<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01673581</url>
  </required_header>
  <id_info>
    <org_study_id>11-463</org_study_id>
    <nct_id>NCT01673581</nct_id>
  </id_info>
  <brief_title>Shared Decision Making in Low Risk Prostate Cancer</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the usefulness of an informational website designed to educate&#xD;
      patients with prostate cancer about their options for treatment. The investigators hope that&#xD;
      this website will assist patients with making informed decisions about their care and&#xD;
      improving their satisfaction with the treatments they choose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators will first ask patients to answer a series of questions to assess their wishes&#xD;
      regarding treatment, knowledge about their disease and discussion with the physicians at&#xD;
      initial patient visit. This initial survey should take approximately 20 minutes. Once&#xD;
      patients have selected a treatment path investigators will contact them again and ask them to&#xD;
      fill out a short 10-minute survey online or by mail. Investigators will contact patients by&#xD;
      phone 2 weeks after their initial visit to see if they have made a decision. If not,&#xD;
      investigators will contact patients by phone every 2 weeks or at an interval that works for&#xD;
      the patient's schedule. Finally, 3 months after the initial visit today investigators will&#xD;
      contact patients for the last time and again ask you to fill out a short 10-minute survey&#xD;
      online or by mail.&#xD;
&#xD;
      Once patients have completed the final survey there are no future surveys planned.&#xD;
      Investigators may contact patients by phone in the future to ask them to participate in&#xD;
      another study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient knowledge regarding the available treatment options for low-risk prostate cancer and their potential side effects.</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decisional conflict and informed decision making experienced by patients.</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient health related worry.</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient views on cancer control for their treatment choice.</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with their treatment choice.</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">141</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Low risk prostate cancer</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey</intervention_name>
    <arm_group_label>Low risk prostate cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Low risk prostate cancer patients seen wthin the Claire &amp; John Bertucci Center for&#xD;
        Genitourinary Cancers multidisciplinary clinic at MGH.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed prostate adenocarcinoma&#xD;
&#xD;
          -  Internet access&#xD;
&#xD;
          -  Able to read and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of nodal metastases&#xD;
&#xD;
          -  Evidence of distant metastases&#xD;
&#xD;
          -  Prior surgery, chemotherapy, pelvic radiation or prostate brachytherapy for prostate&#xD;
             cancer&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason A. Efstathiou, MD, DPhil</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>August 22, 2019</last_update_submitted>
  <last_update_submitted_qc>August 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Jason Efstathiou</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Low Risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01673581
org study id: 11-463
nct id: NCT01673581
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Patient knowledge regarding the available treatment options for low-risk prostate cancer and their potential side effects.
time frame: 2 years
description: 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.
measure: Decisional conflict and informed decision making experienced by patients.
time frame: 2 years
description: 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.
measure: Patient health related worry.
time frame: 2 years
description: 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.
measure: Patient views on cancer control for their treatment choice.
time frame: 2 years
description: 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.
measure: Patient satisfaction with their treatment choice.
time frame: 2 years
description: 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.
arm group label: Low risk prostate cancer
intervention type: Other
intervention name: Survey
arm group label: Low risk prostate cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jason A. Efstathiou, MD, DPhil
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Jason Efstathiou
investigator title: Principal Investigator
mesh term: Prostatic Neoplasms