xml: <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/NCT06011434</url>
    </required_header>
    <id_info>
      <org_study_id>23-201</org_study_id>
      <secondary_id>R01AG065311</secondary_id>
      <nct_id>NCT06011434</nct_id>
    </id_info>
    <brief_title>Testing Conversation Aid in Practice</brief_title>
    <official_title>Testing a Conversation Aid on Mammography Screening for Clinicians and Women 75 and Older in Practice</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beth Israel Deaconess Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Beth Israel Deaconess Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this research study is to develop and test a website to help primary care&#xD;
        providers (PCPs) discuss the pros and cons of mammography with women aged 75 and older and to&#xD;
        help participants make decisions about mammography.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This research study is to conduct a pilot pretest-posttest trial to learn if providing a&#xD;
        web-based conversation aid (CA) on mammography screening to 36 primary care providers&#xD;
        facilitates shared decision making (SDM) and 8 medical assistants with 190 of their patients&#xD;
        (2-3 per PCP) aged 75-89 years and 23 involved family members.&#xD;
  &#xD;
        Research procedures include screening for eligibility, questionnaires, and clinic visits.&#xD;
  &#xD;
        Participation in this research study is expected to last about 4 months.&#xD;
  &#xD;
        It is expected about 90 participants, 23 participant family members, 36 primary care&#xD;
        providers, and 8 medical assistants will participant in this research study.&#xD;
  &#xD;
        The National Institute on Aging is supporting this research study by providing funding.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 2024</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2025</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>Intentions For Screening Questionnaire</measure>
      <time_frame>1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.</time_frame>
      <description>Assessed by the Intentions for Screening questionnaire, a 15-point validated measure (1 to 15) to assess one's leaning towards an option with scores of 1=no, 8= unsure, and 15=yes.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Shared Decision Making (SDM) Questionnaire</measure>
      <time_frame>1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.</time_frame>
      <description>Assessed by the validated, 9-item SDM questionnaire. Each item will be scored on a 6-point Likert scale with answers ranging from 0 &quot;completely disagree&quot; to 6 &quot;completely agree.&quot; A total score will range from 9 - 54.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Decisional Conflict Questionnaire</measure>
      <time_frame>1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.</time_frame>
      <description>Assessed by the Decisional Conflict Questionnaire, a validated, 16 item scale scored on a 5-point Likert scale. Answers range from 1 &quot;Strongly Agree&quot; to 0 &quot;Neutral&quot; to 4 &quot; Strongly Agree&quot; with each score ranging from 0 - 4 points. A total is calculated by [sum of scores/16] x 25=scale 0-100).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Role In Decision (Decision Making Preferences Questionnaire)</measure>
      <time_frame>1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.</time_frame>
      <description>Controlled preferences scale Assessed by the Decision Making Preferences questionnaire which includes 5 response categories (see comments). We will group the 5-items into 3 categories (patient prefers to make the decision, patient prefers the PCP makes the final decision, the patient prefers to share the decision with the PCP). This scale is commonly used to assess a participant's preferred involvement in decision making.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant Knowledge Questionnaire</measure>
      <time_frame>1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.</time_frame>
      <description>Assessed by the participant knowledge questionnaire, comprised of 10 True/False questions. Total score will be reported as a mean percentage of the number of questions answered correctly.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mammogram Attitudes Questionnaire</measure>
      <time_frame>1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.</time_frame>
      <description>Assessed by the mammogram attitudes questionnaire, comprised of 3 questions graded on a 7-point Likert scale with answers ranging from 1 &quot;Completely Unnecessary/Harmful/Unpleasant&quot; to 7 &quot;Completely Necessary/Beneficial/Pleasant. Scores will be summed and a total score will range from 3 - 21.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mammogram Perceived Norms Questionnaire</measure>
      <time_frame>1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.</time_frame>
      <description>Assessed by the mammogram norms questionnaire, comprised of 2 questions graded on a 7-point Likert scale with answers ranging from 1 &quot;Strongly Disagree&quot; to 7 &quot;Strongly Agree.&quot; Scores will be summed and a total score will range from 2 - 14.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinician Self-Efficacy Scale</measure>
      <time_frame>1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.</time_frame>
      <description>Assessed by the clinician self-efficacy subscale of the Shared Decision Making (SDM) Questionnaire, which measures clinician self-efficacy to engage older women in shared decision making around mammography screening and is comprised of 5 questions graded on a 7-point Likert scale with answers ranging from 1 &quot;Strongly Disagree/Easy&quot; to 7 &quot;Strongly Agree/Difficult.&quot; A total score will range from 5 to 35.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinician Attitudes Scale</measure>
      <time_frame>1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.</time_frame>
      <description>Assessed by the clinician attitudes Subscale of the Share Decision Making (SDM Questionnaire which is comprised of 4 questions about clinician attitudes towards mammography screening and graded on a 7-point Likert scale with scores ranging from &quot;1 &quot;Unnecessary/Harmful/Unpleasant/Worthless&quot; to 7 &quot;Necessary/Beneficial/Pleasant/Useful.&quot; A total score will range from 4 - 28.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinician Perceived Norms Scale</measure>
      <time_frame>1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.</time_frame>
      <description>Assessed by the clinician perceived norms subscale of the Shared Decision Making (SDM) Questionnaire which is comprised of 4 questions about clinician perceived norms around mammography screening and graded on a 7-point Likert scale with answers ranging from 1 &quot;Strongly Disagree&quot; to 7 &quot;Strongly Agree.&quot; A total score will range from 4 - 28.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">157</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Patient: Conversation Aid On Mammography Screening</arm_group_label>
      <description>Participants will complete study procedures as follows:&#xD;
  Pretest questionnaires.&#xD;
  PCP Appointment with introduction to conversation aid website.&#xD;
  Post-test questionnaires within two weeks of PCP visit.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Family: Conversation Aid On Mammography Screening</arm_group_label>
      <description>Caretakers/Family members to participants will complete study procedures as follows:&#xD;
  Pretest questionnaires.&#xD;
  Attend with participant PCP Appointment with introduction to conversation aid website.&#xD;
  Post-test questionnaires within two weeks of PCP visit.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Clinician: Conversation Aid On Mammography Screening</arm_group_label>
      <description>Clinicians will complete study procedures as follows:&#xD;
  Pretest questionnaires.&#xD;
  Post-test questionnaires.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mammography Screening Conversation Aid</intervention_name>
      <description>Web-based, &quot;Decide Together&quot; conversation aid designed to be used by PCP and participant for shared decision making and to provide information on the benefits and harms of mammography screening as well as educational talking points.</description>
      <arm_group_label>Clinician: Conversation Aid On Mammography Screening</arm_group_label>
      <arm_group_label>Family: Conversation Aid On Mammography Screening</arm_group_label>
      <arm_group_label>Patient: Conversation Aid On Mammography Screening</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Primary care practices at Beth Israel Deaconess Medical Center&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Participant Inclusion Criteria:&#xD;
  &#xD;
            -  English-speaking&#xD;
  &#xD;
            -  Aged 75 - 89 years&#xD;
  &#xD;
            -  Seen by an attending-level (non-resident) seen at the recruitment practices who have&#xD;
               the -Ability and willingness to provide verbal consent.&#xD;
  &#xD;
          Participant Family Members Inclusion Criteria:&#xD;
  &#xD;
            -  Family member of patient that has agreed to participate in the study&#xD;
  &#xD;
            -  Age &gt;18&#xD;
  &#xD;
            -  English speaking&#xD;
  &#xD;
            -  Ability and willingness to provide verbal consent&#xD;
  &#xD;
          Primary Care Provider Inclusion Criteria:&#xD;
  &#xD;
            -  Non-resident physician, nurse practitioner, or physician assistant&#xD;
  &#xD;
               -&gt;18 years old&#xD;
  &#xD;
            -  English speaking&#xD;
  &#xD;
            -  Cares for a panel of patients that includes women &gt;75 years at one of the recruitment&#xD;
               practices&#xD;
  &#xD;
            -  Ability and willingness to provide verbal consent&#xD;
  &#xD;
          Participant Exclusion Criteria:&#xD;
  &#xD;
            -  Last mammogram &lt;6 or &gt;30 months (so that participants may be contemplative of their&#xD;
               next mammogram)&#xD;
  &#xD;
            -  History of dementia&#xD;
  &#xD;
            -  Incapacity for informed consent&#xD;
  &#xD;
            -  History of invasive or non-invasive breast cancer&#xD;
  &#xD;
            -  Last mammogram was abnormal&#xD;
  &#xD;
            -  Non-English speaking&#xD;
  &#xD;
            -  Already chose to stop being screened (documented in medical records or scores of 1-3&#xD;
               [do not intend to be screened] on a validate 15 point intentions to be screened&#xD;
               scale.)&#xD;
  &#xD;
            -  PCP unwilling to have patient participate&#xD;
  &#xD;
            -  In hospice&#xD;
  &#xD;
            -  PCP not willing to participate&#xD;
  &#xD;
            -  Psychiatric illness situations that would limit compliance with study requirements&#xD;
  &#xD;
          Participant Family Member Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;18&#xD;
  &#xD;
            -  Non-English speaking&#xD;
  &#xD;
            -  Psychiatric illness situations that would limit compliance with study requirements&#xD;
  &#xD;
          Primary Care Provider Exclusion Criteria:&#xD;
  &#xD;
            -  Resident physician&#xD;
  &#xD;
            -  Psychiatric illness situations that would limit compliance with study requirements&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>75 Years</minimum_age>
      <maximum_age>89 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mara Schonberg, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Beth Israel Deaconess Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mara Schonberg, MD, MPH</last_name>
      <phone>617-754-1414</phone>
      <email>mschonbe@bidmc.harvard.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beth Israel Deaconess Medical Center</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02215</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Mara Schonberg, MD, MPH</last_name>
        <phone>617-754-1414</phone>
        <email>mschonbe@bidmc.harvard.edu</email>
      </contact>
      <investigator>
        <last_name>Mara Schonberg, MD, MPH</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
      <investigator_full_name>Mara Schonberg</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Breast Cancer</keyword>
    <keyword>Mammography</keyword>
    <keyword>Breast Cancer Screening</keyword>
    <keyword>Mammography Screening</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication</ipd_time_frame>
      <ipd_access_criteria>Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011434
  org study id: 23-201
  secondary id: R01AG065311
  nct id: NCT06011434
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this research study is to develop and test a website to help primary care
        providers (PCPs) discuss the pros and cons of mammography with women aged 75 and older and to
        help participants make decisions about mammography.
  This research study is to conduct a pilot pretest-posttest trial to learn if providing a
        web-based conversation aid (CA) on mammography screening to 36 primary care providers
        facilitates shared decision making (SDM) and 8 medical assistants with 190 of their patients
        (2-3 per PCP) aged 75-89 years and 23 involved family members.
  
        Research procedures include screening for eligibility, questionnaires, and clinic visits.
  
        Participation in this research study is expected to last about 4 months.
  
        It is expected about 90 participants, 23 participant family members, 36 primary care
        providers, and 8 medical assistants will participant in this research study.
  
        The National Institute on Aging is supporting this research study by providing funding.
  observational model: Cohort
  time perspective: Prospective
  measure: Intentions For Screening Questionnaire
  time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
  description: Assessed by the Intentions for Screening questionnaire, a 15-point validated measure (1 to 15) to assess one's leaning towards an option with scores of 1=no, 8= unsure, and 15=yes.
  measure: Shared Decision Making (SDM) Questionnaire
  time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
  description: Assessed by the validated, 9-item SDM questionnaire. Each item will be scored on a 6-point Likert scale with answers ranging from 0 "completely disagree" to 6 "completely agree." A total score will range from 9 - 54.
  measure: Decisional Conflict Questionnaire
  time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
  description: Assessed by the Decisional Conflict Questionnaire, a validated, 16 item scale scored on a 5-point Likert scale. Answers range from 1 "Strongly Agree" to 0 "Neutral" to 4 " Strongly Agree" with each score ranging from 0 - 4 points. A total is calculated by [sum of scores/16] x 25=scale 0-100).
  measure: Role In Decision (Decision Making Preferences Questionnaire)
  time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
  description: Controlled preferences scale Assessed by the Decision Making Preferences questionnaire which includes 5 response categories (see comments). We will group the 5-items into 3 categories (patient prefers to make the decision, patient prefers the PCP makes the final decision, the patient prefers to share the decision with the PCP). This scale is commonly used to assess a participant's preferred involvement in decision making.
  measure: Participant Knowledge Questionnaire
  time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
  description: Assessed by the participant knowledge questionnaire, comprised of 10 True/False questions. Total score will be reported as a mean percentage of the number of questions answered correctly.
  measure: Mammogram Attitudes Questionnaire
  time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
  description: Assessed by the mammogram attitudes questionnaire, comprised of 3 questions graded on a 7-point Likert scale with answers ranging from 1 "Completely Unnecessary/Harmful/Unpleasant" to 7 "Completely Necessary/Beneficial/Pleasant. Scores will be summed and a total score will range from 3 - 21.
  measure: Mammogram Perceived Norms Questionnaire
  time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
  description: Assessed by the mammogram norms questionnaire, comprised of 2 questions graded on a 7-point Likert scale with answers ranging from 1 "Strongly Disagree" to 7 "Strongly Agree." Scores will be summed and a total score will range from 2 - 14.
  measure: Clinician Self-Efficacy Scale
  time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.
  description: Assessed by the clinician self-efficacy subscale of the Shared Decision Making (SDM) Questionnaire, which measures clinician self-efficacy to engage older women in shared decision making around mammography screening and is comprised of 5 questions graded on a 7-point Likert scale with answers ranging from 1 "Strongly Disagree/Easy" to 7 "Strongly Agree/Difficult." A total score will range from 5 to 35.
  measure: Clinician Attitudes Scale
  time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.
  description: Assessed by the clinician attitudes Subscale of the Share Decision Making (SDM Questionnaire which is comprised of 4 questions about clinician attitudes towards mammography screening and graded on a 7-point Likert scale with scores ranging from "1 "Unnecessary/Harmful/Unpleasant/Worthless" to 7 "Necessary/Beneficial/Pleasant/Useful." A total score will range from 4 - 28.
  measure: Clinician Perceived Norms Scale
  time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.
  description: Assessed by the clinician perceived norms subscale of the Shared Decision Making (SDM) Questionnaire which is comprised of 4 questions about clinician perceived norms around mammography screening and graded on a 7-point Likert scale with answers ranging from 1 "Strongly Disagree" to 7 "Strongly Agree." A total score will range from 4 - 28.
  arm group label: Patient: Conversation Aid On Mammography Screening
  description: Participants will complete study procedures as follows:
  Pretest questionnaires.
  PCP Appointment with introduction to conversation aid website.
  Post-test questionnaires within two weeks of PCP visit.
  arm group label: Family: Conversation Aid On Mammography Screening
  description: Caretakers/Family members to participants will complete study procedures as follows:
  Pretest questionnaires.
  Attend with participant PCP Appointment with introduction to conversation aid website.
  Post-test questionnaires within two weeks of PCP visit.
  arm group label: Clinician: Conversation Aid On Mammography Screening
  description: Clinicians will complete study procedures as follows:
  Pretest questionnaires.
  Post-test questionnaires.
  intervention type: Behavioral
  intervention name: Mammography Screening Conversation Aid
  description: Web-based, "Decide Together" conversation aid designed to be used by PCP and participant for shared decision making and to provide information on the benefits and harms of mammography screening as well as educational talking points.
  arm group label: Clinician: Conversation Aid On Mammography Screening
  arm group label: Family: Conversation Aid On Mammography Screening
  arm group label: Patient: Conversation Aid On Mammography Screening
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 75 Years
  maximum age: 89 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mara Schonberg, MD, MPH
  role: Principal Investigator
  affiliation: Beth Israel Deaconess Medical Center
  last name: Mara Schonberg, MD, MPH
  phone: 617-754-1414
  email: mschonbe@bidmc.harvard.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Beth Israel Deaconess Medical Center
  investigator full name: Mara Schonberg
  investigator title: Principal Investigator
  mesh term: Breast Neoplasms
  sharing ipd: Yes
  ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Data can be shared no earlier than 1 year following the date of publication
  ipd access criteria: Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu