Breast CancerNCT03780491
Understanding and Addressing Patient and Provider Preferences Around Discussions of Cost of Breast Cancer Care
A study testing Cost Discussion in people with Breast Cancer, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cost Discussion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2018to 16 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- All patients who present to Huntsman Cancer Hospital/University of Utah for a newly diagnosed breast cancer surgical consultation.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Cost Discussion
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cost DiscussionOther
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?
| Study group | Role | What they receive |
|---|---|---|
| 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? Receives: Other: Cost Discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-6 months after visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start5 Nov 2018
- Primary completion16 Nov 2020
- Study completion16 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cindy Matsen, MD, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780491
- Sponsor's protocol ID
- 114421
- Status last verified
- Nov 2020
- First submitted
- 17 Dec 2018
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26883407Shih 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.
PubMed 27893929Farina 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.
PubMed 22468873Bullock 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.
PubMed 23180999Irwin 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.
PubMed 25273078Kelly 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.
PubMed 26015459Hunter 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.
PubMed 28834684Hunter 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.
PubMed 26785714Alexander 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.
PubMed 15242471Meropol 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.
PubMed 19581533Henrikson 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.
PubMed 24276955Bestvina 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.
PubMed 24839274Jagsi 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.
PubMed 24857095Bakshi, 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).
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.
PubMed 16051459
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Addressing Patient and Provider Preferences Around Discussions of Cost of Breast Cancer Care
- ClinicalTrials.gov ID
- NCT03780491
- Acronym / sponsor ID
- 114421
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The first 50 patients will have usual care with providers conducting the visit in their typical manner. |
| Cost Discussion | Experimental | Other: Cost DiscussionThe 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? |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older
- All patients who present to Huntsman Cancer Hospital/University of Utah for a newly diagnosed breast cancer surgical consultation.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cost DiscussionThe 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 |
Primary outcome
InCharge Financial Distress/Financial Well-being Scale
Time frame: 3-6 months after visit
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Background: PubMed 26883407Altomare 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.
- Background: PubMed 27893929Shih 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.
- Background: PubMed 22468873Farina 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.
- Background: PubMed 23180999Bullock 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.
- Background: PubMed 25273078Irwin 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.
- Background: PubMed 26015459Kelly 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.
- Background: PubMed 28834684Hunter 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.
- Background: PubMed 26785714Hunter 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.
- Background: PubMed 15242471Alexander 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.
- Background: PubMed 19581533Meropol 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.
- Background: PubMed 24276955Henrikson 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.
- Background: PubMed 24839274Bestvina 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cost Discussion in people with Breast Cancer, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
InCharge Financial Distress/Financial Well-being Scale (time frame: 3-6 months after visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03780491, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.