Prostate CancerNCT02032550
Treatment Preference and Patient Centered Prostate Cancer Care
A study testing Preference Based Decision Aid in people with Prostate Cancer, run by University of Pennsylvania at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Preference Based Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 743 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2013to 26 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed with non-metastatic prostate cancer
- Has not yet started radiation or surgery
- Provide informed consent
Who cannot join
- Distant, metastatic prostate cancer at diagnosis
- Has already begun treatment for prostate cancer
- Unable to communicate in English
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Philadelphia Veteran's Affairs Medical Center
Philadelphia, Pennsylvania, 19104
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Preference Based Decision Aid
- Keywords
- Localized prostate cancer, Patient preference, Treatment choice, Decision making, Patient centered outcomes
- Medical subject headings
- Prostatic Neoplasms, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preference Based Decision AidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Preference Based Decision Aid | Experimental | The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment. Receives: Other: Preference Based Decision Aid |
| Usual Care | No intervention | Participants randomized into this group will have usual care from their doctors without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 3, 6, 12 and 24 months
Secondary outcomes (7)
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.
Measured: baseline to 24 month
Anxiety
Anxiety will be measured using Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scale
Measured: baseline, 3, 6, 12, and 24 months
Urinary Symptoms
The American Urological Association Symptom Index (AUA-SI) will be used to measured urinary symptoms
Measured: baseline, 3, 6, 12, and 24 months
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.
Measured: 6 months
Depression
The Center for Epidemiologic Studies Depression (CES-D) scale will be used to measure depression.
Measured: baseline, 3, 6, 12, and 24 months
Satisfaction With Decision
The Satisfaction with Decision (SWD) will be used to measure satisfaction with decision at 3, 6, 12 and 24 months.
Measured: baseline, 3, 6, 12, and 24 months
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.
Measured: Baseline to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJun 2013
- Primary completion26 Jan 2018
- Study completion26 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 743 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Corporal Michael J. Crescenz VA Medical Center, Fox Chase Cancer Center
- Responsible party
- Sponsor
- Investigators
- Ravishankar Jayadevappa, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032550
- Sponsor's protocol ID
- PCC201
- Status last verified
- Jul 2020
- First submitted
- 23 Dec 2013
- Last updated
- 4 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chhatre S, Jefferson A, Cook R, Meeker CR, Kim JH, Hartz KM, Wong YN, Caruso A, Newman DK, Morales KH, Jayadevappa R. Patient-centered recruitment and retention for a randomized controlled study. Trials. 2018 Mar 27;19(1):205. doi: 10.1186/s13063-018-2578-7.
PubMed 29587805
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Preference and Patient Centered Prostate Cancer Care
- ClinicalTrials.gov ID
- NCT02032550
- Acronym / sponsor ID
- PCC201
- Conditions
- Prostate Cancer
- Keywords
- Localized prostate cancer, Patient preference, Treatment choice, Decision making, Patient centered outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 743 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Corporal Michael J. Crescenz VA Medical Center, Fox Chase Cancer Center
- Study start
- Jun 2013
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 26 Jan 2018 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Posted 4 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preference Based Decision Aid | Experimental | Other: Preference Based Decision AidThe experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment. |
| Usual Care | No intervention | –Participants randomized into this group will have usual care from their doctors without any intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly diagnosed with non-metastatic prostate cancer
- Has not yet started radiation or surgery
- Provide informed consent
Key exclusion criteria (3 listed)
- Distant, metastatic prostate cancer at diagnosis
- Has already begun treatment for prostate cancer
- Unable to communicate in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preference Based Decision AidThe 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. | Other | Preference Based Decision Aid |
Primary outcome
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.
7 secondary outcomes
Generic Health Related Quality of Life (HRQoL)
Time frame: baseline to 24 month
Anxiety
Time frame: baseline, 3, 6, 12, and 24 months
Urinary Symptoms
Time frame: baseline, 3, 6, 12, and 24 months
Treatment Choice
Time frame: 6 months
Depression
Time frame: baseline, 3, 6, 12, and 24 months
Satisfaction With Decision
Time frame: baseline, 3, 6, 12, and 24 months
Prostate Specific Health Related Quality of Life (HRQoL)
Time frame: Baseline to 24 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29587805Chhatre S, Jefferson A, Cook R, Meeker CR, Kim JH, Hartz KM, Wong YN, Caruso A, Newman DK, Morales KH, Jayadevappa R. Patient-centered recruitment and retention for a randomized controlled study. Trials. 2018 Mar 27;19(1):205. doi: 10.1186/s13063-018-2578-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravishankar Jayadevappa, PhD principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preference Based Decision Aid in people with Prostate Cancer, run by University of Pennsylvania at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Satisfaction With Care (time frame: baseline, 3, 6, 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02032550, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.