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273 citation(s) found for "Loprinzi, CL".

Slow Uptake of an Effective Therapy: Patterns of Olanzapine Prescribing for Those Receiving Highly Emetogenic Chemotherapy
Childs, Daniel S. , Helfinstine, David A. , Sangaralingham, Lindsey R. , Orme, Jacob J. , O’Sullivan, Ciara C. , Loprinzi, Charles L. , Ruddy, Kathryn J. , Sangaralingham, Lindsey, Childs, Daniel S

Mayo Clinic

JCO Oncology Practice | October 31, 2022 | Volume: 18 | Issue: 12 | Pages: e1953-e1960

10.1200/op.22.00389 | PMID 36315918 Get It

PURPOSE: For the past 5 years, most major antiemesis guidelines have included olanzapine-containing regimens among the recommended options for prophylaxis with highly emetogenic chemotherapy (HEC). We analyzed the uptake of olanzapine in clinical practice and the changing composition of multidrug antiemetic regimens. METHODS: A retrospective analysis was performed using an OptumLabs deidentified database of medical and pharmacy claims, which was filtered for patients starting HEC in the interval of 2006 to Q2 of 2021. Descriptive statistics were used to analyze patient characteristics and year-by-year antiemetic prescribing patterns, coinciding with cycles 1 and 2 of chemotherapy. RESULTS: A total of 63,154 distinct patients were included. The median age was 58 years (range, 18-88). Breast (45.2%) and hematologic (20.8%) cancers were the most common diagnoses. In 2016, olanzapine was prescribed to 1.4% of patients with cycle 1 of HEC. Prescriptions increased modestly each year, and by 2021, 13.9% of patients received olanzapine with their first cycle of chemotherapy. An additional 5.7% of patients received olanzapine for breakthrough symptoms or enhanced prophylaxis during cycle 2. In 2021, more than three-quarters of patients were prescribed antiemetics in a guideline-concordant manner, with an olanzapine-containing quadruplet (12.2%), an NK1-receptor antagonist triplet (64.5%), or an olanzapine triplet (suppressed for small sample size). CONCLUSION: Despite inclusion in major antiemesis guidelines, there has been relatively slow uptake of olanzapine for prophylaxis with HEC. This finding highlights the challenges of disseminating information and keeping prescribing systems updated with the newest evidence in supportive oncology.
Patterns of olanzapine prescribing for those receiving highly emetogenic chemotherapy.
Helfinstine, David A. , Sangaralingham, Lindsey R. , Orme, Jacob J. , O’Sullivan, Ciara C. , Loprinzi, Charles L. , Ruddy, Kathryn J. , Childs, Daniel S.

Mayo Clinic

Journal of Clinical Oncology | September 30, 2022 | Volume: 40 | Issue: 28_suppl | Pages: 232-232

10.1200/jco.2022.40.28_suppl.232 Get It

232 Background: Olanzapine has an important role in preventing and treating nausea and vomiting from highly emetogenic chemotherapy (HEC). This drug, for the last 5 years, has been a component of most major antiemesis guidelines. The aim of the current study was to assess how often olanzapine has been prescribed for patients receiving HEC. Methods: A retrospective analysis was performed using an OptumLabs de-identified clinical database of medical and pharmacy claims. The database was filtered for patients starting HEC in the interval of 2006 to Q2 of 2021. Descriptive statistics were used to analyze patient characteristics and year-by-year antiemetic prescribing patterns, coinciding with cycles 1 and 2 of chemotherapy. Results: A total of 63,154 distinct patients were included. The median age was 58 years (range, 18-88). Over a quarter of the patients identified as Black, Hispanic, Asian, or other. Breast (45.2%) and hematologic (20.8%) cancers were the most common diagnoses. In 2016, olanzapine was prescribed to only 1.4% of patients with cycle 1 of HEC. Prescriptions increased modestly each year, and by 2021, 13.9% of patients received olanzapine with their first cycle of chemotherapy. An additional 5.7% of patients received olanzapine for breakthrough symptoms or enhanced prophylaxis during cycle 2. In 2021, over three-quarters of patients were prescribed antiemetics in a guideline concordant manner, with either an olanzapine-containing quadruplet (12.2%), an NK1 receptor antagonist triplet (64.5%), or an olanzapine triplet (exact number suppressed due to small sample size). Conclusions: The rate of olanzapine prescribing is less than might be expected following its inclusion in major antiemesis guidelines. This finding highlights the challenges of disseminating information and keeping prescribing systems updated with the newest evidence in supportive oncology.
Integrative Medicine for Pain Management in Oncology: Society for Integrative Oncology–ASCO Guideline
Mao, Jun J. , Ismaila, Nofisat , Bao, Ting , Barton, Debra L. , Ben‐Arye, Eran , Garland, Eric L. , Greenlee, Heather , LeBlanc, Thomas W. , Lee, Richard T. , López, Ana María , Loprinzi, Charles L. , MacLeod, Jodi , Master, Viraj A. , Ramchandran, Kavitha , Walker, Eleanor , Witt, Claudia M. , Barton, Debra , Leblanc, Thomas , Loprinzi, Charles , Lyman, Gary H , MacLeod, Jodi , Wagner, Lynne , Bruner, Deborah , Witt, Claudia M , Bruera, Eduardo , Mao, Jun J , Ramchandran, Kavitha J , Wagner, Lynne I. , Bruner, Deborah Watkins

Mayo Clinic

Journal of Clinical Oncology | September 19, 2022 | Volume: 40 | Issue: 34 | Pages: 3998-4024

10.1200/jco.22.01357 | PMID 36122322 Get It

PURPOSE The aim of this joint guideline is to provide evidence-based recommendations to practicing physicians and other health care providers on integrative approaches to managing pain in patients with cancer. METHODS The Society for Integrative Oncology and ASCO convened an expert panel of integrative oncology, medical oncology, radiation oncology, surgical oncology, palliative oncology, social sciences, mind-body medicine, nursing, and patient advocacy representatives. The literature search included systematic reviews, meta-analyses, and randomized controlled trials published from 1990 through 2021. Outcomes of interest included pain intensity, symptom relief, and adverse events. Expert panel members used this evidence and informal consensus to develop evidence-based guideline recommendations. RESULTS The literature search identified 227 relevant studies to inform the evidence base for this guideline. RECOMMENDATIONS Among adult patients, acupuncture should be recommended for aromatase inhibitor–related joint pain. Acupuncture or reflexology or acupressure may be recommended for general cancer pain or musculoskeletal pain. Hypnosis may be recommended to patients who experience procedural pain. Massage may be recommended to patients experiencing pain during palliative or hospice care. These recommendations are based on an intermediate level of evidence, benefit outweighing risk, and with moderate strength of recommendation. The quality of evidence for other mind-body interventions or natural products for pain is either low or inconclusive. There is insufficient or inconclusive evidence to make recommendations for pediatric patients. More research is needed to better characterize the role of integrative medicine interventions in the care of patients with cancer. Additional information is available at https://integrativeonc.org/practice-guidelines/guidelines and www.asco.org/survivorship-guidelines .
Resuscitation code status among emergency department patients: decision support education video pilot study
Finch, Alexander S , Stanich, Jessica A. , Spadaro, Maria J, Tschautscher, Craig F., Walker, Laura , Brauer, Caitlin E. Loprinzi, Finch, Alexander S. , Tschautscher, Craig F.

Mayo Clinic

BMJ Supportive & Palliative Care | September 5, 2022 | Volume: 14 | Issue: e1 | Pages: e492-e495

10.1136/spcare-2022-003538 Get It

Objectives Establishment of code status can be challenging in the acute care setting. The primary objective of the present study was to evaluate whether patients or their surrogate decision-makers were comfortable watching an educational video about resuscitation. Methods This interventional pilot study involved a pre- and a postintervention survey of a convenience sample of emergency department (ED) patients who were admitted to the hospital. The study was conducted at an academic level-1 trauma centre within the normal flow of patient care over 4 months in 2017. Results In total, 50 patients enrolled in the study. Among them, 82% were ‘very comfortable’ and 14% were ‘moderately comfortable’ watching the video. Overall, 61% of respondents were ‘very comfortable’ recommending the video to others. Watching the video resulted in a change in code status for 9 patients. Conclusions Our results indicate that patients felt comfortable watching the video and recommending the video for further use. Watching the video did not result in a change in code status for most patients in this study. The study results indicate that a standardised patient education video on resuscitation code status was acceptable to patients and their family members and has potential for increased use in the ED.
Factors Associated With Physical Activity Levels in Patients With Breast Cancer
Marell, Paulina S. , Herrmann, Joerg , D’Andre, Stacy D, Cheville, Andrea , Barksdale, Toure, Loprinzi, Charles L. , Ruddy, Kathryn J. , Cheville, Andrea L , Ruddy, Kathryn J , Vierkant, Robert A. , Olson, Janet E. , Larson, Nicole , LeBrasseur, Nathan K. , Barksdale, Touré, Couch, Fergus J.

Mayo Clinic

The Oncologist | August 10, 2022 | Volume: 27 | Issue: 10 | Pages: e811-e814

10.1093/oncolo/oyac159 | PMID 35946834 Get It

Abstract Physical activity (PA) is associated with improvement in breast cancer treatment-related symptoms and survival, yet most breast cancer survivors do not meet national PA guidelines. This study aimed to identify characteristics of participants that were associated with an increased likelihood of meeting PA guidelines. Adults with breast cancer seen at Mayo Clinic (Rochester, MN) were surveyed regarding their PA participation, and those who self-reported at least 150 minutes of moderate and/or strenuous aerobic PA weekly on average were considered to be “meeting guidelines”. Three thousand participants returned PA data. Younger age, completion of the survey 7-12 years after diagnosis, absence of recurrence, no bilateral mastectomy, absence of metastatic disease, and lower BMI at the time of survey completion were associated with PA participation (P < .05 in univariate and multivariate analyses). Findings were similar when a threshold of 90 minutes was applied. These results may inform the development of targeted PA-facilitating interventions.
A Global Survey on the Utilization of Cryotherapy and Compression Therapy for the Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chan, Alexandre , Elsayed, Amna, Ng, Ding Quan , Ruddy, Kathryn J. , Loprinzi, Charles L. , Lustberg, Maryam B.

Mayo Clinic

No container title available | June 27, 2022 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.21203/rs.3.rs-1757410/v1 Get It

Abstract Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a serious side effect that is highly prevalent among cancer patients undergoing chemotherapy. There is a growing use of cryotherapy (CryTx) and compression therapy (ComTx) to prevent CIPN at cancer centers worldwide. In this study, we examined the awareness and recommendation of these modalities and evaluated factors associated with awareness. In addition, we investigated the type of technology utilized, barriers to implementation, and perceived adverse events of CryTx and ComTx.Methods: Active members of the Multinational Association of Supportive Care of Cancer (MASCC) were invited to complete an electronic survey that was sent via SurveyMonkey between September to October 2021. The survey assessed participants’ awareness, recommendation, usage, barriers to utilization, and perceived adverse events of CryTx and ComTx. Descriptive statistics and multiple logistic regression were utilized to analyze findings.Results: Out of 184 participants, 70.1% were physicians, 73.4% had over 10 years of practice, and 49.5% were practicing in an outpatient setting. While more than half (63.3%) of participants indicated awareness of CryTx for taxane-induced peripheral neuropathy, less than a quarter (22.8%) indicated recommendation in their practice setting. Factors associated with higher awareness of CryTx for patients receiving taxanes include living in Europe (OR=2.69, 95% CI [1.28-5.64], p=0.009), not practicing in an inpatient setting (OR=3.15, 95% CI [1.45-6.85], p=0.004), and self-identifying as non-physician (OR=2.40, 95% CI [1.03-4.37], p=0.041). Commercial cooling (31.5%) and compression (16.8%) gloves and socks were the most used modalities for CryTx and ComTx, respectively. The most identified barriers to CryTx and ComTx utilization include insufficient evidence (53.5%), logistics (34.8%), and patient discomfort (23.4%). Redness/irritation of skin (27.7%) and numbness/tingling (24.5%) accounted for about half of the perceived adverse events associated with use of CryTx and ComTx. Conclusion: Results of our global survey illustrated that there are varying modes in the delivery of CryTx and ComTx among cancer centers around the world. Education of the utilization of CryTx and ComTx, in addition to efficacy and implementation studies, are needed to close the gap between awareness and implementation in clinical practice.
Abstract 5262: Physical function, mental health, and overall health of older breast cancer survivors
Karam, Dhauna , Ehlers, Shawna L. , Loprinzi, Charles L. , Ruddy, Kathryn J. , Vierkant, Robert A. , Freedman, Rachel A. , Larson, Nicole, Couch, Fergus J. , Olson, Janet E.

Mayo Clinic

Cancer Research | June 15, 2022 | Volume: 82 | Issue: 12_Supplement | Pages: 5262-5262

10.1158/1538-7445.am2022-5262 Get It

Abstract Introduction: Patients at extremes of age may be particularly vulnerable to poor physical and mental health after treatment for breast cancer; we examined factors associated with poor health in older breast cancer survivors. Methods: The Mayo Clinic Breast Disease Registry (MCBDR) is a prospective longitudinal cohort study that enrolls Mayo Clinic Rochester patients diagnosed with stage 0-4 breast cancer (BC). In 2020, we mailed a survey to 1,273 MCBDR participants aged 77+. Three PROMIS-10 items were used to assess overall health, mental health, and physical function. Self-reported comorbidities were also collected. Multivariate logistic regression analysis was used to identify significant (p<0.05) predictors of overall health, mental health, and physical function. Independent variables included demographics, clinical characteristics, and comorbidities. Results: 848/1273 MCBDR participants (67%) responded, 842 reporting their overall health. Median age at survey return was 82 years (range 77-100), and the median time since cancer diagnosis was 12 years. Excellent or very good overall health, mental health, and physical function were reported by 48%, 63.5%, and 77.1%, respectively. Older age was associated with poorer self-reported overall health, as were heart disease, diabetes, and lung disease, reported by 18%, 14%, and 7%, respectively (p<0.05 for all; see Table). Only heart disease was statistically significantly associated with poorer mental health (p=0.03). Physical function was reportedly better in survivors without a history of diabetes, stroke, or lung disease (p<0.05 for all), and in those who were closer to their cancer diagnosis (p=0.03). Tumor characteristics were not associated with overall health, mental health, or physical function. Conclusions: Comorbidities are common and impact self-reported overall health, mental health, and physical function in older breast cancer survivors. Table: Multivariate logistic regression model for overall health Overall health self-reported as excellent or very good No Yes Total p-value (N=437) (N=405) (N=842) Age at survey (years) <.001 Mean (SD) 82.8 (4.22) 81.7 (3.85) 82.3 (4.08) Median (range) 82.0 (77.0, 96.0) 81.0 (77.0, 100.0) 82.0 (77.0, 100.0) Years from cancer diagnosis to survey 0.708 Mean (SD) 12.1 (5.16) 11.8 (5.47) 11.9 (5.31) Median (range) 12.2 (3.1, 36.9) 11.5 (3.1, 36.4) 12.0 (3.1, 36.9) T stage T2 or higher, n (%) 0.276 No 357 (81.7%) 337 (83.2%) 694 (82.4%) Yes 80 (18.3%) 68 (16.8%) 148 (17.6%) N stage N1 or higher, n (%) 0.185 No 376 (86.0%) 339 (83.7%) 715 (84.9%) Yes 61 (14.0%) 66 (16.3%) 127 (15.1%) M stage M1, n (%) 0.313 No 434 (99.3%) 404 (99.8%) 838 (99.5%) Yes 3 (0.7%) 1 (0.2%) 4 (0.5%) Race, n (%) 0.460 Non-White 13 (3.0%) 8 (2.0%) 21 (2.5%) White 424 (97.0%) 397 (98.0%) 821 (97.5%) Heart disease, n (%) <.001 No 334 (76.4%) 353 (87.2%) 687 (81.6%) Yes 103 (23.6%) 52 (12.8%) 155 (18.4%) High blood pressure, n (%) 0.376 No 168 (38.4%) 188 (46.4%) 356 (42.3%) Yes 269 (61.6%) 217 (53.6%) 486 (57.7%) Stroke, n (%) 0.195 No 407 (93.1%) 392 (96.8%) 799 (94.9%) Yes 30 (6.9%) 13 (3.2%) 43 (5.1%) Diabetes, n (%) <.001 No 355 (81.2%) 370 (91.4%) 725 (86.1%) Yes 82 (18.8%) 35 (8.6%) 117 (13.9%) Lung disease, n (%) 0.023 No 394 (90.2%) 386 (95.3%) 780 (92.6%) Yes 43 (9.8%) 19 (4.7%) 62 (7.4%) Liver disease, n (%) 0.345 No 425 (97.3%) 401 (99.0%) 826 (98.1%) Yes 12 (2.7%) 4 (1.0%) 16 (1.9%) Kidney disease, n (%) 0.240 No 408 (93.4%) 392 (96.8%) 800 (95.0%) Yes 29 (6.6%) 13 (3.2%) 42 (5.0%) Citation Format: Dhauna Karam, Robert A. Vierkant, Shawna Ehlers, Rachel A. Freedman, Nicole Larson, Charles L. Loprinzi, Fergus Couch, Janet Olson, Kathryn J. Ruddy. Physical function, mental health, and overall health of older breast cancer survivors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 5262.
Abstract 5868: Factors associated with exercise participation in patients with breast cancer
Marell, Paulina S. , Herrmann, Joerg , Larson, Nicole L. , D’Andre, Stacy D. , Barksdale, Toure, Loprinzi, Charles L. , Ruddy, Kathryn J. , Olson, Janet E. , LeBrasseur, Nathan K. , Cheville, Andrea , Barksdale, Touré, Couch, Fergus J.

Mayo Clinic

Cancer Research | June 15, 2022 | Volume: 82 | Issue: 12_Supplement | Pages: 5868-5868

10.1158/1538-7445.am2022-5868 Get It

Abstract BACKGROUND: The American Cancer Society recommends at least 150 minutes of moderate and/or strenuous exercise and muscle-strengthening activities each week for adults. Exercise has been associated with decreased breast cancer mortality and adverse symptoms. This study’s purpose is to understand prevalence and predictors of inadequate aerobic exercise in patients recently diagnosed with breast cancer to inform interventions to increase exercise participation. METHODS: Patients seen at least once at Mayo Clinic Rochester were prospectively enrolled within one year of an initial breast cancer diagnosis in the Mayo Clinic Breast Disease Registry after providing informed consent. This analysis includes those who completed a baseline survey with self-reported exercise data using the Godin Leisure-Time Exercise Questionnaire. This longitudinal cohort study was approved by the Mayo Clinic institutional review board. RESULTS: 1,738 participants reported their usual weekly quantity of moderate and strenuous exercise an average of 95 days (SD 71 days, range 0-365) after diagnosis. Table 1 displays participant characteristics overall and by whether participants reported at least 150 minutes of moderate and/or strenuous activity weekly (“met guidelines”) or not (“did not meet guidelines”). Overall, 39% of participants met guidelines, including 56% of those aged 18-39 years, 40% of those aged 40-69 years, and 27% of those aged 70+ years. CONCLUSION: Older age was associated with less likelihood of meeting exercise guidelines (all age groups vs 70+, p < 0.05). A more diverse cohort will be needed to evaluate differences by gender and race/ethnicity. There did not appear to be any obvious impact on exercise level by time since diagnosis (during the first year after diagnosis) or educational status, though substantial missing data limit conclusions related to the latter. Additional research is needed to assess exercise levels later in survivorship and the impact of various treatment modalities on exercise habits Table 1. Patient and tumor characteristics Citation Format: Paulina S. Marell, Janet E. Olson, Joerg Herrmann, Nicole L. Larson, Nathan K. LeBrasseur, Stacy D. D'Andre, Andrea L. Cheville, Toure Barksdale, Charles L. Loprinzi, Fergus J. Couch, Kathryn J. Ruddy. Factors associated with exercise participation in patients with breast cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 5868.
Abstract 1012: Financial hardship in breast cancer survivors
Loprinzi, Charles L. , Khera, Nandita , Ruddy, Kathryn J. , Storandt, Michael H. , Durani, Urshila , Stan, Daniela , Larson, Nicole, Couch, Fergus J. , Olson, Janet E.

Mayo Clinic

Cancer Research | June 15, 2022 | Volume: 82 | Issue: 12_Supplement | Pages: 1012-1012

10.1158/1538-7445.am2022-1012 Get It

Abstract Background: Medical financial hardship, encompassing material, behavioral, and psychologic domains, is becoming an increasingly common consequence of illness in cancer patients. Identifying at-risk patients is the first step to develop proactive approaches to mitigate this problem. To try and address this need, Mayo Clinic Breast Disease Registry (MCBDR) is prospectively collecting data about financial concerns in addition to the usual sociodemographic and clinical information. Methods: We used data from Mayo Clinic Breast Disease Registry, a prospective cohort of consenting patients seen at Mayo Clinic Rochester within one year of initial breast cancer diagnosis. Participants completed baseline and annual follow-up surveys rating their financial concerns on a linear analogue scale from 0 (“none”) to 10 (“constant concerns”). We compared patient-reported financial concern at baseline to that on each patient’s most recent survey, with worsening concerns defined as a 1+-point increase. Logistic regression evaluated for predictors of worsening financial concerns. Results: 1,957 participants responded to financial concern questions on a baseline and at least one follow-up survey between 2015 and 2020. Mean age was 58.5 years (SD 12.5), and mean time between diagnosis and the most recent follow-up was 25.6 months (SD 16.2). 357 (18.2%) reported worsening financial concerns. Only lower baseline financial status was associated with a greater likelihood of worsening financial concerns (see Table). Conclusions: More than one in seven breast cancer survivors develop worsening financial concerns within 5-years of diagnosis, and those with less financial security at baseline appear to be most vulnerable. Funding: Breast Cancer Research Foundation (CLL) and NR015259 (KJR). Patient and tumor characteristics, compared by whether financial status worsened over time Full Cohort (n=1957) Worsening, ≥ 1-point change (n=357) Stable/Improved (n=1600) p value Full Cohort (n=1957) Worsening, ≥ 1-point change (n=357) Stable/Improved (n=1600) p value Age at diagnosis II or III 502 (25.7%) 98 (27.5%) 404 (25.3%) 0.239 ≤ 50 546 (27.9%) 105 (29.4%) 441 (27.6%) IV 67 (3.4%) 17 (4.8%) 50 (3.1%) 0.086 51-64 757 (38.7%) 136 (38.1%) 621 (38.8%) 0.562 Unknown 351 (17.9%) 65 (18.2%) 286 (17.9%) 0.536 ≥65 654 (33.4%) 116 (32.5%) 538 (33.6%) 0.506 ER and/or PR positive Race No/Unknown 482 (24.6%) 92 (25.8%) 390 (24.4%) White 1863 (95.2%) 337 (94.4%) 1526 (95.4%) Yes 1475 (75.4%) 265 (74.2%) 1210 (75.6%) 0.580 Non-white 24 (1.2%) 5 (1.4%) 19 (1.2%) 0.729 Her2 positive Other/Unknown/Choose not to respond 70 (3.6%) 15 (4.2%) 55 (3.4%) 0.478 No/Unknown 1746 (89.2%) 314 (88.0%) 1432 (89.5%) Educational status Yes 176 (9.0%) 37 (10.4%) 139 (8.7%) 0.321 Less than bachelor’s degree 880 (45.0%) 168 (47.1%) 712 (44.5%) Borderline 35 (1.8%) 6 (1.7%) 29 (1.8%) 0.898 Bachelor's degree or higher 1065 (54.4%) 187 (52.4%) 878 (54.9%) 0.384 Radiation Unknown 12 (0.6%) 2 (0.6%) 10 (0.6%) 0.832 No/Unknown 781 (39.9%) 140 (39.2%) 641 (40.1%) Financial status near time of diagnosis Yes 1176 (60.1%) 217 (60.8%) 959 (59.9%) 0.768 Pay bills, money for special things 1412 (72.2%) 244 (68.3%) 1168 (73.0%) Chemotherapy/targeted therapy Pay bills, no money for special things 367 (18.8%) 80 (22.4%) 287 (17.9%) 0.046 No/Unknown 1264 (64.6%) 221 (61.9%) 1043 (65.2%) Pay bills by making cuts 102 (5.2%) 19 (5.3%) 83 (5.2%) 0.729 Yes 693 (35.4%) 136 (38.1%) 557 (34.8%) 0.241 Unable to pay bills 56 (2.9%) 10 (2.8%) 46 (2.9%) 0.911 Hormone/endocrine therapy Unknown 20 (1.0%) 4 (1.1%) 16 (1.0%) 0.750 No/Unknown 710 (36.3%) 141 (39.5%) 569 (35.6%) Employment status at time of diagnosis Yes 1247 (63.7%) 216 (60.5%) 1031 (64.4%) 0.163 Employed full-time 462 (23.6%) 83 (23.2%) 379 (23.7%) Surgery type Employed part-time/unemployed/retired 525 (26.8%) 92 (25.8%) 433 (27.1%) 0.856 Lumpectomy 846 (43.2%) 145 (40.6%) 701 (43.8%) Not available 970 (49.6%) 182 (51.0%) 788 (49.3%) 0.716 Mastectomy 903 (46.1%) 165 (46.2%) 738 (46.1%) 0.535 Stage at time of diagnosis None/Unknown 208 (10.6%) 47 (13.2%) 161 (10.1%) 0.069 0 or I 1037 (53.0%) 177 (49.6%) 860 (53.8%) Citation Format: Michael H. Storandt, Urshila Durani, Daniela Stan, Nicole Larson, Charles Loprinzi, Fergus Couch, Janet E. Olson, Nandita Khera, Kathryn J. Ruddy. Financial hardship in breast cancer survivors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 1012.
Shortening the baseline period in hot flash symptom control trials: Comparison of a one-day versus seven-day baseline hot flash diary.
Novotny, Paul J. , Marrell, Paulina S, Ruddy, Kathryn J. , Loprinzi, Charles L. , Childs, Daniel S.

Mayo Clinic

Journal of Clinical Oncology | June 6, 2022 | Volume: 40 | Issue: 16_suppl | Pages: e24094-e24094

10.1200/jco.2022.40.16_suppl.e24094 Get It

e24094 Background: Hundreds, if not thousands, of participants are enrolled hot flash trials each year given the magnitude of the problem for breast and prostate cancer survivors. Classically, these studies have included a baseline period of 1-week, or longer, to understand the frequency and severity of hot flashes before starting a new treatment. The objective of the current study was to compare the accuracy of a 1-day baseline hot flash diary to a more traditional 1-week dairy. A shorter baseline period would be more convenient for patients and provide a more efficient study design. Methods: Raw data from 5 pilot studies and 15 phase III randomized, controlled trials (RCTs), all of which used a one-week baseline period, were obtained. Descriptive statistics were used to describe day-by-day variations in hot flash frequencies and scores, during the baseline week. Additional analyses evaluated whether the conclusions from any of the individual pilot studies would have been changed if only a 1-day baseline period had been used. For the RCTs, p-values were recalculated using mixed models, adjusting for the baseline value by including it as a covariate. Results: A total of 2,573 participants were included. On average, participants had 8.5 hot flashes per day on Day 1. Mean hot flash frequencies and scores on subsequent days (Days 2-7) were within 6% of Day 1 values. When comparing a 1-day to a 1-week baseline period, there was an absolute difference of only 0.29 hot flashes per day (SD 2.25). Re-analysis for each pilot study revealed that no individual study conclusions would have been meaningfully altered by a shorter baseline. For the RCTs, a shorter baseline period changed the results of only 1 of 24 comparisons from statistically significant to not significant, or vice versa. Conclusions: A 1-day hot flash diary appears to accurately reflect true frequency and severity of baseline hot flash symptoms in appropriately sized cohorts. Results support a shorter baseline period for pilot studies and RCTs.