Prostatic NeoplasmsNCT02053389
Testing Decision Aids About Early Stage Prostate Cancer
A study testing DVD Decision Aid and Written decision aid in people with Prostatic Neoplasms, run by University of Michigan at 1 site in United States.
Trial summary
This is an educational intervention study testing the effects of decision aids in promoting patient participation in early stage prostate cancer treatment decision making. The purpose of this study is to compare patient-physician communication between patients who receive a DVD that models patient communication… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- DVD Decision Aid and Written decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 564 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Feb 2014
- 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
- Men aged 18 years and older
- Scheduled for a prostate biopsy to test for prostate cancer
- Ability to read and answer survey questions in English
Who cannot join
- Previous diagnosis of prostate cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Official title: Promoting Shared Decision Making in Prostate Cancer Through Decision Aids
This is an educational intervention study testing the effects of decision aids in promoting patient participation in early stage prostate cancer treatment decision making. The purpose of this study is to compare patient-physician communication between patients who receive a DVD that models patient communication strategies vs. those who do not receive a DVD. All patients will also receive a written decision aid that describes treatment options for early stage prostate cancer. The Investigators hypothesize that the DVD will:
- increase patients' perceptions of the importance of their preferences to their decision making
- increase patients' perceptions of their intention to discuss their values and preferences with their urologists and radiation oncologists
- increase patients' actual engagement with their physician during the clinical encounter
- increase the concordance between patient decision making preferences and actual decision making outcomes
- increase long term satisfaction with decision on type of treatment selected
- increase patient satisfaction with their decision and the decision making process
- influence patient perception of his physician (e.g., trust) and of the diagnosis visit
- Conditions
- Prostatic Neoplasms
- Being tested
- DVD Decision Aid, Written decision aid
- Keywords
- Patient-Physician communication, Decision Support Techniques, Health Communication, Physician-Patient Relationship, Decision Making
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVD Decision AidBehavioural
The decision aid, "Discussing the Choice: Talking with your Doctor about Early Stage Prostate Cancer" is a DVD modeling patient communication strategies. The DVD includes vignettes with actors depicting patient-physician discussions of prostate cancer treatments. In these vignettes, the patient models communication strategies designed to facilitate patient activation.
Written decision aidBehavioural
A written decision aid entitled "Making the Choice: Deciding What to Do About Early Stage Prostate Cancer" that describes treatment options for early stage prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| DVD Decision Aid | Experimental | Eligible participants receive the written decision aid ("Making the Choice: Deciding What to Do About Early Stage Prostate Cancer") AND the DVD decision aid ("Discussing the Choice: Talking with your Doctor about Early Stage Prostate Cancer"), which provides instruction and recommendations on how to participate in shared decision making with one's physician. Receives: Behavioral: DVD Decision Aid |
| Written Decision Aid | Active comparator | Eligible participants receive the written decision aid ("Making the Choice: Deciding What to Do About Early Stage Prostate Cancer") alone. Receives: Behavioral: Written decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy for discussing preferences (intention)
14 item survey instrument
Measured: Time 1 (baseline)
Self-efficacy for discussing preferences (intention)
14 item survey instrument
Measured: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Self-efficacy for discussing preferences (actual)
14 item survey instrument
Measured: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Secondary outcomes (15)
Preference for shared decision making
1 item survey instrument
Measured: Time 1 (baseline)
Preference for shared decision making
1 item survey instrument
Measured: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Prostate cancer related knowledge
10 item survey instrument
Measured: Time 1 (baseline)
Prostate cancer related knowledge
10 item survey instrument
Measured: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Prostate cancer related knowledge
12 item survey instrument
Measured: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Prostate cancer related anxiety
6 item survey instrument
Measured: Time 1 (baseline)
Prostate cancer related anxiety
6 item survey instrument
Measured: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Prostate cancer related anxiety
6 item survey instrument
Measured: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Prostate cancer related anxiety
7 item survey instrument
Measured: Time 4 (6 months post diagnosis)
Treatment preference
1 item survey instrument
Measured: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Treatment decision
2 item survey instrument
Measured: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Treatment decision
2 item survey instrument
Measured: Time 4 (6 months post diagnosis)
Decisional regret
5 item survey instrument
Measured: Time 4 (6 months post diagnosis)
Preference for shared decision making
1 item survey instrument
Measured: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Preference for shared decision making
1 item survey instrument
Measured: Time 4 (6 months post diagnosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startNov 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 564 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Angela Fagerlin, University of Michigan
- Investigators
- Angela T Fagerlin, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053389
- Sponsor's protocol ID
- F021723 - 060077
- Other IDs
- P50CA101451-10
- Status last verified
- May 2015
- First submitted
- 19 Dec 2013
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fridman I, Ubel PA, Kahn VC, Fagerlin A. Association of quantitative information and patient knowledge about prostate cancer outcomes. Health Psychol. 2022 Jul;41(7):484-491. doi: 10.1037/hea0001196.
PubMed 35727324
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Shared Decision Making in Prostate Cancer Through Decision Aids
- ClinicalTrials.gov ID
- NCT02053389
- Acronym / sponsor ID
- F021723 - 060077
- Conditions
- Prostatic Neoplasms
- Keywords
- Patient-Physician communication, Decision Support Techniques, Health Communication, Physician-Patient Relationship, Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 3 Feb 2014 (estimated)
- 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.
This is an educational intervention study testing the effects of decision aids in promoting patient participation in early stage prostate cancer treatment decision making. The purpose of this study is to compare patient-physician communication between patients who receive a DVD that models patient communication strategies vs. those who do not receive a DVD. All patients will also receive a written decision aid that describes treatment options for early stage prostate cancer. The Investigators hypothesize that the DVD will:
- increase patients' perceptions of the importance of their preferences to their decision making
- increase patients' perceptions of their intention to discuss their values and preferences with their urologists and radiation oncologists
- increase patients' actual engagement with their physician during the clinical encounter
- increase the concordance between patient decision making preferences and actual decision making outcomes
- increase long term satisfaction with decision on type of treatment selected
- increase patient satisfaction with their decision and the decision making process
- influence patient perception of his physician (e.g., trust) and of the diagnosis visit
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DVD Decision Aid | Experimental | Behavioral: DVD Decision AidEligible participants receive the written decision aid ("Making the Choice: Deciding What to Do About Early Stage Prostate Cancer") AND the DVD decision aid ("Discussing the Choice: Talking with your Doctor about Early Stage Prostate Cancer"), which provides instruction and recommendations on how to participate in shared decision making with one's physician. |
| Written Decision Aid | Active comparator | Behavioral: Written decision aidEligible participants receive the written decision aid ("Making the Choice: Deciding What to Do About Early Stage Prostate Cancer") alone. |
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)
- Men aged 18 years and older
- Scheduled for a prostate biopsy to test for prostate cancer
- Ability to read and answer survey questions in English
Key exclusion criteria (1 listed)
- Previous diagnosis of prostate cancer
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 |
|---|---|---|
| DVD Decision AidThe decision aid, "Discussing the Choice: Talking with your Doctor about Early Stage Prostate Cancer" is a DVD modeling patient communication strategies. The DVD includes vignettes with actors depicting patient-physician discussions of prostate cancer treatments. In these vignettes, the patient models communication strategies designed to facilitate patient activation. | Behavioural | DVD Decision Aid |
| Written decision aidA written decision aid entitled "Making the Choice: Deciding What to Do About Early Stage Prostate Cancer" that describes treatment options for early stage prostate cancer. | Behavioural | Written Decision Aid |
Primary outcome
Self-efficacy for discussing preferences (intention)
Time frame: Time 1 (baseline)
14 item survey instrument
Self-efficacy for discussing preferences (intention)
Time frame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
14 item survey instrument
Self-efficacy for discussing preferences (actual)
Time frame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
14 item survey instrument
15 secondary outcomes
Preference for shared decision making
Time frame: Time 1 (baseline)
Preference for shared decision making
Time frame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Prostate cancer related knowledge
Time frame: Time 1 (baseline)
Prostate cancer related knowledge
Time frame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Prostate cancer related knowledge
Time frame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Prostate cancer related anxiety
Time frame: Time 1 (baseline)
Prostate cancer related anxiety
Time frame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Prostate cancer related anxiety
Time frame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Prostate cancer related anxiety
Time frame: Time 4 (6 months post diagnosis)
Treatment preference
Time frame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)
Treatment decision
Time frame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Treatment decision
Time frame: Time 4 (6 months post diagnosis)
Decisional regret
Time frame: Time 4 (6 months post diagnosis)
Preference for shared decision making
Time frame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)
Preference for shared decision making
Time frame: Time 4 (6 months post diagnosis)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Derived from this study: PubMed 35727324Fridman I, Ubel PA, Kahn VC, Fagerlin A. Association of quantitative information and patient knowledge about prostate cancer outcomes. Health Psychol. 2022 Jul;41(7):484-491. doi: 10.1037/hea0001196.
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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.
Angela T Fagerlin, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DVD Decision Aid and Written decision aid in people with Prostatic Neoplasms, run by University of Michigan at 1 site 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 1 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 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-efficacy for discussing preferences (intention) (time frame: Time 1 (baseline)). 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?
On the ClinicalTrials.gov record for NCT02053389, 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 1 Jun 2015.