Prostate CancerNCT03182998
Decision Aids to Improve Knowledge in Patients With Prostate Cancer
A study testing Internet-Based Intervention, Best Practice and Quality-of-Life Assessment in people with Prostate Cancer, run by Mayo Clinic at 5 sites in United States.
Trial summary
This randomized phase III trial studies how well decision aids work in improving knowledge in patients with prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor. 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?
- Internet-Based Intervention, Best Practice and Quality-of-Life Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Jul 2017to 4 Feb 2022
- 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
- Patients must have prostate biopsy within 4 months prior to registration showing newly diagnosed prostate cancer, stage T1-3N0M0; in addition, patients must have: Gleason score 6-10
- Prostate-specific antigen (PSA) < 50 ng/mL
- Patients who have had a history of non-cutaneous malignancy in the previous 5 years are not eligible; exception: patients with history of non-melanoma skin cancer are eligible
- Scheduled prostate cancer consultation to be the first consultation after diagnosis (i.e. not a second-opinion or a consultation following previous discussions of treatment options)
- Patients may not be concurrently enrolled to another clinical trial for the treatment of cancer; co-enrollment to biospecimen studies is allowed
- Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
- Patients must be able to read and comprehend English; non-English-speaking patients may participate so long as an interpreter (e.g., family member, clinic staff, etc.) is present for consent, for the decision aid administration, and gathering of baseline and follow-up measures
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Alaska Native Tribal Health Consortium
Anchorage, Alaska, 99508
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Metrohealth Medical Center Urology Institute
Cleveland, Ohio, 44109
Regional Health
Rapid City, South Dakota, 57701
Mayo Clinic
Scottsdale, Arizona, 85259
About this study
Official title: Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men
This randomized phase III trial studies how well decision aids work in improving knowledge in patients with prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.
- Conditions
- Prostate Cancer
- Being tested
- Internet-Based Intervention, Best Practice, Quality-of-Life Assessment, Questionnaire Administration, Survey Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based InterventionOther
Receive "Knowing your Options" decision aid
Internet-Based InterventionOther
Receive "Prostate Choice" decision aid
Best PracticeOther
Also called best practice, Best Practice, standard of care, standard therapy
Undergo usual care
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment, Quality-of-Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Knowing Your Options) | Experimental | Arm A ("Knowing your Options") Patients receive "Knowing your Options" decision aid before their consultation visit. Receives: Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration; Other: Laboratory Biomarker Analysis |
| Arm B (Prostate Choice) | Experimental | Patients receive "Prostate Choice" decision aid during their consultation visit. Receives: Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration; Other: Laboratory Biomarker Analysis |
| Arm C (Usual Care) | Active comparator | Patients undergo usual care. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge Assessed by Prostate Cancer Treatment Questionnaire
The primary outcome, knowledge, will be assessed by a standardized questionnaire (i.e., Prostate Cancer Treatment Questionnaire) administered once, immediately after the clinical consultation while the patient is still at the study site. The number correct from this 12-item measure will be reduced to a proportion of total number correct. With 1.0 (12 out of 12 item average) being the best possible outcome and 0.0 (0 out of 12 item average) the worst possible outcome
Measured: 12 months
Secondary outcomes (3)
Decisional Quality as Measured by Decisional Regret Scale
The Decisional Regret Scale is a short, 5-item scale measuring "distress or remorse after a (health care) decision." The instrument has been validated in other decision aid studies. Questions are answered on a 5-point agreement scale. A score of 0 means no decisional regret and 5 is the maximum level of regret. The continuous scores were then grouped into two categories, 0 (no regret) and 1+ (at least some regret).
Measured: 12 months
Quality of Life Assessed by Questionnaire
The Expanded Prostate Cancer Index Composit (EPIC-26) measures health-related quality of life and returns summary scores for urinary, bowel, sexual, and hormonal domains with high test-retest reliability and internal consistency. Scores will be converted into continuous summary scores using standard algorithms. For the EPIC-26 questionnaire, scores were transformed into 0 to 100 scales, with a score of 0 represented the worst possible health-related quality of life and a score of 100 representing the most favorable health-related quality of life. The questionnaire will be administered once; 12 months after the patient's initial consultation.
Measured: 12 months
Utilization as Determined by Chart Review
Will be categorized by the type of treatment the patient elected to receive. Will be compared across intervention arms.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start14 Jul 2017
- Primary completion4 Feb 2022
- Study completion4 Feb 2022
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.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Jon C. Tilburt, Mayo Clinic
- Investigators
- Jon C. Tilburt, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182998
- Sponsor's protocol ID
- 16-010459
- Other IDs
- R01MD008934-05
- Status last verified
- Jul 2023
- First submitted
- 8 Jun 2017
- Last updated
- 2 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men
- ClinicalTrials.gov ID
- NCT03182998
- Acronym / sponsor ID
- 16-010459
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Posted 2 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase III trial studies how well decision aids work in improving knowledge in patients with prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A (Knowing Your Options) | Experimental | Other: Internet-Based Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Survey Administration, Other: Laboratory Biomarker AnalysisArm A ("Knowing your Options") Patients receive "Knowing your Options" decision aid before their consultation visit. |
| Arm B (Prostate Choice) | Experimental | Other: Internet-Based Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Survey Administration, Other: Laboratory Biomarker AnalysisPatients receive "Prostate Choice" decision aid during their consultation visit. |
| Arm C (Usual Care) | Active comparator | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Survey Administration, Other: Laboratory Biomarker AnalysisPatients undergo usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have prostate biopsy within 4 months prior to registration showing newly diagnosed prostate cancer, stage T1-3N0M0; in addition, patients must have: Gleason score 6-10
- Prostate-specific antigen (PSA) < 50 ng/mL
- Patients who have had a history of non-cutaneous malignancy in the previous 5 years are not eligible; exception: patients with history of non-melanoma skin cancer are eligible
- Scheduled prostate cancer consultation to be the first consultation after diagnosis (i.e. not a second-opinion or a consultation following previous discussions of treatment options)
- Patients may not be concurrently enrolled to another clinical trial for the treatment of cancer; co-enrollment to biospecimen studies is allowed
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Internet-Based InterventionReceive "Knowing your Options" decision aid | Other | Arm A (Knowing Your Options) |
| Internet-Based InterventionReceive "Prostate Choice" decision aid | Other | Arm B (Prostate Choice) |
| Best PracticeAlso: best practice, Best Practice, standard of care, standard therapyUndergo usual care | Other | Arm C (Usual Care) |
| Quality-of-Life AssessmentAlso: Quality of Life Assessment, Quality-of-Life AssessmentAncillary studies | Other | Arm A (Knowing Your Options), Arm B (Prostate Choice), Arm C (Usual Care) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (Knowing Your Options), Arm B (Prostate Choice), Arm C (Usual Care) |
| Survey AdministrationAncillary studies | Other | Arm A (Knowing Your Options), Arm B (Prostate Choice), Arm C (Usual Care) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm A (Knowing Your Options), Arm B (Prostate Choice), Arm C (Usual Care) |
Primary outcome
Knowledge Assessed by Prostate Cancer Treatment Questionnaire
Time frame: 12 months
The primary outcome, knowledge, will be assessed by a standardized questionnaire (i.e., Prostate Cancer Treatment Questionnaire) administered once, immediately after the clinical consultation while the patient is still at the study site. The number correct from this 12-item measure will be reduced to a proportion of total number correct. With 1.0 (12 out of 12 item average) being the best possible outcome and 0.0 (0 out of 12 item average) the worst possible outcome
3 secondary outcomes
Decisional Quality as Measured by Decisional Regret Scale
Time frame: 12 months
Quality of Life Assessed by Questionnaire
Time frame: 12 months
Utilization as Determined by Chart Review
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
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Not yet recruitingPhase 3
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Prostatic Neoplasms
RecruitingPhase 1/2
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RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
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RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
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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.
Jon C. Tilburt, M.D. principal investigator
Mayo Clinic
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Intervention, Best Practice and Quality-of-Life Assessment in people with Prostate Cancer, run by Mayo Clinic at 5 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 7 inclusion and 0 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 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 2 Aug 2023). 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?
Knowledge Assessed by Prostate Cancer Treatment Questionnaire (time frame: 12 months). 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 2 Aug 2023.