Validation of the NCI patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) in women receiving treatment for metastatic breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9144-9144
Author(s):  
Sandra A. Mitchell ◽  
Kathy Lang ◽  
Christine Nichols ◽  
Steven B. Clauser ◽  
Victoria Federico ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Construct Validity ◽  
Metastatic Breast ◽  
Weighted Kappa ◽  
Symptomatic Treatment ◽  
Self Report ◽  
Symptom Dimensions ◽  
Cancer Support ◽  
Patient Reported

9144 Background: NCI PRO-CTCAE is designed to enhance adverse event reporting by integrating patients’ self-report of the frequency (F), severity (S) and interference (I) with usual activities of 78 symptomatic treatment toxicities. This study examined the construct validity of a subset of PRO-CTCAE items in women with metastatic breast cancer (MBC). Methods: 207 women (70% aged 45-59 years; 94% White;71% college-educated) with HER2+ MBC who had received treatment in the past month were recruited from 6 U.S. breast cancer support groups and completed a web survey that collected 18 PRO-CTCAE symptoms, and the Rotterdam Symptom Checklist (RSC). Pairwise concordance among PRO-CTCAE symptom dimensions was examined using weighted Kappa and Bowker’s test for symmetry. Results: Respondents were a median of 47 months since MBC diagnosis and 61% rated their health-related quality of life (HRQL) as good to excellent. Symptom prevalence was similar for PRO-CTCAE and RSC, with respondents more likely to endorse mood disturbance on PRO-CTCAE (Anxiety/Worry 90%; Sad/Unhappy Feelings 86%) vs. RSC (Anxiety 63%; Depressed Mood 61%). There was parallel rank-ordering of fatigue, anxiety, insomnia, depression, difficulty concentrating and neuropathy as the symptoms that were most severe, interfered most and caused the greatest bother. Within PRO-CTCAE, pairwise agreement among F, S and I was moderate for most symptoms (κw=.42 to .54). Agreement between F and S was highest for pain, nausea and arm/leg swelling (κw=.61 to .80), and lowest for anxiety/worry and sad/unhappy feelings (κw= .27-.37). Except for arm/leg swelling, endorsement patterns by the dimensions of F, S and I were distinct (Bowker’s p all <.002). Across PRO-CTCAE symptoms, S was consistently higher than I (mean differences .12 to .72, all p<.01]). Means for S were consistently and significantly higher for those with impaired versus preserved HRQL, providing evidence of construct validity. Conclusions: This study supports the construct validity of PRO-CTCAE, and suggests that F, S and I dimensions offer non-overlapping information relative to 17 /18 PRO-CTCAE symptomatic toxicities.

How can palliative care specialists best integrate into multidisciplinary oncology care for patients with metastatic breast cancer?

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 182-182
Author(s):  
Tara Laura Kaufmann ◽  
Melissa F Miller ◽  
Joanne S. Buzaglo ◽  
Arif Kamal
Keyword(s):  
Breast Cancer ◽  
Palliative Care ◽  
Metastatic Breast Cancer ◽  
Metastatic Cancer ◽  
Metastatic Breast ◽  
Current Evidence ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Cancer Support ◽  
Patient Reported

182 Background: Current evidence for palliative care/oncology integration derives from cancers with either very short prognoses or relatively limited treatment options (e.g. pancreas). Little is know about the role of palliative care in metastatic breast cancer, where prognosis may be measured in years and the treatment option portfolio is continuously expanding. Methods: The Cancer Support Community Metastatic Breast Cancer Experience Registry is a voluntary, patient-reported, online registry of patient experiences with cancer. We evaluated data reported by patients from March 2013 to March 2014. The registry includes demographic information and data regarding physical, emotional, social, and financial distress measured using Likert scales. We calculated descriptive statistics and Pearson’s chi-squared. Results: We evaluated 599 patients. The sample median age was 56; 93% were White; 61% had a bachelor’s degree or higher Median time from diagnosis of metastatic cancer was 3 years. Regarding physical distress, over 50% reported “moderate” or higher issues with sleep, nutrition and eating, and fatigue. Depression and anxiety prevalence increased by 15% and 20%, respectively, from pre-treatment to post-treatment. Among social distress, 25% felt alone, 62% worried about burdening their family, and over 50% limited contact with others. 30% or higher desired more assistance with: diagnostic and treatment information, making decisions, managing symptoms and emotions, and managing disruptions to family and work life. Respondents were more likely to have been asked about distress if they received part or all of their care at an academic or comprehensive cancer center (p < 0.001) or treatment through a clinical trial (p = 0.012). Conclusions: We identified a high prevalence of unmet needs across several supportive care domains. These areas of distress should be a targeted focus of palliative care and oncology integration to improve the care of patients with metastatic breast cancer.

The Significance of Patient-Reported Outcomes for Metastatic Breast Cancer Patients

2022 ◽  
Author(s):  
Larissa Elisabeth Hillebrand ◽  
Ulrike Söling ◽  
Norbert Marschner
Keyword(s):  
Breast Cancer ◽  
Decision Making ◽  
Metastatic Breast Cancer ◽  
Cancer Treatment ◽  
Patient Reported Outcomes ◽  
Metastatic Breast ◽  
Treatment Decision ◽  
Breast Cancer Patients ◽  
Treatment Decision Making ◽  
Patient Reported

Background: Breast cancer is still the most common malignancy in women worldwide. Once metastasized, breast cancer treatment primarily aims at reducing symptom burden, thereby trying to maintain and improve a patient´s quality of life (QoL), delaying disease progression, and prolonging survival. Curing the disease is not possible in the palliative setting. To better understand metastatic breast cancer patients, their symptoms and wishes, which are important for treatment-decision making and outcome, patient-reported outcomes (PROs) are of great importance, giving an impression of what really matters to and concerns a patient. Summary: Many advances have been made to implicate PROs in clinical trials, non-interventional studies, registries, and clinical routine care of metastatic breast cancer. For example, large phase III trials like PALOMA-3 (NCT01942135), MONALEESA-7 (NCT02278120), HER2CLIMB (NCT02614794), and KEYNOTE-119 (NCT02555657) trials implemented PROs in their trial design to assess the QoL of their trial patients. Also, non-interventional studies on metastatic breast cancer, like e.g., the NABUCCO study (IOM-02240), and prospective non-interventional, multicenter registries e.g., the tumor registry breast cancer (NCT01351584) or the breast cancer registry platform OPAL (NCT03417115), have implemented PROs to assess QoL during the anti-cancer treatment periods of the patients. Key Message: Using PROs in metastatic breast cancer can support shared treatment-decision making and management of symptoms, eventually leading to an improvement in QoL. Progressively, regulatory authorities take PROs into consideration for the approval of new drugs. Hence, the implication of PROs in cancer treatment, and especially in MBC, is of significant value.

Prioritization of Patient-Reported Outcomes by Women With Metastatic Breast Cancer

2019 ◽  
pp. 1-3
Author(s):  
Sarah S. Mougalian ◽  
Jenerius A. Aminawung ◽  
Carolyn J. Presley ◽  
Maureen E. Canavan ◽  
Margaret L. Holland ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Patient Reported Outcomes ◽  
Metastatic Breast ◽  
Patient Reported

scholarly journals PALOMA-3: Phase III Trial of Fulvestrant With or Without Palbociclib in Premenopausal and Postmenopausal Women With Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer That Progressed on Prior Endocrine Therapy—Safety and Efficacy in Asian Patients

2017 ◽  
Vol 3 (4) ◽  
pp. 289-303 ◽  
Author(s):  
Hiroji Iwata ◽  
Seock-Ah Im ◽  
Norikazu Masuda ◽  
Young-Hyuck Im ◽  
Kenichi Inoue ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Endocrine Therapy ◽  
Growth Factor Receptor ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Asian Patients ◽  
Hormone Receptor Positive ◽  
Patient Reported ◽  
Epidermal Growth

Purpose To assess efficacy and safety of palbociclib plus fulvestrant in Asians with endocrine therapy–resistant metastatic breast cancer. Patients and Methods The Palbociclib Ongoing Trials in the Management of Breast Cancer 3 (PALOMA-3) trial, a double-blind phase III study, included 521 patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative metastatic breast cancer with disease progression on endocrine therapy. Patient-reported outcomes (PROs) were assessed on study treatment and at the end of treatment. Results This preplanned subgroup analysis of the PALOMA-3 study included premenopausal and postmenopausal Asians taking palbociclib plus fulvestrant (n = 71) or placebo plus fulvestrant (n = 31). Palbociclib plus fulvestrant improved progression-free survival (PFS) compared with fulvestrant alone. Median PFS was not reached with palbociclib plus fulvestrant (95% CI, 9.2 months to not reached) but was 5.8 months with placebo plus fulvestrant (95% CI, 3.5 to 9.2 months; hazard ratio, 0.485; 95% CI, 0.270 to 0.869; P = .0065). The most common all-cause grade 3 or 4 adverse events in the palbociclib arm were neutropenia (92%) and leukopenia (29%); febrile neutropenia occurred in 4.1% of patients. Within-patient mean trough concentration comparisons across subgroups indicated similar palbociclib exposure between Asians and non-Asians. Global quality of life was maintained; no statistically significant changes from baseline were observed for patient-reported outcome scores with palbociclib plus fulvestrant. Conclusion This is the first report, to our knowledge, showing that palbociclib plus fulvestrant improves PFS in asian patients. Palbociclib plus fulvestrant was well tolerated in this study.

Can Twitter social media be an effective tool for breast cancer survivor support and education?

2014 ◽  
Vol 32 (26_suppl) ◽  
pp. 130-130
Author(s):  
Deanna J. Attai ◽  
Jeffrey Landercasper ◽  
Jody M Schoger ◽  
Alicia C Staley ◽  
Michael S Cowher
Keyword(s):  
Breast Cancer ◽  
Social Media ◽  
Metastatic Breast Cancer ◽  
Breast Imaging ◽  
Survey Methods ◽  
Metastatic Breast ◽  
The United States ◽  
Breast Cancer Patients ◽  
Cancer Support ◽  
Patient Resources

130 Background: Despite reported benefits, approximately 60% of women do not attend breast cancer support groups. Many online resources for support exist, but information regarding the effects of participation is lacking. We report the results of a Twitter breast cancer support community participant survey. Methods: The Breast Cancer Social Media (#BCSM) Twitter support community began in July 2011. IRB approval with waiver of informed consent was obtained for a de-identified survey which was posted for two weeks on Twitter and on the #BCSM blog and Facebook page. Results: There were 206 respondents, with a median age of 45-54 and 93% being female. 74% were from the United States. 92% were Caucasian. 83% completed a 4-year college degree. 69% had been treated for breast cancer. 14% reported living with metastatic breast cancer. 72% became aware of #BCSM through Twitter. 45% had been participating in the chats for > 12 months. 81% of respondents reported increased overall knowledge about breast cancer. Increased knowledge through #BCSM was reported in all the following specific domains: 86% survivorship, 80% metastatic breast cancer, 70% cancer types and biology, 66% clinical trials and research, 56% treatment options, 56% breast imaging, 54% genetic testing and risk assessment, and 43% radiotherapy. 31% reported that participation led them to seek a second opinion or bring additional information to the attention of their treatment team. 73% percent reported plans to increase their outreach and advocacy efforts as a result of participation. Levels of reported anxiety before and after participation were analyzed. 29 of 43 patients (67%) who initially reported “high or extreme” anxiety reported “low or no” anxiety after participation (p < 0.001). Also, no patients initially reporting “low or no” anxiety prior to participation reported an increase to “high or extreme anxiety” after participation. Conclusions: While many online breast cancer patient resources exist, data documenting patient educational benefits of participation are lacking. This study demonstrates that breast cancer patients’ perceived knowledge can be increased and that their anxiety can be decreased by participation in a Twitter social media support group.

Vitamin D insufficiency and risk of paclitaxel-induced peripheral neuropathy.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12027-e12027
Author(s):  
Theodore Salvatore Jennaro ◽  
Ellen M. Lavoie Smith ◽  
Kiran Vangipuram ◽  
Kelley M. Kidwell ◽  
Monika Leigh Burness ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Vitamin D ◽  
Metastatic Breast Cancer ◽  
Peripheral Neuropathy ◽  
Assessment Tool ◽  
Metastatic Breast ◽  
Vitamin D Insufficiency ◽  
Primary Analysis ◽  
Patient Reported

e12027 Background: Peripheral neuropathy (PN) is a severe, dose-limiting toxicity of paclitaxel that occurs in up to 25% of patients and can lead to permanent loss of balance and manual dexterity. Due to the lack of effective strategies for PN prevention or treatment, there is a critical need to identify predictive risk factors for paclitaxel-induced PN. Vitamin insufficiencies are known risk factors for PN in other disease states. However, the effect of vitamin insufficiency on paclitaxel-induced PN has not been adequately investigated. Methods: Baseline levels of vitamin D and other nutrients (vitamin B, homocysteine, folate) were measured, and PN was assessed weekly in an observational trial of patients receiving paclitaxel 80 mg/m2 for 12 weeks for non-metastatic breast cancer (NCT0233811). Nutrient levels were measured by Michigan Medicine and insufficiency defined by institutional standards (vitamin D insufficiency < 20 ng/mL). In the primary analysis, the maximum increase from baseline in the 8-item sensory subscale (ΔCIPN8) of the EORTC CIPN20, a validated patient-reported PN assessment tool, was compared in nutrient insufficient and sufficient patients. The effect of vitamin insufficiencies on PN-induced treatment disruptions (dose decrease, delay, or discontinuation) was conducted as a secondary analysis. Results: Only vitamin D insufficiency was identified in enough patients for analysis (15/37 = 41%). Vitamin D insufficient patients reported a greater mean (+/- SD) ΔCIPN8 (36.39 ±22.8) than vitamin D sufficient patients (16.29 ±16.3) (p = 0.003). However, the increase in treatment disruption for vitamin D insufficient patients was not significant (OR = 2.98, 95% CI [0.72, 12.34], p = 0.16). Conclusions: Paclitaxel-treated patients who were vitamin D insufficient at baseline had greater increases in patient-reported PN. If validated in larger studies, vitamin D insufficiency may be a clinically translatable, modifiable risk factor that can be used to prevent paclitaxel-induced PN in patients with non-metastatic breast cancer.

Multidisciplinary cancer teams and utilization of resources for metastatic breast cancer (MBC): A landscape analysis.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 186-186
Author(s):  
Elana Plotkin ◽  
Marianne Gandee ◽  
Lorna Lucas
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Public Funding ◽  
Metastatic Breast ◽  
Community Setting ◽  
Psychosocial Needs ◽  
Cancer Support ◽  
Cancer Support Group ◽  
Specialized Care ◽  
Online Library

186 Background: An estimated 250k Americans are currently living with MBC. While breast cancer is a high-profile disease receiving significant public funding, patients with metastatic breast cancer face unique challenges. ACCC seeks to expand the conversation to address gaps between early & metastatic disease and improve the management of MBC in the community setting. Communication challenges that cancer care teams face with MBC patients include: using a tailored and thoughtful approach, balancing hope and realism, patient engagement during conversations, incorporating principles of shared decision making, patient financial concerns, and family/caregiver involvement. Methods: An environmental scan was completed of nationally available resources. A survey on MBC Communication strategies was administered in a variety of oncology provider settings from Dec. 2018-Jan 2019. Results: Patient psychosocial needs were identified as the top challenge for working with MBC patients vs. Stage 1-3. 57% reported difficulty managing patient expectations, 55% reported patient financial concerns. While 66% of cancer programs offer a general breast cancer support group, only 27% offer a Stage 4 group. 59% of respondents rely on casual conversations with patients to assess what they want, only 34% ask patients to define what quality of life would mean for them. 33% document goals in the EMR. Over 150 free resources specific to MBC were categorized from diagnosis through hospice, resulting in a curated online library that clinicians can use with their patients. Conclusions: This patient population should be given specialized care to address their unique diagnosis and improve communications with their care team. The ACCC Resource Library gives both low and highly resourced programs access to more supportive care tailored to metastatic breast cancer.

Sign in / Sign up

Export Citation Format

Share Document