Prostate CancerNCT03157947
Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer
A study testing Decision Aid Tool, baseline survey and follow-up surveys in people with Prostate Cancer, run by Case Comprehensive Cancer Center.
Trial summary
A pilot study testing the effect of an in-visit English and Spanish language decision aid for Hispanic-Latino men using best practices of cultural tailoring to be used in urology practice. Subjects will be followed for approximately 1 year during standard care in-clinic office visits. 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?
- Decision Aid Tool, baseline survey and follow-up surveys
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2017to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subjects utilize English or Spanish as their primary spoken or written language and identify with a Latino ethnicity and/or culture
- Men with a new histologic diagnosis of localized prostate cancer
- PSA level of 0.1 - 50 ng/dl
- Gleason score of 6 - 10
- Cancer stage: T1 - 4N x M0
Who cannot join
- Metastatic disease, including lymph nodes or distant metastasis
- PSA > 50 ng/dl
- Individuals with a medical condition that necessitates a specific prostate cancer treatment plan
- Individuals that are unwilling or unable to attend study visits or are planning to move out of a study site coverage area during the subject's anticipated participation in the study
About this study
Official title: Development and Testing of a Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer
A pilot study testing the effect of an in-visit English and Spanish language decision aid for Hispanic-Latino men using best practices of cultural tailoring to be used in urology practice. Subjects will be followed for approximately 1 year during standard care in-clinic office visits. Study results and subject surveys will be analyzed to determine clinical utility of the tool.
Read the detailed description
The objective of this research is to determine the effect of a culturally tailored decision aid tool on the cancer treatment decisions of Hispanic-Latino patients.
The specific aims are:
- To develop and pilot test in an uncontrolled fashion an in-visit English and Spanish language decision aid for Hispanic-Latino men using best practices of cultural tailoring to be used in urology practice ii. To pilot and test the impact of a culturally tailored, English and Spanish language version of the Prostate Choice in-visit decision aid on decision quality, knowledge, and quality of life in low-income Hispanic/Latino patients diagnosed with localized prostate cancer iii. To assess the barriers and facilitators of decision aid use including the relative contribution of language-concordance on 1-year practice implementation parameters.
- Conditions
- Prostate Cancer
- Being tested
- Decision Aid Tool, baseline survey, follow-up surveys
- Keywords
- decision aid, focus group
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Aid ToolBehavioural
Subjects will be given an I-pad with the decision aid program on it. A member of the study team will enter some preliminary information, then the subject will be able to review the tool with his doctor.
baseline surveyBehavioural
patients will be given baseline surveys to gather demographic information and readiness to make a decision regarding prostate cancer care
follow-up surveysBehavioural
at 3, 6, 9, and 12 months patients will be given follow-up surveys regarding prostate cancer care
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid | Experimental | Subjects will be asked to complete baseline surveys. Once the surveys are completed, subjects will review the Decision Aid tool with a study team member. Once the subjects have gone through the tool, study team members will answer any additional questions he may have regarding the tool. The subjects will then discuss with the investigator various cancer management options, quality of life implications, and any questions the subjects may have regarding cancer management options. Subjects that are ready may make a cancer management decision at this time, or choose to wait until their next scheduled visit. Subjects will be followed at subsequent urology clinic visits for up to 6 months. Subjects will complete follow-up surveys at the 3, 6, 9 and 12 month visits. Receives: Behavioral: Decision Aid Tool; Behavioral: baseline survey; Behavioral: follow-up surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision Quality of cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
Decisional quality will be measured by the O'Connor Decisional Conflict Scale
Measured: Up to 12 months
Knowledge of prostate cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
Prostate cancer knowledge will be measured by the Knowledge Measurement Tool
Measured: Up to 12 months
Patient satisfaction in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
Patient satisfaction will be measured by the CAPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) patient satisfaction measurement tool
Measured: Up to 12 months
Secondary outcomes (1)
Quality of Life in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
Health-related quality of life will be measured by the EPIC (Expanded Prostate Cancer Index Composite) assessment tool
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 Aug 2017
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Study Team did not respond to requests for continuing review approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon P Kim, MD, MPH, Principal investigator, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157947
- Sponsor's protocol ID
- CASE1817
- Status last verified
- Jul 2019
- First submitted
- 16 May 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of a Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer
- ClinicalTrials.gov ID
- NCT03157947
- Acronym / sponsor ID
- CASE1817
- Conditions
- Prostate Cancer
- Keywords
- decision aid, focus group
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study Team did not respond to requests for continuing review approval.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot study testing the effect of an in-visit English and Spanish language decision aid for Hispanic-Latino men using best practices of cultural tailoring to be used in urology practice. Subjects will be followed for approximately 1 year during standard care in-clinic office visits. Study results and subject surveys will be analyzed to determine clinical utility of the tool.
Detailed description
The objective of this research is to determine the effect of a culturally tailored decision aid tool on the cancer treatment decisions of Hispanic-Latino patients.
The specific aims are:
- To develop and pilot test in an uncontrolled fashion an in-visit English and Spanish language decision aid for Hispanic-Latino men using best practices of cultural tailoring to be used in urology practice ii. To pilot and test the impact of a culturally tailored, English and Spanish language version of the Prostate Choice in-visit decision aid on decision quality, knowledge, and quality of life in low-income Hispanic/Latino patients diagnosed with localized prostate cancer iii. To assess the barriers and facilitators of decision aid use including the relative contribution of language-concordance on 1-year practice implementation parameters.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decision Aid | Experimental | Behavioral: Decision Aid Tool, Behavioral: baseline survey, Behavioral: follow-up surveysSubjects will be asked to complete baseline surveys. Once the surveys are completed, subjects will review the Decision Aid tool with a study team member. Once the subjects have gone through the tool, study team members will answer any additional questions he may have regarding the tool. The subjects will then discuss with the investigator various cancer management options, quality of life implications, and any questions the subjects may have regarding cancer management options. Subjects that are ready may make a cancer management decision at this time, or choose to wait until their next scheduled visit. Subjects will be followed at subsequent urology clinic visits for up to 6 months. Subjects will complete follow-up surveys at the 3, 6, 9 and 12 month visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects utilize English or Spanish as their primary spoken or written language and identify with a Latino ethnicity and/or culture
- Men with a new histologic diagnosis of localized prostate cancer
- PSA level of 0.1 - 50 ng/dl
- Gleason score of 6 - 10
- Cancer stage: T1 - 4N x M0
Key exclusion criteria (4 listed)
- Metastatic disease, including lymph nodes or distant metastasis
- PSA > 50 ng/dl
- Individuals with a medical condition that necessitates a specific prostate cancer treatment plan
- Individuals that are unwilling or unable to attend study visits or are planning to move out of a study site coverage area during the subject's anticipated participation in the study
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 |
|---|---|---|
| Decision Aid ToolSubjects will be given an I-pad with the decision aid program on it. A member of the study team will enter some preliminary information, then the subject will be able to review the tool with his doctor. | Behavioural | Decision Aid |
| baseline surveypatients will be given baseline surveys to gather demographic information and readiness to make a decision regarding prostate cancer care | Behavioural | Decision Aid |
| follow-up surveysat 3, 6, 9, and 12 months patients will be given follow-up surveys regarding prostate cancer care | Behavioural | Decision Aid |
Primary outcome
Decision Quality of cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
Time frame: Up to 12 months
Decisional quality will be measured by the O'Connor Decisional Conflict Scale
Knowledge of prostate cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
Time frame: Up to 12 months
Prostate cancer knowledge will be measured by the Knowledge Measurement Tool
Patient satisfaction in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
Time frame: Up to 12 months
Patient satisfaction will be measured by the CAPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) patient satisfaction measurement tool
1 secondary outcome
Quality of Life in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
Time frame: Up to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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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.
Simon P Kim, MD, MPH principal investigator
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid Tool, baseline survey and follow-up surveys in people with Prostate Cancer, run by Case Comprehensive Cancer Center.
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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Decision Quality of cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer (time frame: Up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2019.