervention	Total n=743 Participants Total of all reporting groups
Age, Continuous	63.9 years STANDARD_DEVIATION 8.0 • n=93 Participants	63.5 years STANDARD_DEVIATION 7.6 • n=4 Participants	63.7 years STANDARD_DEVIATION 7.8 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	371 Participants n=93 Participants	372 Participants n=4 Participants	743 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	355 Participants n=93 Participants	351 Participants n=4 Participants	706 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=93 Participants	15 Participants n=4 Participants	26 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	6 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	51 Participants n=93 Participants	51 Participants n=4 Participants	102 Participants n=27 Participants
Race (NIH/OMB) White	306 Participants n=93 Participants	295 Participants n=4 Participants	601 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=93 Participants	15 Participants n=4 Participants	26 Participants n=27 Participants
Region of Enrollment United States	371 participants n=93 Participants	372 participants n=4 Participants	743 participants n=27 Participants
Satisfaction with care	3.96 units on a scale STANDARD_DEVIATION 0.74 • n=93 Participants	3.80 units on a scale STANDARD_DEVIATION 0.81 • n=4 Participants	3.88 units on a scale STANDARD_DEVIATION 0.77 • n=27 Participants

PRIMARY outcome

Timeframe: baseline, 3, 6, 12 and 24 months

Population: All participants from both groups who were analyzed at end of 24 month follow-up.

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.

Outcome measures

Outcome measures
Measure	Preference Based Decision Aid n=343 Participants 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.	Usual Care n=350 Participants Participants randomized into this group will have usual care from their doctors without any intervention
Change in Satisfaction With Care Change at 3 month	0.26 units on a scale Standard Error 0.05	0.07 units on a scale Standard Error 0.05
Change in Satisfaction With Care Change at 6 month	0.28 units on a scale Standard Error 0.05	0.06 units on a scale Standard Error 0.05
Change in Satisfaction With Care Change at 12 month	0.31 units on a scale Standard Error 0.05	0.15 units on a scale Standard Error 0.05
Change in Satisfaction With Care Change at 24 month	0.44 units on a scale Standard Error 0.06	0.07 units on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Preference Based Decision Aid n=343 Participants 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.	Usual Care n=350 Participants Participants randomized into this group will have usual care from their doctors without any intervention
Generic Health Related Quality of Life (HRQoL)	-0.13 score on a scale Standard Deviation 1.4	-2.9 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: baseline, 3, 6, 12, and 24 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 3, 6, 12, and 24 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 3, 6, 12, and 24 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Preference Based Decision Aid n=343 Participants 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.	Usual Care n=350 Participants Participants randomized into this group will have usual care from their doctors without any intervention
Prostate Specific Health Related Quality of Life (HRQoL)	59.4 Proportion of participants	50 Proportion of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 and 24 months

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline

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

Outcome measures

Outcome data not reported

Adverse Events

Preference Based Decision Aid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ravishankar Jayadevappa

University of Pennsylvania

Phone: 215-898-3798

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place