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  • 1
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2018
    In:  Journal of Clinical Oncology Vol. 36, No. 15_suppl ( 2018-05-20), p. TPS599-TPS599
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 15_suppl ( 2018-05-20), p. TPS599-TPS599
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
    detail.hit.zdb_id: 2005181-5
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  • 2
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. e12576-e12576
    Abstract: e12576 Background: Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET), is a phase III multicenter prospective randomized clinical trial comparing the risks/benefits of active monitoring (AM) versus surgery for women with low-risk DCIS. Funded by the Patient-Centered Outcomes Research Institute, accrual opened 06/30/17 and closed 01/13/23 with 995 women enrolled. Biospecimens (blood/tissue) and breast images were collected at specified timepoints (funded by the Breast Cancer Research Foundation) and stored in central tissue/image repositories. To date, more than 90% of requested samples/images have been submitted. Methods: In 2017, the COMET Translational Working Group (TWG) was formed to facilitate the collection, submission, storage, and subsequent analysis of biospecimens/images. The TWG, consisting of clinicians, pathologists, radiologists, researchers, and patient advocates (PAs), discuss topics such as categorization of biospecimens into discovery/validation sets; development of a pathology workflow/sample tracking process; and potential areas of future research that may improve DCIS diagnostics, prognostics, and care management. Results: The TWG consists of multiple partner institutions, and team members have complementary areas of expertise/experience. While competing views may exist, consensus has been achieved in relation to major issues such as authorship, biospecimen ownership, intellectual property and criteria relevant to patient needs, through targeted discussion at monthly meetings. Logistical barriers, including data sharing and the technicalities of biospecimen release, have also been resolved through this process. The TWG has played an integral role in resolving recruitment challenges. In 2019, guidance from the TWG related to standardizing pathology eligibility criteria resulted in evidence-based protocol amendments that subsequently increased accrual. A retrospective review of biospecimens was performed to determine adequacy for ensuing correlative molecular and spatial profiling studies. PAs are integral to the TWG, assisting with logistical issues (resource requests); identifying study topics relevant to patients; providing guidance on existing (commercial) predictive/prognostic tests; promoting effective stewardship of a finite resource (tissue samples); and ensuring that the overall focus of the TWG remains firmly on advancing clinical utility. Conclusions: The COMET TWG serves the important role of overseeing biospecimen/image collection including its use and sharing. This facilitates development of research and technology that can impact the decision for surgery vs AM in women with low-risk DCIS, and ensure the translation of research findings into everyday clinical practice. Subsequent correlative science studies identified by the TWG stand to improve future DCIS pathology diagnostics, prognostics and care management.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 3
    In: BMJ Open, BMJ, Vol. 9, No. 3 ( 2019-03), p. e026797-
    Abstract: Ductal carcinoma in situ (DCIS) is a non-invasive non-obligate precursor of invasive breast cancer. With guideline concordant care (GCC), DCIS outcomes are at least as favourable as some other early stage cancer types such as prostate cancer, for which active surveillance (AS) is a standard of care option. However, AS has not yet been tested in relation to DCIS. The goal of the COMET (Comparison of Operative versus Monitoring and Endocrine Therapy) trial for low-risk DCIS is to gather evidence to help future patients consider the range of treatment choices for low-risk DCIS, from standard therapies to AS. The trial will determine whether there may be some women who do not substantially benefit from current GCC and who could thus be safely managed with AS. This protocol is version 5 (11 July 2018). Any future protocol amendments will be submitted to Quorum Centralised Institutional Review Board/local institutional review boards for approval via the sponsor of the study (Alliance Foundation Trials). Methods and analysis COMET is a phase III, randomised controlled clinical trial for patients with low-risk DCIS. The primary outcome is ipsilateral invasive breast cancer rate in women undergoing GCC compared with AS. Secondary objectives will be to compare surgical, oncological and patient-reported outcomes. Patients randomised to the GCC group will undergo surgery as well as radiotherapy when appropriate; those in the AS group will be monitored closely with surgery only on identification of invasive breast cancer. Patients in both the GCC and AS groups will have the option of endocrine therapy. The total planned accrual goal is 1200 patients. Ethics and dissemination The COMET trial will be subject to biannual formal review at the Alliance Foundation Data Safety Monitoring Board meetings. Interim analyses for futility/safety will be completed annually, with reporting following Consolidated Standards of Reporting Trials (CONSORT) guidelines for non-inferiority trials. Trial registration number NCT02926911 ; Pre-results.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    Language: English
    Publisher: BMJ
    Publication Date: 2019
    detail.hit.zdb_id: 2599832-8
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  • 4
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. TPS616-TPS616
    Abstract: TPS616 Background: Approximately 50,000 women in the U.S. are diagnosed with ductal carcinoma in situ (DCIS) each year. Without treatment, it is estimated that only 20-30% of DCIS will lead to invasive breast cancer (IBC). However, over 97% of women are currently treated with surgery +/- radiation. An alternative to surgery is active monitoring (AM), a management approach in which mammograms/physical exams are used to monitor breast changes and determine when, or if, surgery is needed. The COMET Study will compare risks and benefits of AM versus surgery for low-risk DCIS in the setting of a Phase III multicenter prospective randomized trial. The study is funded by the Patient-Centered Outcomes Research Institute. The COMET trial opened in the U.S. in June 2017 (Clinicaltrials.gov reference: NCT02926911). In November 2021, the Data Safety Monitoring Board reviewed the trial and suggested that it continue as planned. Patient accrual will continue until 12/31/2022. Methods: The primary objective is to assess whether the 2-year ipsilateral IBC rate for AM is non-inferior to that for surgery. Secondary objectives include determining whether AM is non-inferior to surgery for 2-year mastectomy rate; breast conservation rate; contralateral breast cancer rate; overall and breast cancer-specific survival. Patient reported outcomes will enable comparison of health-related quality of life and psychosocial outcomes between surgery and AM groups at baseline, 6-months, and years 1-5. Eligibility criteria include: age 〉 40 at diagnosis; pathologic confirmation of grade I/II DCIS or atypia verging on DCIS without invasion by two pathologists; ER and/or PR ≥ 10%; no mass on physical exam or imaging. The accrual goal is 1200 randomized patients across 100 Alliance for Clinical Trials in Oncology sites. Sample size is estimated using a 2-group test of non-inferiority of proportions, with the 2-year IBC rate in the surgery group assumed to be 0.10 based on published studies and non-inferiority margin of 0.05. Based on a 1-sided un-pooled z-test, with alpha = 0.05, a sample size of n = 446 per group will have 80% power to detect the specified non-inferiority margin. Final analysis plan will include a per protocol component as well as a pragmatic component for patients who are randomized and decline participation in their assigned arm. Primary analyses will adjust for dropout, non-compliance and contamination by utilizing instrumental variable methods. Clinical trial information: NCT02926911.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 5
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 81, No. 4_Supplement ( 2021-02-15), p. PD5-06-PD5-06
    Abstract: Background An interactive decision support tool (DST) was adapted to support patients diagnosed with DCIS who are making treatment decisions. The DST provides the following risk estimates over 10 years: 1) future DCIS or invasive breast cancer in the same breast, 2) the risk of dying from causes other than breast cancer, and 3) the risk of dying from invasive breast cancer. Estimates are personalized based on patient age and DCIS grade (low/intermediate versus high grade or “don’t know”) and were based on a model incorporating data from clinical trials and life tables. Methods The DST was implemented in collaboration with the COMET study on the website DCISoptions.org (www.dcisoptions.org). On the DST, personalized results are displayed separately using a 100-woman icon array and percentages with each outcome (future DCIS/invasive breast cancer, death due to breast cancer, death due to other causes) in a different color for each treatment selected by the patient (lumpectomy only, lumpectomy + radiation therapy, lumpectomy + endocrine therapy, lumpectomy + radiation and endocrine therapy, mastectomy with or without reconstruction, bilateral mastectomy with or without reconstruction). In addition, information regarding active monitoring was provided in descriptive terms without icon array display of personalized outcomes. DST users were defined as those who navigated to the website and entered age and DCIS grade allowing them to access the information about expected outcomes. Users were asked to complete an optional survey both prior to use of the DST and after to assess the impact of the DST on: 1) their awareness of options for DCIS treatment, 2) their willingness to consider these options, 3) their knowledge of mortality risks associated with DCIS, and 4) how helpful the DST was to them (after use only). Results As of June 1, 2020, there were 420 users of the DST (total) with 362 completing the pre-tool survey and 58 of whom completed the post-tool survey. Among all DST users, mean age was 54.0 (9.6 years SD) and DCIS was low/intermediate for 72.0%, high for 18.5% and unknown for the remaining 9.5%. Among users who submitted both the pre- and post-tool survey, median time spent on the tool was 10.4 minutes. Awareness of each treatment option was high and did not change with the tool: 90% among both pre-survey and post-survey users except for bilateral mastectomy which remained at 82.9% among pre-survey and post-survey responders. Among those users who completed the pre- and post-tool surveys, the DST increased the percentage of patients who believed the chance of dying from DCIS is very low from 60.3% at baseline to 74.1% (p & lt;0.0001) and reduced the median estimated numerical risk of dying from DCIS in 10 years from 9.0% at baseline to 3.0% (p & lt;0.0001). A large majority of DST users found the tool very helpful or helpful (79.3% of those who responded) in making a treatment decision for DCIS. Discussion DCIS patients have been shown to greatly overestimate the risks of dying from breast cancer and this has been associated with increased anxiety and potential overtreatment. Our personalized online DST significantly improved knowledge about DCIS risks. Future studies of the DST should assess patient characteristics associated with knowledge gains and whether improved knowledge translates to improved patient outcomes including more patient preference and values-based treatment decisions. Citation Format: Rinaa Sujata Punglia, Ann Partridge, Shelley Hwang, Alastair Thompson, Elizabeth Frank, Donna Pinto, Deborah Collyar, Desiree Basila, Thomas Lynch, Terry Hyslop, Marc Ryser, Elissa Ozanne. Impact of an online ductal carcinoma in situ (DCIS) decision support tool on awareness of treatment options and knowledge of breast cancer risks [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PD5-06.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
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    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2021
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  • 6
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 83, No. 5_Supplement ( 2023-03-01), p. P6-04-13-P6-04-13
    Abstract: Introduction COMET (Comparing an Operation to Monitoring, with or without Endocrine Therapy) is a phase III clinical trial randomizing patients diagnosed with low-intermediate grade DCIS to either active monitoring or surgery. The study has a planned accrual goal of 1200 patients and is enrolling until 12/31/22. The protocol requires agreement between two pathologists (who do not need to be at the same institution) that a case fulfills COMET eligibility criteria. If there is disagreement, a third pathology review is required. As per protocol, tissue blocks or unstained slides of biopsies containing DCIS from enrolled patients are sent to a designated central location. While central pathology review is not a pre-requisite of the study, a retrospective review of received materials was performed to determine adequacy for correlative molecular and spatial profiling studies. Methods Sites submit either a tissue block or twenty (20) sequentially numbered, unstained, serial five-micron tissue sections from a diagnostic biopsy of DCIS to the Alliance Foundation Trials (AFT) central biorepository, a CAP-accredited biobank. All submitted biospecimens are de-identified (coded) and investigators are blinded to arm assignment and primary study outcomes. To evaluate the adequacy of specimens for subsequent correlative science studies, one unstained slide from each submitted slide set was stained with routine hematoxylin and eosin by the biobank, scanned at 40X magnification with an Aperio scanner, and provided to one of two expert breast pathologists for adequacy review. Slides were rated as “DCIS present”, “DCIS absent”, or “possible DCIS.” To conserve tissue, submitted tissue blocks are held in abeyance pending future correlative science planning. Results As of May 2022, tissue has been submitted from 789 of 856 eligible patients enrolled in the trial, demonstrating a very high level (92%) of case submission compliance. Despite the limiting size of such lesions and general clinical center hesitancy to release blocks for clinical trial research, tissue blocks were received from 376 of 789 (48%) of cases. Among 359 cases involving slide-only submissions that have been retrospectively reviewed to date, 294 were definite DCIS (82%), 25 (7%) were classified as possible DCIS, and 40 cases (11%) were classified as no DCIS present in the section reviewed. In no case was high grade DCIS or invasive breast cancer observed. Of the cases considered possible DCIS, atypical cells were present, but the lesions were too small or incomplete to confirm DCIS. The small percentage of cases that lacked DCIS or definite DCIS could be attributed to the receipt of a different block or subsequent (deeper) section from the same block used for the initial diagnosis. These cases were previously known to the submitting institutions. Conclusion Interim analysis at 71% accrual demonstrates both the feasibility of obtaining diagnostic biopsy material of limited size and the adequacy of these samples for subsequent correlative science studies that aim to improve pathology diagnostics and patient management. Citation Format: Rachel Factor, Stuart Schnitt, Robert West, Terry Hyslop, Thomas Lynch, Deborah Collyar, Desiree Basila, Lars Grimm, Lorraine King, Jeffrey Marks, Sunil Badve, Mark Watson, Marc Ryser, Anna Weiss, Anna Rapperport, Linda McCall, H. T. Carisa Le-Petross, Ann Partridge, E Shelley Hwang, Alastair M. Thompson. Centralized adequacy assessment of ductal carcinoma in situ samples for the COMET study (AFT-25) [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-04-13.
    Type of Medium: Online Resource
    ISSN: 1538-7445
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2023
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  • 7
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 80, No. 4_Supplement ( 2020-02-15), p. P1-21-07-P1-21-07
    Abstract: Background: Guideline-concordant care (GCC) for DCIS includes surgery, radiation, and endocrine treatment. Active surveillance (AS) is a strategy under study for management of low risk DCIS. The PORTAL Study was designed to evaluate patient reported outcomes (PROs) after GCC for DCIS compared to women who received AS for DCIS combined with women with a history of other atypical lesions (atypical ductal hyperplasia (ADH), or atypical lobular hyperplasia/lobular carcinoma in situ (LN), as proxies for AS-managed DCIS. Methods: The PORTAL Study invited women age≥ 18, diagnosed with DCIS, ADH, or LN between 2012-2017 from 4 academic centers to complete a one-time, cross-sectional survey. Clinical, pathological, and treatment information was obtained from medical record review. The primary outcome was breast/chest wall pain assessed with the Breast Cancer Pain Questionnaire (BCPQ) including severity (10-point scale, ≥3=clinically relevant), a Pain Burden Index (PBI), which is a composite of severity, frequency, and location (breast, arm, side, axilla) and assessments of sensory disturbances, and impact of pain on emotional and physical functioning. Additional PROs included measures of generalized pain (Brief Pain Inventory), anxiety (STAI-Short Form), depression (CES-D), and QOL (Quality of Life in Adult Cancer Survivors). Pain, psychosocial, and QOL outcomes were compared between the GCC vs. AS groups using Wilcoxon Rank Sum and Chi-Square tests. Results: Of 1565 patients invited and sent a survey, 927 (59%) responded to the survey with evaluable pain outcome data. Median time from diagnosis was 3.8 years. Median age at survey completion was 58 (range: 26-94) years; 13% identified as non-White; 4% Hispanic. Among those with DCIS (n=554), 97% had GCC (62%, lumpectomy, 38%, mastectomy; 48%, radiation), representing 58% of participants vs 42% representing AS. The prevalence of clinically relevant pain was higher in the GCC vs. AS group (16.5% vs 9%, p=.0009). Median BCPQ-PBI, sensory disturbance, physical, and emotional impact scores were all higher (p & lt;.0001) in the GCC vs. AS group (Table); BPI scores for pain severity and interference were similar between groups. QOL, anxiety and depressive symptoms were similar among women who had GCC compared to the AS group. Conclusion: Women with DCIS who have undergone GCC experience more breast/chest wall pain and report greater impact of pain on physical and emotional functioning in long term follow-up, compared to women who have undergone AS for DCIS or are managed for other atypical lesions. Given that many women with low risk DCIS may be unlikely to develop invasive cancer, improved understanding of the potential trade-offs of GCC vs AS can help support informed decision making in women with DCIS who are considering their treatment options. Ongoing prospective trials will provide further information regarding risks and benefits of AS vs GCC for women with low risk DCIS. BCPQ Scores, GCC vs. ASGCCASMean (range)Median (IQR)Mean (range)Median (IQR)p*PBI6.4 (0-80)0 (0-9)2.9 (0-64)0 (0-0) & lt;.0001Sensory disturbance1.4 (0-9)0 (0-2)0.6 (0-9)0 (0-0) & lt;.0001Physical impact9.6 (0-67)0 (0-19)4.4 (0-56)0 (0-0) & lt;.0001Emotional impact1.4 (0-33)0 (0-1)0.6 (0-38)0 (0-0) & lt;.0001*Wilcoxon rank sum test comparing median scores Citation Format: Shoshana M Rosenberg, Laura H Hendrix, Kristin L Schreiber, Alastair M Thompson, Isabelle Bedrosian, Kevin S Hughes, Thomas Lynch, Desiree Basila, Deborah E Collyar, Elizabeth S Frank, Sonja Darai, Conor Lanahan, Jeffrey R Marks, Jennifer K Plichta, Terry Hyslop, Ann H Partridge, E. Shelley Hwang. The Patient-reported Outcomes after Routine Treatment of Atypical Lesions (PORTAL) study: Pain, psychosocial wellbeing, and quality of life among women undergoing guideline concordant care for DCIS vs. active surveillance for in situ and atypical lesions [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-21-07.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
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    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2020
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    detail.hit.zdb_id: 1432-1
    detail.hit.zdb_id: 410466-3
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  • 8
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 81, No. 4_Supplement ( 2021-02-15), p. OT-08-02-OT-08-02
    Abstract: Background: Approximately 50,000 women in the U.S. are diagnosed with ductal carcinoma in situ (DCIS) annually. Without treatment, it is estimated that 20-30% of DCIS will lead to invasive breast cancer. Currently, more than 97% of women undergo surgery, with many also undergoing radiation. An alternative to surgery for low-risk DCIS is active monitoring (AM), an approach in which regularly scheduled mammography and physical exams are used to monitor breast changes and determine if, or when, surgery is needed. Trial design: COMET, a multicenter phase III prospective randomized trial, opened in the U.S. in June 2017 (clinicaltrials.gov reference: NCT02926911). The hypothesis is that management of low-risk DCIS using an AM approach does not yield inferior invasive breast cancer and/or quality of life outcomes compared to surgery. Eligibility criteria: Patients with a new diagnosis of unilateral, bilateral, unifocal, multifocal, or multicentric DCIS, or atypia verging on DCIS are eligible. Patients must be ≥40 years of age, have no contraindication for surgery, and pathologic confirmation of grade I/II DCIS. DCIS must be ER and/or PR≥ 10% and HER2-negative without invasion, diagnosed within 120 days of registration. Breast tissue, blood and imaging are collected at trial entry and if invasive cancer subsequently occurs, and are stored in central repositories. Specific aims: The primary aim is to assess whether the 2-yr ipsilateral invasive breast cancer rate for AM is non-inferior to surgery. Secondary aims include comparison of 2-, 5-, and 10-yr mastectomy rate, contralateral invasive breast cancer rate, overall survival and invasive breast cancer-specific survival, as well as 5- and 10-yr ipsilateral invasive breast cancer rate between groups. Patient reported outcomes (PRO) using validated tools are critical secondary endpoints, and will enable comparison of health-related quality of life and psychosocial outcomes between surgery and AM groups at prespecified time points over a period of 5 years. Statistical methods: An accrual goal of 1200 was estimated using a 2-group test of noninferiority of proportions, with the 2-yr invasive breast cancer rate in the surgery group assumed to be 0.10, including accounting for upstaging. The projected drop-out rate is 25%, for a total of 900 patients treated per allocation arm. The non-inferiority boundary was set at 0.05. Based on a 1-sided un-pooled z-test, with alpha=0.05, a sample size of n=446 per group will have 80% power to detect the specified noninferiority margin. Intention-to-treat analysis of the 2-yr invasive breast cancer rate will be conducted using all patients as randomized, and will be completed using Kaplan-Meier estimates, stratified by group, combined with Greenwood’s confidence interval. Several sensitivity analyses (per protocol, as-treated, and instrumental variable) are also planned to account for loss of follow-up, rejection of randomization allocation and withdrawals. Present and target accrual: Trial accrual as of 7/1/20 is 540 randomized patients from 84 activated Alliance for Clinical Trials in Oncology sites. Despite logistical challenges posed by the COVID-19 crisis, patients continue to be recruited to the COMET trial. Over 80% of patients have sample sets/images stored in the tissue and image repositories. This trial will provide definitive clinical, quality of life and biomarker evidence regarding the trade-offs of surgery vs AM in patients with low-risk DCIS. Support: CER-1503-29572; https://acknowledgments.alliancefound.org Contact: Thomas Lynch (Project Manager) - thomas.lynch2@duke.edu Citation Format: Thomas Lynch, Ann Partridge, Alastair Thompson, Elizabeth Frank, Donna Pinto, Deborah Collyar, Desiree Basila, Louise Davies, Jenny Donovan, Terry Hyslop, Linda McCall, Marc Ryser, Taylor O' Donnell, Anna Weiss, Shelley Hwang. Comparing an operation to monitoring, with or without endocrine therapy (COMET): A prospective randomized trial for low-risk DCIS (AFT-25) [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr OT-08-02.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
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    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2021
    detail.hit.zdb_id: 2036785-5
    detail.hit.zdb_id: 1432-1
    detail.hit.zdb_id: 410466-3
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  • 9
    In: Cancer Prevention Research, American Association for Cancer Research (AACR), Vol. 15, No. 12_Supplement_1 ( 2022-12-01), p. A011-A011
    Abstract: Introduction: Treatment options for women diagnosed with DCIS require careful consideration of the potential risks and benefits. An interactive decision support tool (DST) was developed to provide information about these options, including their potential long-term risk. The DST was implemented through the website www.dcisoptions.org in collaboration with the AFT-25 Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET), for low-risk DCIS study. Methods: The DST provides personalized prediction of the potential clinical impact of six different treatment options over a 10-year period. Women were asked to select one or more option, and to complete two surveys - one prior to interacting with the DST and one following interaction. Chi-square tests were used to compare the distribution of age group and DCIS grade among women who completed both surveys and those who completed the pre-tool survey only. Mean age was compared using the t-test and median age was compared using the Wilcoxon-Mann-Whitney test. The signed-rank test was used to compare the median age. The cohort that answered both surveys was analyzed for potential differences in response (pre- versus post-tool). The McNemar test was used to compare percentage distributions and the paired t-test was used to compare mean responses for questions using the Likert scale. A signed rank test was used to compare median changes from pre- to post-tool. Statistical significance was defined as P & lt;0.05 in a two-sided test. The primary endpoint of the study was to evaluate the effectiveness of the DST in communicating information about DCIS treatment options and related risk predictions. Results: Data were collected from January 2019 to April 2022 for women (non-COMET participants) who completed the DST. Of those 976 women, 831 (85%) completed the pre-tool survey only and 145 (15%) completed both the pre- and post-tool survey. The mean age was 54.4 (9.8 SD) years. 73% of women had low/intermediate-grade DCIS, while 19% had high-grade DCIS. Among women who submitted both surveys, average time spent completing the DST was 10 minutes. Awareness of the treatment options prior to use of the DST was high (90%), except for active surveillance (85.2%) and bilateral mastectomy (84.3%). Awareness post-tool did not change significantly except for active surveillance (85.2% to 96.5% (p=0.004)). Among women who completed both surveys, the percentage who correctly identified that the chance of dying from DCIS is ‘Very Low’ increased from 60.0% to 73.8% (p & lt;0.0001). The median estimated risk of dying from DCIS in 10 years decreased from 9% to 3% (p & lt;0.0001). A total of 101/132 (76.5%) women that responded to a specific question about the DST found it to be ‘Very Helpful’ or ‘Helpful’ in making a treatment decision for DCIS. A limitation of the study is the lower response rate to the post-tool survey. Conclusion: In this study, we demonstrated that utilization of a DST by women diagnosed with DCIS may enable value-congruent decision making and potentially result in improved patient outcomes. Citation Format: Thomas Lynch, Ann Partridge, E. Shelley Hwang, Alastair Thompson, Elizabeth Frank, Donna Pinto, Deborah Collyar, Desiree Basila, Terry Hyslop, Marc Ryser, Anna Weiss, Anna Rapperport, Rinaa Punglia, Elissa Ozanne. Effectiveness of an online decision support tool in communicating information about treatment options and related risks for ductal carcinoma in situ (DCIS) [abstract]. In: Proceedings of the AACR Special Conference on Rethinking DCIS: An Opportunity for Prevention?; 2022 Sep 8-11; Philadelphia, PA. Philadelphia (PA): AACR; Can Prev Res 2022;15(12 Suppl_1): Abstract nr A011.
    Type of Medium: Online Resource
    ISSN: 1940-6215
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2022
    detail.hit.zdb_id: 2422346-3
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