Breast CancerNCT02831439
A Statewide Intervention to Reduce Use of Unproven or Ineffective Breast Cancer Care
A study testing Basic public reporting and Enhanced intervention in people with Breast Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The goal of this project is to examine the effectiveness and potential cost savings of two organizational interventions aimed at reducing the use of ineffective or unproven care among women with incident breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Basic public reporting and Enhanced intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400,415 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2019
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Health care providers: Health care providers (regardless of age, gender or race/ethnicity) in participating WCHQ practices who will provide breast cancer care to about 9,000 women who had an incident breast cancer surgery between 2014-2017.
- Patients: Medicare and Marketscan women who had an incident breast cancer surgery between 2014-2017. No exclusions will be made by age or race/ethnicity. The focus on women is dictated by the very low prevalence of breast cancer among men.
- Identification of incident breast cancer surgery in these datasets will be done using a validated algorithm developed by Nattinger et al.
Who cannot join
- Male patients are excluded from this analysis due to the low prevalence of breast cancer among males.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
The goal of this project is to examine the effectiveness and potential cost savings of two organizational interventions aimed at reducing the use of ineffective or unproven care among women with incident breast cancer.
Read the detailed description
Challenged by public opinion, peers and the Congressional Budget Office, a number of specialty societies have recently begun to develop "Top Five" lists of relatively expensive procedures that do not provide meaningful benefit to at least some categories of patients for whom they are commonly ordered. The Choosing Wisely® campaign is the most visible example. The extent to which the development of these lists has influenced the behavior of physicians or patients, however, remains unknown.
In this study, investigators partner with the Wisconsin Collaborative for Healthcare Quality (WCHQ), a statewide consortium of hospitals, medical practices and health systems, to examine the effectiveness of two organizational interventions in reducing unproven or ineffective breast cancer care. Two interventions will be tested: (a) A "basic" public reporting intervention which summarizes on a public website practice-level statistics regarding use of targeted ineffective or unproven interventions for breast cancer and (ii) an "enhanced" intervention, augmenting public reporting with a smart phone-based application (App) that gives providers just-in-time information, decision-making tools, and personalized patient education materials that support reductions in the use of breast cancer interventions targeted based upon Choosing Wisely® or national oncology society guidelines. Specifically, the aims are: (1) To examine whether basic public reporting reduces use of targeted breast cancer practices among a contemporary cohort of patients with incident breast cancer in the intervention state relative to usual care in comparison states, using Marketscan and Medicare claims data while adjusting for possible confounders and temporal trends; (2) To examine the effectiveness of the enhanced intervention relative to the basic intervention; and (3) To simulate cost savings forthcoming from nationwide implementation of both interventions (relative to each other and to usual care) and to describe the implications of these findings for reimbursement policy and program initiatives.
The results will provide rigorous evidence regarding the effectiveness of a unique all-payer, all-age public reporting system for influencing provider behavior that may be easily exportable to other states. Findings will be further relevant to the ACO environment, which is expected to provide financial disincentives for providing ineffective or unproven care.
- Conditions
- Breast Cancer
- Being tested
- Basic public reporting, Enhanced intervention, Control group - observational
- Keywords
- Choosing Wisely, Breast cancer, Controlled trial, High-value health care, Health services research
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic public reportingBehavioural
The basic intervention will comprise public reporting through the WCHQ website. Individual-level, claims data submitted for billing to third party payers by participating healthsystems will be used to (i) identify cohorts of women with incident breast cancer at the practice-level and (ii) construct the metrics for public reporting and individual benchmarking information. These data are consistent with Medicare and Marketscan claims in both format and content thereby ensuring seamless application of the validated algorithm as well as construction of outcome variables as proposed in Aims 1 and 2 of the study.
Enhanced interventionBehavioural
The enhanced intervention adds an app comprising a decision tool, patient education and communication information that will be delivering concise, readily accessible information about the main components of the intervention. Specifically, physicians in participating practices will be provided a smartphone-based, point-of-care application that will include i) a list of the unproven/ineffective interventions with statements about a) scientifically proven appropriate use; b) proven or suspected downsides to inappropriate use; ii) clinical calculators that allow physician to input individual patients' clinical/tumor characteristics for each test; iii) practice-specific summary of publicly reported results; and iv) printable patient information adapted from the ASCO Choosing Wisely website.
Control group - observationalBehavioural
Also called Control group
Comparison states will be used to evaluate the interventions in light of possible secular trends in the region and the nation. The design strategy will enable estimates of the effectiveness of the basic intervention (Aim 1) by comparing (i) the pre-intervention rates to post-intervention rates as well as by comparing (ii) changes between the pre- and post-intervention periods for the "treatment" state (WI) relative to comparison states, neighboring states and others. A similar approach will be used in Part II to provide estimates of the enhanced intervention's impact relative to the basic intervention and contemporary usual care provided in control states, thereby enabling the cost-savings analyses proposed as part of Aim 3.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participating health systems in Wisconsin. Interventions include: Basic public reporting and the enhanced intervention (app) Receives: Behavioral: Basic public reporting; Behavioral: Enhanced intervention |
| Control | Other | Health systems in comparison states. Control includes: Cost savings comparison Receives: Behavioral: Control group - observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Women who received Intensity Modulated Radiation Therapy (IMRT) after Breast Conserving Surgery (defined as CPT 77418, 77385, 77386).
The American Society for Radiation Oncology's Choosing Wisely® list recommends against performing IMRT, a 3-dimensional technique that has not been demonstrated to provide a significant clinical advantage over the standard 2-dimensional technique for whole breast radiation therapy after breast conserving surgery.
Measured: Date of surgery plus 180 days
Percent of Women had a CPM
(CPT 19303 OR 19304 w/mod 50; OR ICD-9 85.35 OR 85.36 OR 85.42; OR two claims within 1 day with ICD-9 85.33 OR 85.34 OR 85.41 OR 85.43 OR 85.45 OR 85.47, EXCLUDING two 85.45 OR two 85.47 OR (85.45 AND 85.47); OR conditions (a) AND (b) The National Comprehensive Cancer Network and the Society of Surgical Oncology indicate that there are no proven survival benefits to performing a Contralateral Prophylactic Mastectomy (CPM: removal of the unaffected breast). Despite the lack of survival benefit, this procedure may be considered appropriate in cases where there is high risk of cancer occurring in the unaffected breast and/or radiographic surveillance of the unaffected breast would be difficult. Such factors may include genetic predisposition to breast cancer, strong family history of breast cancer, high-risk histology (atypical hyperplasia or lobular carcinoma in situ), prior radiation treatment to the chest, and dense breast tissue.
Measured: Date of ipsilateral mastectomy surgery plus 1 day. Excluded from denominator if had any genetic predisposition counseling, testing, or family history codes within 180-days prior to surgery.
Percentage of Women who received Tumor Biomarker Blood Testing for Surveillance (defined as CPT 82378 (CEA); 86300 (CA 15-3)
The American Society of Clinical Oncology's Choosing Wisely® list recommends against performing tumor biomarker blood tests (CA 15-3, CA 27.29, CEA) for breast cancer surveillance in asymptomatic women who have been treated with curative intent. Tumor markers may be indicated if there is concern for disease recurrence (development of symptoms or abnormal imaging findings).
Measured: From 181 days post-date of surgery up to 4 years
Percentage of Women who received PET Scan or PET-CT Scan for Surveillance (defined as CPT 78811-78816; HCPCS G0235, G0252, S8085)
The American Society of Clinical Oncology's Choosing Wisely® list recommends against performing a positron emission tomography (PET) scan or a positron emission tomography-computed tomography (PET-CT) scan for routine breast cancer surveillance in asymptomatic patients who have been treated with curative intent, citing their unproven effectiveness in improving survival. PET/PET-CT scan may be indicated if there is concern for disease recurrence (development of symptoms or lab abnormalities) or to follow-up a prior abnormal PET/PET-CT scan finding.
Measured: From 181 days post-date of surgery up to 4 years
Percentage of Women who received CT Scan for Surveillance (defined as CPT 71250, 71260, 71270, 72192-72194, 74150, 74160, 74170, 74176-74178)
The American Society of Clinical Oncology's Choosing Wisely® list recommends against performing a computerized tomography (CT or CAT) scan of the chest, abdomen or pelvis for routine breast cancer surveillance in asymptomatic patients who have been treated with curative intent, citing their unproven effectiveness in improving survival. CT scan may be indicated if there is concern for disease recurrence (development of symptoms or lab abnormalities) or to follow-up a prior abnormal CT scan finding.
Measured: From 181 days post-date of surgery up to 4 years
Percentage of Women who received Bone Scan for Surveillance (defined as CPT 78306)
The American Society of Clinical Oncology's Choosing Wisely® list recommends against performing a bone scan for routine breast cancer surveillance in asymptomatic patients who have been treated with curative intent, citing their unproven effectiveness in improving survival. Bone scan may be indicated if there is concern for disease recurrence (development of symptoms or lab abnormalities) or to follow-up a prior abnormal bone scan finding.
Measured: From 181 days post-date of surgery up to 4 years
Percentage of Women who received Breast MRI for Surveillance (defined as CPT 77058, 77059; HCPCS C8903-8908)
The American Society of Clinical Oncology, the American Cancer Society and the American Society of Breast Surgeons recommend against performing a breast magnetic resonance imaging (MRI) for routine breast cancer surveillance in asymptomatic patients who have been treated with curative intent, citing their unproven effectiveness in improving survival. Breast MRI is currently recommended only for women at very high risk for developing another breast cancer, such as BRCA1/2 mutation carriers, history of chest wall radiation therapy and women with a 20% or greater lifetime risk of developing another breast cancer. Breast MRI may be considered in patients with very dense breasts or a strong family history of breast cancer. Breast MRI may also be indicated for follow-up of a prior abnormal breast MRI finding.
Measured: From 181 days post-date of surgery up to 4 years
Percentage of Women who received Follow-Up Mammograms More Frequently than Annually for Patients Treated with Breast Conserving Surgery & Radiotherapy (defined as CPT 77051, 77052, 77055-77057, 77061-77063 HCPCS G0202, G0204, G0206, G0279)
The American Society for Radiation Oncology's Choosing Wisely® list recommends against performing routine follow-up mammograms more frequently than annually in asymptomatic patients treated with breast conserving surgery and radiotherapy, citing no clear advantage to shorter interval imaging.
Measured: From 365 days post-surgery to 730 days post-surgery
Secondary outcomes (1)
Secondary costs associated with breast cancer care
Direct medical care costs for the initial diagnosis and evaluation, initial treatment as well as any neoadjuvant, adjuvant and surveillance care received during the first 24 months post-diagnosis will be calculated using Marketscan and Medicare claims data.
Measured: From date of initial diagnosis up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startSep 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)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 Medical College of WisconsinThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400,415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Wisconsin Collaborative for Healthcare Quality, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ann Nattinger, Medical College of Wisconsin
- Investigators
- Ann Nattinger, MD, MPH, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831439
- Sponsor's protocol ID
- PRO00022912
- Other IDs
- R01CA190016
- Status last verified
- Jan 2020
- First submitted
- 21 Jun 2016
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yen TW, Laud PW, Sparapani RA, Nattinger AB. Surgeon specialization and use of sentinel lymph node biopsy for breast cancer. JAMA Surg. 2014 Feb;149(2):185-92. doi: 10.1001/jamasurg.2013.4350.
PubMed 24369337Grimshaw JM, Thomson MA. What have new efforts to change professional practice achieved? Cochrane Effective Practice and Organization of Care Group. J R Soc Med. 1998;91 Suppl 35(Suppl 35):20-5. doi: 10.1177/014107689809135S06. No abstract available.
PubMed 9797746Davis DA, Taylor-Vaisey A. Translating guidelines into practice. A systematic review of theoretic concepts, practical experience and research evidence in the adoption of clinical practice guidelines. CMAJ. 1997 Aug 15;157(4):408-16.
PubMed 9275952Bero LA, Grilli R, Grimshaw JM, Harvey E, Oxman AD, Thomson MA. Closing the gap between research and practice: an overview of systematic reviews of interventions to promote the implementation of research findings. The Cochrane Effective Practice and Organization of Care Review Group. BMJ. 1998 Aug 15;317(7156):465-8. doi: 10.1136/bmj.317.7156.465. No abstract available.
PubMed 9703533Grimshaw JM, Shirran L, Thomas R, Mowatt G, Fraser C, Bero L, Grilli R, Harvey E, Oxman A, O'Brien MA. Changing provider behavior: an overview of systematic reviews of interventions. Med Care. 2001 Aug;39(8 Suppl 2):II2-45.
PubMed 11583120Balas EA, Austin SM, Mitchell JA, Ewigman BG, Bopp KD, Brown GD. The clinical value of computerized information services. A review of 98 randomized clinical trials. Arch Fam Med. 1996 May;5(5):271-8. doi: 10.1001/archfami.5.5.271.
PubMed 8620266Chueh H, Barnett GO. "Just-in-time" clinical information. Acad Med. 1997 Jun;72(6):512-7. doi: 10.1097/00001888-199706000-00016.
PubMed 9200584Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, Rubin HR. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999 Oct 20;282(15):1458-65. doi: 10.1001/jama.282.15.1458.
PubMed 10535437Davis DA, Thomson MA, Oxman AD, Haynes RB. Changing physician performance. A systematic review of the effect of continuing medical education strategies. JAMA. 1995 Sep 6;274(9):700-5. doi: 10.1001/jama.274.9.700.
PubMed 7650822Fung CH, Lim YW, Mattke S, Damberg C, Shekelle PG. Systematic review: the evidence that publishing patient care performance data improves quality of care. Ann Intern Med. 2008 Jan 15;148(2):111-23. doi: 10.7326/0003-4819-148-2-200801150-00006.
PubMed 18195336Ketelaar NA, Faber MJ, Flottorp S, Rygh LH, Deane KH, Eccles MP. Public release of performance data in changing the behaviour of healthcare consumers, professionals or organisations. Cochrane Database Syst Rev. 2011 Nov 9;(11):CD004538. doi: 10.1002/14651858.CD004538.pub2.
PubMed 22071813Berwick DM, James B, Coye MJ. Connections between quality measurement and improvement. Med Care. 2003 Jan;41(1 Suppl):I30-8. doi: 10.1097/00005650-200301001-00004.
PubMed 12544814Smith MA, Wright A, Queram C, Lamb GC. Public reporting helped drive quality improvement in outpatient diabetes care among Wisconsin physician groups. Health Aff (Millwood). 2012 Mar;31(3):570-7. doi: 10.1377/hlthaff.2011.0853.
PubMed 22392668Lamb GC, Smith MA, Weeks WB, Queram C. Publicly reported quality-of-care measures influenced Wisconsin physician groups to improve performance. Health Aff (Millwood). 2013 Mar;32(3):536-43. doi: 10.1377/hlthaff.2012.1275.
PubMed 23459733Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst. 2011 Jan 19;103(2):117-28. doi: 10.1093/jnci/djq495. Epub 2011 Jan 12.
PubMed 21228314
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Statewide Intervention to Reduce Use of Unproven or Ineffective Breast Cancer Care
- ClinicalTrials.gov ID
- NCT02831439
- Acronym / sponsor ID
- PRO00022912
- Conditions
- Breast Cancer
- Keywords
- Choosing Wisely, Breast cancer, Controlled trial, High-value health care, Health services research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400,415 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Wisconsin Collaborative for Healthcare Quality, National Cancer Institute (NCI)
- Study start
- Sep 2014
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 13 Jul 2016 (estimated)
- 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 goal of this project is to examine the effectiveness and potential cost savings of two organizational interventions aimed at reducing the use of ineffective or unproven care among women with incident breast cancer.
Detailed description
Challenged by public opinion, peers and the Congressional Budget Office, a number of specialty societies have recently begun to develop "Top Five" lists of relatively expensive procedures that do not provide meaningful benefit to at least some categories of patients for whom they are commonly ordered. The Choosing Wisely® campaign is the most visible example. The extent to which the development of these lists has influenced the behavior of physicians or patients, however, remains unknown.
In this study, investigators partner with the Wisconsin Collaborative for Healthcare Quality (WCHQ), a statewide consortium of hospitals, medical practices and health systems, to examine the effectiveness of two organizational interventions in reducing unproven or ineffective breast cancer care. Two interventions will be tested: (a) A "basic" public reporting intervention which summarizes on a public website practice-level statistics regarding use of targeted ineffective or unproven interventions for breast cancer and (ii) an "enhanced" intervention, augmenting public reporting with a smart phone-based application (App) that gives providers just-in-time information, decision-making tools, and personalized patient education materials that support reductions in the use of breast cancer interventions targeted based upon Choosing Wisely® or national oncology society guidelines. Specifically, the aims are: (1) To examine whether basic public reporting reduces use of targeted breast cancer practices among a contemporary cohort of patients with incident breast cancer in the intervention state relative to usual care in comparison states, using Marketscan and Medicare claims data while adjusting for possible confounders and temporal trends; (2) To examine the effectiveness of the enhanced intervention relative to the basic intervention; and (3) To simulate cost savings forthcoming from nationwide implementation of both interventions (relative to each other and to usual care) and to describe the implications of these findings for reimbursement policy and program initiatives.
The results will provide rigorous evidence regarding the effectiveness of a unique all-payer, all-age public reporting system for influencing provider behavior that may be easily exportable to other states. Findings will be further relevant to the ACO environment, which is expected to provide financial disincentives for providing ineffective or unproven care.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Basic public reporting, Behavioral: Enhanced interventionParticipating health systems in Wisconsin. Interventions include: Basic public reporting and the enhanced intervention (app) |
| Control | Other | Behavioral: Control group - observationalHealth systems in comparison states. Control includes: Cost savings comparison |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Health care providers: Health care providers (regardless of age, gender or race/ethnicity) in participating WCHQ practices who will provide breast cancer care to about 9,000 women who had an incident breast cancer surgery between 2014-2017.
- Patients: Medicare and Marketscan women who had an incident breast cancer surgery between 2014-2017. No exclusions will be made by age or race/ethnicity. The focus on women is dictated by the very low prevalence of breast cancer among men.
- Identification of incident breast cancer surgery in these datasets will be done using a validated algorithm developed by Nattinger et al.
Key exclusion criteria (1 listed)
- Male patients are excluded from this analysis due to the low prevalence of breast cancer among males.
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 |
|---|---|---|
| Basic public reportingThe basic intervention will comprise public reporting through the WCHQ website. Individual-level, claims data submitted for billing to third party payers by participating healthsystems will be used to (i) identify cohorts of women with incident breast cancer at the practice-level and (ii) construct the metrics for public reporting and individual benchmarking information. These data are consistent with Medicare and Marketscan claims in both format and content thereby ensuring seamless application of the validated algorithm as well as construction of outcome variables as proposed in Aims 1 and 2 of the study. | Behavioural | Intervention |
| Enhanced interventionThe enhanced intervention adds an app comprising a decision tool, patient education and communication information that will be delivering concise, readily accessible information about the main components of the intervention. Specifically, physicians in participating practices will be provided a smartphone-based, point-of-care application that will include i) a list of the unproven/ineffective interventions with statements about a) scientifically proven appropriate use; b) proven or suspected downsides to inappropriate use; ii) clinical calculators that allow physician to input individual patients' clinical/tumor characteristics for each test; iii) practice-specific summary of publicly reported results; and iv) printable patient information adapted from the ASCO Choosing Wisely website. | Behavioural | Intervention |
| Control group - observationalAlso: Control groupComparison states will be used to evaluate the interventions in light of possible secular trends in the region and the nation. The design strategy will enable estimates of the effectiveness of the basic intervention (Aim 1) by comparing (i) the pre-intervention rates to post-intervention rates as well as by comparing (ii) changes between the pre- and post-intervention periods for the "treatment" state (WI) relative to comparison states, neighboring states and others. A similar approach will be used in Part II to provide estimates of the enhanced intervention's impact relative to the basic intervention and contemporary usual care provided in control states, thereby enabling the cost-savings analyses proposed as part of Aim 3. | Behavioural | Control |
Primary outcome
Percentage of Women who received Intensity Modulated Radiation Therapy (IMRT) after Breast Conserving Surgery (defined as CPT 77418, 77385, 77386).
Time frame: Date of surgery plus 180 days
The American Society for Radiation Oncology's Choosing Wisely® list recommends against performing IMRT, a 3-dimensional technique that has not been demonstrated to provide a significant clinical advantage over the standard 2-dimensional technique for whole breast radiation therapy after breast conserving surgery.
Percent of Women had a CPM
Time frame: Date of ipsilateral mastectomy surgery plus 1 day. Excluded from denominator if had any genetic predisposition counseling, testing, or family history codes within 180-days prior to surgery.
(CPT 19303 OR 19304 w/mod 50; OR ICD-9 85.35 OR 85.36 OR 85.42; OR two claims within 1 day with ICD-9 85.33 OR 85.34 OR 85.41 OR 85.43 OR 85.45 OR 85.47, EXCLUDING two 85.45 OR two 85.47 OR (85.45 AND 85.47); OR conditions (a) AND (b) The National Comprehensive Cancer Network and the Society of Surgical Oncology indicate that there are no proven survival benefits to performing a Contralateral Prophylactic Mastectomy (CPM: removal of the unaffected breast). Despite the lack of survival benefit, this procedure may be considered appropriate in cases where there is high risk of cancer occurring in the unaffected breast and/or radiographic surveillance of the unaffected breast would be difficult. Such factors may include genetic predisposition to breast cancer, strong family history of breast cancer, high-risk histology (atypical hyperplasia or lobular carcinoma in situ), prior radiation treatment to the chest, and dense breast tissue.
Percentage of Women who received Tumor Biomarker Blood Testing for Surveillance (defined as CPT 82378 (CEA); 86300 (CA 15-3)
Time frame: From 181 days post-date of surgery up to 4 years
The American Society of Clinical Oncology's Choosing Wisely® list recommends against performing tumor biomarker blood tests (CA 15-3, CA 27.29, CEA) for breast cancer surveillance in asymptomatic women who have been treated with curative intent. Tumor markers may be indicated if there is concern for disease recurrence (development of symptoms or abnormal imaging findings).
Percentage of Women who received PET Scan or PET-CT Scan for Surveillance (defined as CPT 78811-78816; HCPCS G0235, G0252, S8085)
Time frame: From 181 days post-date of surgery up to 4 years
The American Society of Clinical Oncology's Choosing Wisely® list recommends against performing a positron emission tomography (PET) scan or a positron emission tomography-computed tomography (PET-CT) scan for routine breast cancer surveillance in asymptomatic patients who have been treated with curative intent, citing their unproven effectiveness in improving survival. PET/PET-CT scan may be indicated if there is concern for disease recurrence (development of symptoms or lab abnormalities) or to follow-up a prior abnormal PET/PET-CT scan finding.
Percentage of Women who received CT Scan for Surveillance (defined as CPT 71250, 71260, 71270, 72192-72194, 74150, 74160, 74170, 74176-74178)
Time frame: From 181 days post-date of surgery up to 4 years
The American Society of Clinical Oncology's Choosing Wisely® list recommends against performing a computerized tomography (CT or CAT) scan of the chest, abdomen or pelvis for routine breast cancer surveillance in asymptomatic patients who have been treated with curative intent, citing their unproven effectiveness in improving survival. CT scan may be indicated if there is concern for disease recurrence (development of symptoms or lab abnormalities) or to follow-up a prior abnormal CT scan finding.
Percentage of Women who received Bone Scan for Surveillance (defined as CPT 78306)
Time frame: From 181 days post-date of surgery up to 4 years
The American Society of Clinical Oncology's Choosing Wisely® list recommends against performing a bone scan for routine breast cancer surveillance in asymptomatic patients who have been treated with curative intent, citing their unproven effectiveness in improving survival. Bone scan may be indicated if there is concern for disease recurrence (development of symptoms or lab abnormalities) or to follow-up a prior abnormal bone scan finding.
Percentage of Women who received Breast MRI for Surveillance (defined as CPT 77058, 77059; HCPCS C8903-8908)
Time frame: From 181 days post-date of surgery up to 4 years
The American Society of Clinical Oncology, the American Cancer Society and the American Society of Breast Surgeons recommend against performing a breast magnetic resonance imaging (MRI) for routine breast cancer surveillance in asymptomatic patients who have been treated with curative intent, citing their unproven effectiveness in improving survival. Breast MRI is currently recommended only for women at very high risk for developing another breast cancer, such as BRCA1/2 mutation carriers, history of chest wall radiation therapy and women with a 20% or greater lifetime risk of developing another breast cancer. Breast MRI may be considered in patients with very dense breasts or a strong family history of breast cancer. Breast MRI may also be indicated for follow-up of a prior abnormal breast MRI finding.
Percentage of Women who received Follow-Up Mammograms More Frequently than Annually for Patients Treated with Breast Conserving Surgery & Radiotherapy (defined as CPT 77051, 77052, 77055-77057, 77061-77063 HCPCS G0202, G0204, G0206, G0279)
Time frame: From 365 days post-surgery to 730 days post-surgery
The American Society for Radiation Oncology's Choosing Wisely® list recommends against performing routine follow-up mammograms more frequently than annually in asymptomatic patients treated with breast conserving surgery and radiotherapy, citing no clear advantage to shorter interval imaging.
1 secondary outcome
Secondary costs associated with breast cancer care
Time frame: From date of initial diagnosis up to 24 months
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 22 Jan 2020.
- Background: PubMed 24369337Yen TW, Laud PW, Sparapani RA, Nattinger AB. Surgeon specialization and use of sentinel lymph node biopsy for breast cancer. JAMA Surg. 2014 Feb;149(2):185-92. doi: 10.1001/jamasurg.2013.4350.
- Background: PubMed 9797746Grimshaw JM, Thomson MA. What have new efforts to change professional practice achieved? Cochrane Effective Practice and Organization of Care Group. J R Soc Med. 1998;91 Suppl 35(Suppl 35):20-5. doi: 10.1177/014107689809135S06. No abstract available.
- Background: PubMed 9275952Davis DA, Taylor-Vaisey A. Translating guidelines into practice. A systematic review of theoretic concepts, practical experience and research evidence in the adoption of clinical practice guidelines. CMAJ. 1997 Aug 15;157(4):408-16.
- Background: PubMed 9703533Bero LA, Grilli R, Grimshaw JM, Harvey E, Oxman AD, Thomson MA. Closing the gap between research and practice: an overview of systematic reviews of interventions to promote the implementation of research findings. The Cochrane Effective Practice and Organization of Care Review Group. BMJ. 1998 Aug 15;317(7156):465-8. doi: 10.1136/bmj.317.7156.465. No abstract available.
- Background: PubMed 11583120Grimshaw JM, Shirran L, Thomas R, Mowatt G, Fraser C, Bero L, Grilli R, Harvey E, Oxman A, O'Brien MA. Changing provider behavior: an overview of systematic reviews of interventions. Med Care. 2001 Aug;39(8 Suppl 2):II2-45.
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- Choosing WiselyLink provided by the sponsor.
- American Society of Breast Surgeons. Official statements.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ann Nattinger, MD, MPH principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic public reporting and Enhanced intervention in people with Breast Cancer, run by Medical College of Wisconsin 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 3 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 22 Jan 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?
Percentage of Women who received Intensity Modulated Radiation Therapy (IMRT) after Breast Conserving Surgery (defined as CPT 77418, 77385, 77386). (time frame: Date of surgery plus 180 days). The study lists 8 primary outcomes in all. 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 NCT02831439, which also lists 32 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 22 Jan 2020.