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Understanding and Addressing Patient and Provider Preferences Around Discussions of Cost of Breast Cancer Care

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cost Discussion
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Cost Discussion

Arm Description

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

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?

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2018
Last Updated
November 18, 2020
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT03780491
Brief Title
Understanding and Addressing Patient and Provider Preferences Around Discussions of Cost of Breast Cancer Care
Official Title
Understanding and Addressing Patient and Provider Preferences Around Discussions of Cost of Breast Cancer Care
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
November 16, 2020 (Actual)
Study Completion Date
November 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
The first 50 patients will have usual care with providers conducting the visit in their typical manner.
Arm Title
Cost Discussion
Arm Type
Experimental
Arm 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(s)
Cost Discussion
Intervention 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?
Primary Outcome Measure Information:
Title
InCharge Financial Distress/Financial Well-being Scale
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.
Time Frame
3-6 months after visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older All patients who present to Huntsman Cancer Hospital/University of Utah for a newly diagnosed breast cancer surgical consultation. Exclusion Criteria: none
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

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Understanding and Addressing Patient and Provider Preferences Around Discussions of Cost of Breast Cancer Care

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