<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/NCT03780491</url>
  </required_header>
  <id_info>
    <org_study_id>114421</org_study_id>
    <nct_id>NCT03780491</nct_id>
  </id_info>
  <brief_title>Understanding and Addressing Patient and Provider Preferences Around Discussions of Cost of Breast Cancer Care</brief_title>
  <official_title>Understanding and Addressing Patient and Provider Preferences Around Discussions of Cost of Breast Cancer Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</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 investigators hypothesize that many cancer patients desire discussions of cost as part of&#xD;
      their care, but that preferences for having cost discussions with their physicians vary.&#xD;
      Further, the investigators hypothesize that providers can introduce the topic of cost into&#xD;
      clinical conversations in a balanced way and that this will improve shared decision making&#xD;
      and patient uptake of offers of financial counseling which will lead to improved financial&#xD;
      well-being, patient satisfaction with providers, and satisfaction with treatment decisions.&#xD;
&#xD;
      Aim 1: Further understand patient preferences and attendant associations for cost discussions&#xD;
      through a patient survey of newly diagnosed breast cancer patients.&#xD;
&#xD;
      Aim 2: Study the influence of provider communication about cost on shared decision making,&#xD;
      uptake of financial counseling, financial well-being and satisfaction through an intervention&#xD;
      to encourage discussion of cost by breast cancer surgeons with subsequent referral to&#xD;
      financial counseling.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Newly diagnosed breast cancer patients over the age of 18 will be eligible for participation.&#xD;
      All stages of disease will be included. Eligible participants will be approached in clinic.&#xD;
      Those interested will provide written, informed consent at the time of their clinic visit.&#xD;
      All participants will be asked to complete baseline surveys consisting of the InCharge&#xD;
      Financial Distress/Financial Well Being scale (IFDFW),[24] the Maximizer-Minimizer Scale,[25]&#xD;
      and a three question, 5-point Likert scale survey about desire for cost information (1: How&#xD;
      concerned are participants about the cost of their cancer care? 2: How interested are&#xD;
      participants in discussing cost of care with their doctors? 3: How interested are&#xD;
      participants in meeting with a financial counselor about the costs of their care?)&#xD;
      Demographic information including age, race and ethnicity, marital status, number of&#xD;
      children, current employment status of self and spouse, and education level will be included.&#xD;
      To decrease participant burden and encourage study participation, only the three question&#xD;
      survey will be required to be completed prior to the visit. The other survey components&#xD;
      (IFDFW and Max-Min Scale) can be completed after the visit, but prior to seeing a financial&#xD;
      counselor. Participants will be offered a $10 giftcard of their choice (grocery store,&#xD;
      Starbucks, Amazon, or gas) at each survey timepoint ($20 total) for participation.&#xD;
&#xD;
      For this study, the investigators will use a pre and post design with 100 total participants.&#xD;
      All visits will be audiorecorded, transcribed, and coded for whether cost was discussed in&#xD;
      the control group and whether the intervention was successfully implemented in the&#xD;
      intervention group as well as shared decision making using the observer-OPTION scale. The&#xD;
      first 50 patients will have usual care with providers conducting the visit in their typical&#xD;
      manner.&#xD;
&#xD;
      From our past studies, study team discusses cost in 15% of visits, though these discussion&#xD;
      tend to be very superficial. The second group of 50 patients will be the intervention group&#xD;
      where the providers will have a discussion of cost emphasizing five points: 1) Cancer care is&#xD;
      expensive and it is normal to be concerned about cost. 2) The investigators will recommend&#xD;
      treatments for the participants' cancer based on what the investigators think gives them the&#xD;
      best chance of doing well, not based on the cost of the treatment. 3) Because of how complex&#xD;
      our healthcare system is, it is very hard for their doctors to know what their costs will be,&#xD;
      but the investigators will do our best to give participants some general information. 4) The&#xD;
      investigators have resources available to help participants get more specific information so&#xD;
      that participants can plan appropriately. 5) Do participants have any specific concerns about&#xD;
      cost that participants would like to share with me? The investigators will encourage study&#xD;
      team to have this discussion at the beginning of the consult, but the exact timing will be&#xD;
      according to study team judgment.&#xD;
&#xD;
      After the visit, all patients will complete a patient satisfaction survey and will be offered&#xD;
      a referral to a financial counselor at our institution. Financial counseling will take place&#xD;
      per our usual institutional protocols either in person or over the phone. Our financial&#xD;
      counselors are aware that they may see an increased volume of patients during the study&#xD;
      period and the investigators will provide funding to cover the increased need. Volume will be&#xD;
      tracked during the study period and compared to the non-study period and between the groups.&#xD;
&#xD;
      At the first three to six-month follow-up visit with the surgeon, participants will again&#xD;
      complete the IFDFW, a validated patient satisfaction scale[26], and the Satisfaction with&#xD;
      Decision Scale.[27].&#xD;
&#xD;
      Data will have personal health identifiers removed from the data for the analysis portion of&#xD;
      the study. PHI will not be reused without first seeking IRB approval.&#xD;
&#xD;
      The investigators will enroll 100 patients in two consecutive groups of 50. This gives us 80%&#xD;
      power with a two sided significance level of 0.05 for seeing a 27-30% improvement (0.27-0.3&#xD;
      higher score) in our primary outcome of financial well-being as measured by the IFDFW in the&#xD;
      intervention group at 3-6 months after the initial visit; the average pre-score on the IFDFW&#xD;
      is 5.52 in past studies with improvements of 0.32-1.18 seen in past studies of education&#xD;
      interventions to improve financial well-being.[24] This level of difference may not be&#xD;
      achievable with this small study, but will provide data for powering a larger study.&#xD;
&#xD;
      Maximizer-Minimizer status, uptake of financial counseling, patient satisfaction, decision&#xD;
      satisfaction, and demographic variables will be evaluated for associations with financial&#xD;
      well-being using logistic regression methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2018</start_date>
  <completion_date type="Actual">November 16, 2020</completion_date>
  <primary_completion_date type="Actual">November 16, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>InCharge Financial Distress/Financial Well-being Scale</measure>
    <time_frame>3-6 months after visit</time_frame>
    <description>The InCharge Financial Distress/Financial Well Being scale, an eight-item self-report subjective measure of financial distress/financial well-being. Sores are numeric 1-10. Higher scores indicate higher financial well-being.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The first 50 patients will have usual care with providers conducting the visit in their typical manner.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cost Discussion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The second group of 50 patients will be the intervention group where the providers will have a discussion of cost emphasizing five points: 1) Cancer care is expensive and it is normal to be concerned about cost. 2) We will recommend treatments for your cancer based on what we think gives you the best chance of doing well, not based on the cost of the treatment. 3) Because of how complex our healthcare system is, it is very hard for your doctors to know what your costs will be, but we will do our best to give you some general information. 4) We have resources available to help you get more specific information so that you can plan appropriately. 5) Do you have any specific concerns about cost that you'd like to share with me?</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cost Discussion</intervention_name>
    <description>The second group of 50 patients will be the intervention group where the providers will have a discussion of cost emphasizing five points: 1) Cancer care is expensive and it is normal to be concerned about cost. 2) We will recommend treatments for your cancer based on what we think gives you the best chance of doing well, not based on the cost of the treatment. 3) Because of how complex our healthcare system is, it is very hard for your doctors to know what your costs will be, but we will do our best to give you some general information. 4) We have resources available to help you get more specific information so that you can plan appropriately. 5) Do you have any specific concerns about cost that you'd like to share with me?</description>
    <arm_group_label>Cost Discussion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  All patients who present to Huntsman Cancer Hospital/University of Utah for a newly&#xD;
             diagnosed breast cancer surgical consultation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Altomare I, Irwin B, Zafar SY, Houck K, Maloney B, Greenup R, Peppercorn J. Physician Experience and Attitudes Toward Addressing the Cost of Cancer Care. J Oncol Pract. 2016 Mar;12(3):e281-8, 247-8. doi: 10.1200/JOP.2015.007401. Epub 2016 Feb 16.</citation>
    <PMID>26883407</PMID>
  </reference>
  <reference>
    <citation>Shih YT, Chien CR. A review of cost communication in oncology: Patient attitude, provider acceptance, and outcome assessment. Cancer. 2017 May 15;123(6):928-939. doi: 10.1002/cncr.30423. Epub 2016 Nov 28.</citation>
    <PMID>27893929</PMID>
  </reference>
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    <citation>Farina KL. The economics of cancer care in the United States. Am J Manag Care. 2012 Feb;18(1 Spec No.):SP38-9. No abstract available.</citation>
    <PMID>22468873</PMID>
  </reference>
  <reference>
    <citation>Bullock AJ, Hofstatter EW, Yushak ML, Buss MK. Understanding patients' attitudes toward communication about the cost of cancer care. J Oncol Pract. 2012 Jul;8(4):e50-8. doi: 10.1200/JOP.2011.000418. Epub 2012 Feb 28.</citation>
    <PMID>23180999</PMID>
  </reference>
  <reference>
    <citation>Irwin B, Kimmick G, Altomare I, Marcom PK, Houck K, Zafar SY, Peppercorn J. Patient experience and attitudes toward addressing the cost of breast cancer care. Oncologist. 2014 Nov;19(11):1135-40. doi: 10.1634/theoncologist.2014-0117. Epub 2014 Oct 1.</citation>
    <PMID>25273078</PMID>
  </reference>
  <reference>
    <citation>Kelly RJ, Forde PM, Elnahal SM, Forastiere AA, Rosner GL, Smith TJ. Patients and Physicians Can Discuss Costs of Cancer Treatment in the Clinic. J Oncol Pract. 2015 Jul;11(4):308-12. doi: 10.1200/JOP.2015.003780. Epub 2015 May 26.</citation>
    <PMID>26015459</PMID>
  </reference>
  <reference>
    <citation>Hunter WG, Zafar SY, Hesson A, Davis JK, Kirby C, Barnett JA, Ubel PA. Discussing Health Care Expenses in the Oncology Clinic: Analysis of Cost Conversations in Outpatient Encounters. J Oncol Pract. 2017 Nov;13(11):e944-e956. doi: 10.1200/JOP.2017.022855. Epub 2017 Aug 23.</citation>
    <PMID>28834684</PMID>
  </reference>
  <reference>
    <citation>Hunter WG, Zhang CZ, Hesson A, Davis JK, Kirby C, Williamson LD, Barnett JA, Ubel PA. What Strategies Do Physicians and Patients Discuss to Reduce Out-of-Pocket Costs? Analysis of Cost-Saving Strategies in 1,755 Outpatient Clinic Visits. Med Decis Making. 2016 Oct;36(7):900-10. doi: 10.1177/0272989X15626384. Epub 2016 Jan 19.</citation>
    <PMID>26785714</PMID>
  </reference>
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    <citation>Alexander GC, Casalino LP, Tseng CW, McFadden D, Meltzer DO. Barriers to patient-physician communication about out-of-pocket costs. J Gen Intern Med. 2004 Aug;19(8):856-60. doi: 10.1111/j.1525-1497.2004.30249.x.</citation>
    <PMID>15242471</PMID>
  </reference>
  <reference>
    <citation>Meropol NJ, Schrag D, Smith TJ, Mulvey TM, Langdon RM Jr, Blum D, Ubel PA, Schnipper LE; American Society of Clinical Oncology. American Society of Clinical Oncology guidance statement: the cost of cancer care. J Clin Oncol. 2009 Aug 10;27(23):3868-74. doi: 10.1200/JCO.2009.23.1183. Epub 2009 Jul 6.</citation>
    <PMID>19581533</PMID>
  </reference>
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    <citation>Henrikson NB, Tuzzio L, Loggers ET, Miyoshi J, Buist DS. Patient and oncologist discussions about cancer care costs. Support Care Cancer. 2014 Apr;22(4):961-7. doi: 10.1007/s00520-013-2050-x. Epub 2013 Nov 26.</citation>
    <PMID>24276955</PMID>
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    <citation>Bestvina CM, Zullig LL, Rushing C, Chino F, Samsa GP, Altomare I, Tulsky J, Ubel P, Schrag D, Nicolla J, Abernethy AP, Peppercorn J, Zafar SY. Patient-oncologist cost communication, financial distress, and medication adherence. J Oncol Pract. 2014 May;10(3):162-7. doi: 10.1200/JOP.2014.001406.</citation>
    <PMID>24839274</PMID>
  </reference>
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    <citation>Jagsi R, Sulmasy DP, Moy B. Value of cancer care: ethical considerations for the practicing oncologist. Am Soc Clin Oncol Educ Book. 2014:e146-9. doi: 10.14694/EdBook_AM.2014.34.e146.</citation>
    <PMID>24857095</PMID>
  </reference>
  <reference>
    <citation>Bakshi, N., et al., Shared decision making or physician advocate for a particular treatment option: A spectrum of approaches to decision making about disease modifying therapies in sickle cell disease. Blood, 2016. 128(22).</citation>
  </reference>
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    <citation>Makoul G, Clayman ML. An integrative model of shared decision making in medical encounters. Patient Educ Couns. 2006 Mar;60(3):301-12. doi: 10.1016/j.pec.2005.06.010. Epub 2005 Jul 26.</citation>
    <PMID>16051459</PMID>
  </reference>
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    <citation>Elwyn G, Cochran N, Pignone M. Shared Decision Making-The Importance of Diagnosing Preferences. JAMA Intern Med. 2017 Sep 1;177(9):1239-1240. doi: 10.1001/jamainternmed.2017.1923. No abstract available.</citation>
    <PMID>28692733</PMID>
  </reference>
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    <citation>Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, Cording E, Tomson D, Dodd C, Rollnick S, Edwards A, Barry M. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012 Oct;27(10):1361-7. doi: 10.1007/s11606-012-2077-6. Epub 2012 May 23.</citation>
    <PMID>22618581</PMID>
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    <citation>Cassel CK, Guest JA. Choosing wisely: helping physicians and patients make smart decisions about their care. JAMA. 2012 May 2;307(17):1801-2. doi: 10.1001/jama.2012.476. Epub 2012 Apr 4. No abstract available.</citation>
    <PMID>22492759</PMID>
  </reference>
  <reference>
    <citation>Janz NK, Wren PA, Copeland LA, Lowery JC, Goldfarb SL, Wilkins EG. Patient-physician concordance: preferences, perceptions, and factors influencing the breast cancer surgical decision. J Clin Oncol. 2004 Aug 1;22(15):3091-8. doi: 10.1200/JCO.2004.09.069.</citation>
    <PMID>15284259</PMID>
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    <citation>Jagsi R, Li Y, Morrow M, Janz N, Alderman A, Graff J, Hamilton A, Katz S, Hawley S. Patient-reported Quality of Life and Satisfaction With Cosmetic Outcomes After Breast Conservation and Mastectomy With and Without Reconstruction: Results of a Survey of Breast Cancer Survivors. Ann Surg. 2015 Jun;261(6):1198-206. doi: 10.1097/SLA.0000000000000908.</citation>
    <PMID>25654742</PMID>
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    <citation>Altschuler A, Nekhlyudov L, Rolnick SJ, Greene SM, Elmore JG, West CN, Herrinton LJ, Harris EL, Fletcher SW, Emmons KM, Geiger AM. Positive, negative, and disparate--women's differing long-term psychosocial experiences of bilateral or contralateral prophylactic mastectomy. Breast J. 2008 Jan-Feb;14(1):25-32. doi: 10.1111/j.1524-4741.2007.00521.x.</citation>
    <PMID>18186862</PMID>
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    <citation>Bhutiani N, Mercer MK, Bachman KC, Heidrich SR, Martin RCG 2nd, Scoggins CR, McMasters KM, Ajkay N. Evaluating the Effect of Margin Consensus Guideline Publication on Operative Patterns and Financial Impact of Breast Cancer Operation. J Am Coll Surg. 2018 Jul;227(1):6-11. doi: 10.1016/j.jamcollsurg.2018.01.050. Epub 2018 Feb 9.</citation>
    <PMID>29428232</PMID>
  </reference>
  <reference>
    <citation>Herrick NL, Unkart JT, Reid CM, Li SS, Wallace AM. Process of Care in Breast Reconstruction and the Impact of a Dual-Trained Surgeon. Ann Plast Surg. 2018 May;80(5S Suppl 5):S288-S291. doi: 10.1097/SAP.0000000000001385.</citation>
    <PMID>29489535</PMID>
  </reference>
  <reference>
    <citation>Meeker CR, Wong YN, Egleston BL, Hall MJ, Plimack ER, Martin LP, von Mehren M, Lewis BR, Geynisman DM. Distress and Financial Distress in Adults With Cancer: An Age-Based Analysis. J Natl Compr Canc Netw. 2017 Oct;15(10):1224-1233. doi: 10.6004/jnccn.2017.0161.</citation>
    <PMID>28982748</PMID>
  </reference>
  <reference>
    <citation>Scherer LD, Caverly TJ, Burke J, Zikmund-Fisher BJ, Kullgren JT, Steinley D, McCarthy DM, Roney M, Fagerlin A. Development of the Medical Maximizer-Minimizer Scale. Health Psychol. 2016 Nov;35(11):1276-1287. doi: 10.1037/hea0000417. Epub 2016 Sep 12.</citation>
    <PMID>27617512</PMID>
  </reference>
  <reference>
    <citation>Presson AP, Zhang C, Abtahi AM, Kean J, Hung M, Tyser AR. Psychometric properties of the Press Ganey(R) Outpatient Medical Practice Survey. Health Qual Life Outcomes. 2017 Feb 10;15(1):32. doi: 10.1186/s12955-017-0610-3.</citation>
    <PMID>28183312</PMID>
  </reference>
  <reference>
    <citation>Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, Padonu G, Talarczyk G. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making. 1996 Jan-Mar;16(1):58-64. doi: 10.1177/0272989X9601600114.</citation>
    <PMID>8717600</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>November 18, 2020</last_update_submitted>
  <last_update_submitted_qc>November 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Cindy Matsen, MD</investigator_full_name>
    <investigator_title>Assistant Professor, Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast 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/NCT03780491
org study id: 114421
nct id: NCT03780491
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators hypothesize that many cancer patients desire discussions of cost as part of
      their care, but that preferences for having cost discussions with their physicians vary.
      Further, the investigators hypothesize that providers can introduce the topic of cost into
      clinical conversations in a balanced way and that this will improve shared decision making
      and patient uptake of offers of financial counseling which will lead to improved financial
      well-being, patient satisfaction with providers, and satisfaction with treatment decisions.

      Aim 1: Further understand patient preferences and attendant associations for cost discussions
      through a patient survey of newly diagnosed breast cancer patients.

      Aim 2: Study the influence of provider communication about cost on shared decision making,
      uptake of financial counseling, financial well-being and satisfaction through an intervention
      to encourage discussion of cost by breast cancer surgeons with subsequent referral to
      financial counseling.
Newly diagnosed breast cancer patients over the age of 18 will be eligible for participation.
      All stages of disease will be included. Eligible participants will be approached in clinic.
      Those interested will provide written, informed consent at the time of their clinic visit.
      All participants will be asked to complete baseline surveys consisting of the InCharge
      Financial Distress/Financial Well Being scale (IFDFW),[24] the Maximizer-Minimizer Scale,[25]
      and a three question, 5-point Likert scale survey about desire for cost information (1: How
      concerned are participants about the cost of their cancer care? 2: How interested are
      participants in discussing cost of care with their doctors? 3: How interested are
      participants in meeting with a financial counselor about the costs of their care?)
      Demographic information including age, race and ethnicity, marital status, number of
      children, current employment status of self and spouse, and education level will be included.
      To decrease participant burden and encourage study participation, only the three question
      survey will be required to be completed prior to the visit. The other survey components
      (IFDFW and Max-Min Scale) can be completed after the visit, but prior to seeing a financial
      counselor. Participants will be offered a $10 giftcard of their choice (grocery store,
      Starbucks, Amazon, or gas) at each survey timepoint ($20 total) for participation.

      For this study, the investigators will use a pre and post design with 100 total participants.
      All visits will be audiorecorded, transcribed, and coded for whether cost was discussed in
      the control group and whether the intervention was successfully implemented in the
      intervention group as well as shared decision making using the observer-OPTION scale. The
      first 50 patients will have usual care with providers conducting the visit in their typical
      manner.

      From our past studies, study team discusses cost in 15% of visits, though these discussion
      tend to be very superficial. The second group of 50 patients will be the intervention group
      where the providers will have a discussion of cost emphasizing five points: 1) Cancer care is
      expensive and it is normal to be concerned about cost. 2) The investigators will recommend
      treatments for the participants' cancer based on what the investigators think gives them the
      best chance of doing well, not based on the cost of the treatment. 3) Because of how complex
      our healthcare system is, it is very hard for their doctors to know what their costs will be,
      but the investigators will do our best to give participants some general information. 4) The
      investigators have resources available to help participants get more specific information so
      that participants can plan appropriately. 5) Do participants have any specific concerns about
      cost that participants would like to share with me? The investigators will encourage study
      team to have this discussion at the beginning of the consult, but the exact timing will be
      according to study team judgment.

      After the visit, all patients will complete a patient satisfaction survey and will be offered
      a referral to a financial counselor at our institution. Financial counseling will take place
      per our usual institutional protocols either in person or over the phone. Our financial
      counselors are aware that they may see an increased volume of patients during the study
      period and the investigators will provide funding to cover the increased need. Volume will be
      tracked during the study period and compared to the non-study period and between the groups.

      At the first three to six-month follow-up visit with the surgeon, participants will again
      complete the IFDFW, a validated patient satisfaction scale[26], and the Satisfaction with
      Decision Scale.[27].

      Data will have personal health identifiers removed from the data for the analysis portion of
      the study. PHI will not be reused without first seeking IRB approval.

      The investigators will enroll 100 patients in two consecutive groups of 50. This gives us 80%
      power with a two sided significance level of 0.05 for seeing a 27-30% improvement (0.27-0.3
      higher score) in our primary outcome of financial well-being as measured by the IFDFW in the
      intervention group at 3-6 months after the initial visit; the average pre-score on the IFDFW
      is 5.52 in past studies with improvements of 0.32-1.18 seen in past studies of education
      interventions to improve financial well-being.[24] This level of difference may not be
      achievable with this small study, but will provide data for powering a larger study.

      Maximizer-Minimizer status, uptake of financial counseling, patient satisfaction, decision
      satisfaction, and demographic variables will be evaluated for associations with financial
      well-being using logistic regression methods.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: InCharge Financial Distress/Financial Well-being Scale
time frame: 3-6 months after visit
description: The InCharge Financial Distress/Financial Well Being scale, an eight-item self-report subjective measure of financial distress/financial well-being. Sores are numeric 1-10. Higher scores indicate higher financial well-being.
arm group label: Control
arm group type: No Intervention
description: The first 50 patients will have usual care with providers conducting the visit in their typical manner.
arm group label: Cost Discussion
arm group type: Experimental
description: The second group of 50 patients will be the intervention group where the providers will have a discussion of cost emphasizing five points: 1) Cancer care is expensive and it is normal to be concerned about cost. 2) We will recommend treatments for your cancer based on what we think gives you the best chance of doing well, not based on the cost of the treatment. 3) Because of how complex our healthcare system is, it is very hard for your doctors to know what your costs will be, but we will do our best to give you some general information. 4) We have resources available to help you get more specific information so that you can plan appropriately. 5) Do you have any specific concerns about cost that you'd like to share with me?
intervention type: Other
intervention name: Cost Discussion
description: The second group of 50 patients will be the intervention group where the providers will have a discussion of cost emphasizing five points: 1) Cancer care is expensive and it is normal to be concerned about cost. 2) We will recommend treatments for your cancer based on what we think gives you the best chance of doing well, not based on the cost of the treatment. 3) Because of how complex our healthcare system is, it is very hard for your doctors to know what your costs will be, but we will do our best to give you some general information. 4) We have resources available to help you get more specific information so that you can plan appropriately. 5) Do you have any specific concerns about cost that you'd like to share with me?
arm group label: Cost Discussion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
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responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Cindy Matsen, MD
investigator title: Assistant Professor, Physician
mesh term: Breast Neoplasms