Prostate CancerNCT01673581
Shared Decision Making in Low Risk Prostate Cancer
An observational study of Prostate Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will evaluate the usefulness of an informational website designed to educate patients with prostate cancer about their options for treatment. The investigators hope that this website will assist patients with making informed decisions about their care and improving their satisfaction with the treatments… 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?
- Survey
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 5 Jun 2020
- Phase
- Observational
- 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
Study population: Low risk prostate cancer patients seen wthin the Claire \& John Bertucci Center for Genitourinary Cancers multidisciplinary clinic at MGH.
Who may be able to join
- Histologically confirmed prostate adenocarcinoma
- Internet access
- Able to read and understand English
Who cannot join
- Evidence of nodal metastases
- Evidence of distant metastases
- Prior surgery, chemotherapy, pelvic radiation or prostate brachytherapy for prostate cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Shared Decision Making: A Study Assessing the Benefit of a Web Based Aid Presenting Treatment Options for Patients With Low Risk Prostate Cancer
This study will evaluate the usefulness of an informational website designed to educate patients with prostate cancer about their options for treatment. The investigators hope that this website will assist patients with making informed decisions about their care and improving their satisfaction with the treatments they choose.
Read the detailed description
Investigators will first ask patients to answer a series of questions to assess their wishes regarding treatment, knowledge about their disease and discussion with the physicians at initial patient visit. This initial survey should take approximately 20 minutes. Once patients have selected a treatment path investigators will contact them again and ask them to fill out a short 10-minute survey online or by mail. Investigators will contact patients by phone 2 weeks after their initial visit to see if they have made a decision. If not, investigators will contact patients by phone every 2 weeks or at an interval that works for the patient's schedule. Finally, 3 months after the initial visit today investigators will contact patients for the last time and again ask you to fill out a short 10-minute survey online or by mail.
Once patients have completed the final survey there are no future surveys planned. Investigators may contact patients by phone in the future to ask them to participate in another study.
- Conditions
- Prostate Cancer
- Being tested
- Survey
- Keywords
- Low Risk
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
| Study group | Role | What they receive |
|---|---|---|
| Low risk prostate cancer | Not described Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient knowledge regarding the available treatment options for low-risk prostate cancer and their potential side effects.
Investigators will assess the impact of an informational website developed specifically to assist low-risk prostate cancer patients with knowledge of their disease and treatment options. This will be measured by patient responses to questionnaires compiled from validated sources.
Measured: 2 years
Secondary outcomes (4)
Decisional conflict and informed decision making experienced by patients.
Investigators will assess the impact of an informational website developed specifically to assist low-risk prostate cancer patients with knowledge of their disease and treatment options. This will be measured by patient responses to questionnaires compiled from validated sources.
Measured: 2 years
Patient health related worry.
Investigators will assess the impact of an informational website developed specifically to assist low-risk prostate cancer patients with knowledge of their disease and treatment options. This will be measured by patient responses to questionnaires compiled from validated sources.
Measured: 2 years
Patient views on cancer control for their treatment choice.
Investigators will assess the impact of an informational website developed specifically to assist low-risk prostate cancer patients with knowledge of their disease and treatment options. This will be measured by patient responses to questionnaires compiled from validated sources.
Measured: 2 years
Patient satisfaction with their treatment choice.
Investigators will assess the impact of an informational website developed specifically to assist low-risk prostate cancer patients with knowledge of their disease and treatment options. This will be measured by patient responses to questionnaires compiled from validated sources.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startAug 2012
- Primary completion5 Jun 2020
- Study completion5 Jun 2020
Why it stopped: Due to unforeseen changes in study personnel, the study was not initiated.
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 Massachusetts General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Efstathiou, Massachusetts General Hospital
- Investigators
- Jason A. Efstathiou, MD, DPhil, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673581
- Sponsor's protocol ID
- 11-463
- Status last verified
- May 2026
- First submitted
- 15 Aug 2012
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making: A Study Assessing the Benefit of a Web Based Aid Presenting Treatment Options for Patients With Low Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT01673581
- Acronym / sponsor ID
- 11-463
- Conditions
- Prostate Cancer
- Keywords
- Low Risk
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to unforeseen changes in study personnel, the study was not initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 28 Aug 2012 (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 study will evaluate the usefulness of an informational website designed to educate patients with prostate cancer about their options for treatment. The investigators hope that this website will assist patients with making informed decisions about their care and improving their satisfaction with the treatments they choose.
Detailed description
Investigators will first ask patients to answer a series of questions to assess their wishes regarding treatment, knowledge about their disease and discussion with the physicians at initial patient visit. This initial survey should take approximately 20 minutes. Once patients have selected a treatment path investigators will contact them again and ask them to fill out a short 10-minute survey online or by mail. Investigators will contact patients by phone 2 weeks after their initial visit to see if they have made a decision. If not, investigators will contact patients by phone every 2 weeks or at an interval that works for the patient's schedule. Finally, 3 months after the initial visit today investigators will contact patients for the last time and again ask you to fill out a short 10-minute survey online or by mail.
Once patients have completed the final survey there are no future surveys planned. Investigators may contact patients by phone in the future to ask them to participate in another study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low risk prostate cancer | – | Other: Survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Low risk prostate cancer patients seen wthin the Claire \& John Bertucci Center for Genitourinary Cancers multidisciplinary clinic at MGH.
Key inclusion criteria (3 listed)
- Histologically confirmed prostate adenocarcinoma
- Internet access
- Able to read and understand English
Key exclusion criteria (3 listed)
- Evidence of nodal metastases
- Evidence of distant metastases
- Prior surgery, chemotherapy, pelvic radiation or prostate brachytherapy for 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 |
|---|---|---|
| Survey | Other | Low risk prostate cancer |
Primary outcome
Patient knowledge regarding the available treatment options for low-risk prostate cancer and their potential side effects.
Time frame: 2 years
Investigators will assess the impact of an informational website developed specifically to assist low-risk prostate cancer patients with knowledge of their disease and treatment options. This will be measured by patient responses to questionnaires compiled from validated sources.
4 secondary outcomes
Decisional conflict and informed decision making experienced by patients.
Time frame: 2 years
Patient health related worry.
Time frame: 2 years
Patient views on cancer control for their treatment choice.
Time frame: 2 years
Patient satisfaction with their treatment choice.
Time frame: 2 years
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 15 May 2026.
Related trials for Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Active, not recruitingPhase 3
Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer
Stage II Prostate Adenocarcinoma AJCC v7
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
RecruitingPhase 1
Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT
Advanced Prostate Cancer, Metastatic Prostate Cancer
RecruitingPhase 1
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
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.
Jason A. Efstathiou, MD, DPhil principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Massachusetts General Hospital 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 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: withdrawn, as of the sponsor's last update on 15 May 2026. 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 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?
Patient knowledge regarding the available treatment options for low-risk prostate cancer and their potential side effects. (time frame: 2 years). 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 15 May 2026.