NCT03780491

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

December 17, 2018

Last Update Submit

November 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • InCharge Financial Distress/Financial Well-being Scale

    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.

    3-6 months after visit

Study Arms (2)

Control

NO INTERVENTION

The first 50 patients will have usual care with providers conducting the visit in their typical manner.

Cost Discussion

EXPERIMENTAL

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?

Other: Cost Discussion

Interventions

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?

Cost Discussion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • All patients who present to Huntsman Cancer Hospital/University of Utah for a newly diagnosed breast cancer surgical consultation.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (27)

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    PMID: 26883407BACKGROUND
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    PMID: 27893929BACKGROUND
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    PMID: 23180999BACKGROUND
  • 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.

    PMID: 25273078BACKGROUND
  • 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.

    PMID: 26015459BACKGROUND
  • 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.

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    PMID: 26785714BACKGROUND
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    PMID: 15242471BACKGROUND
  • 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.

    PMID: 19581533BACKGROUND
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    PMID: 24276955BACKGROUND
  • 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.

    PMID: 24839274BACKGROUND
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    PMID: 24857095BACKGROUND
  • 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).

    BACKGROUND
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    PMID: 16051459BACKGROUND
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    PMID: 28692733BACKGROUND
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    PMID: 22618581BACKGROUND
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    PMID: 22492759BACKGROUND
  • 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.

    PMID: 15284259BACKGROUND
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    PMID: 25654742BACKGROUND
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    PMID: 18186862BACKGROUND
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    PMID: 29428232BACKGROUND
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    PMID: 8717600BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Physician

Study Record Dates

First Submitted

December 17, 2018

First Posted

December 19, 2018

Study Start

November 5, 2018

Primary Completion

November 16, 2020

Study Completion

November 16, 2020

Last Updated

November 20, 2020

Record last verified: 2020-11

Locations