Patient-reported outcomes to assess symptoms in patients with metastatic breast cancer: Pilot implementation project.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 177-177
Author(s):  
Shruti Sinkar ◽  
Faith Too ◽  
Kelly Carr ◽  
Jessica Jelinek ◽  
Elizabeth Saylor ◽  
...  

177 Background: Use of patient-reported outcomes (PRO) to evaluate symptoms improves clinical outcomes. Best practices for implementing PROs into routine care may vary according to clinical scenario, site-specific resources and programmatic goals. Patients with metastatic breast cancer (MBC) often experience a variety of symptoms. Methods: As a quality improvement project, we are pilot testing incorporation of a battery of PRO measures into routine care for patients with MBC at Johns Hopkins in order to gain experience that will guide future broader implementation of PROs across our program. Participants complete the PROs on paper at baseline (BL), 3, and 6 months (mo). Measures include NCCN Distress Thermometer (BL only), Patient Health Questionnaire-8 (PHQ-8), Generalized Anxiety Disorder-7 (GAD-7), PRO-CTCAE Insomnia questions and a modified version of the revised Edmonton Symptom Assessment System (r-ESAS) questionnaire with 3 extra symptom domains. Project team members alert clinicians by email of scores that exceed severity thresholds as follows – Distress: ≥4, PHQ-8: ≥8, GAD-7: ≥10, any item on r-ESAS: ≥4 and PRO-CTCAE Insomnia: severe/very severe or quite a bit/very much. Results: From May 29, 2020 and April 5, 2021, 67 patients were approached for participation, and 40 (59.7%) completed the BL PROs. Median age was 64 (range 36-85). Most participants were White (70%), non-Hispanic (90%) and had hormone receptor-positive (93%) MBC. At BL, 22 (55%) had visceral disease and most were receiving endocrine-based regimens [21 (53%)] or chemotherapy [16 (40%)]. 27 (68%) participants had ≥1 BL alert. The most common BL alerts were for symptoms on the r-ESAS [23 participants (58%)]. The most frequent items on the r-ESAS for which participants had BL alerts were pain, tiredness, well-being, tingling/numbness and rash. Other BL alerts were: Distress [9 participants (23%)], PRO-CTCAE Insomnia [5 participants (13%)], PHQ-8 [4 participants (10%)] and GAD-7 [2 participants (5%)]. To date, 24 of 35 (69%) and 15 of 28 (54%) participants who have reached the 3 and 6 mo time points have completed the respective follow-up (FU) PROs. Most common FU alerts to date are on the r-ESAS [3 mo: 14 participants (58%), 6 mo: 9 participants (60%)]. The project team has successfully notified providers of all alerts to date. Clinical actions (phone calls, provider visits and/or referrals) have been taken within 30 days of notification for > 75% of alerts. Conclusions: Implementation of a PRO battery for patients receiving routine care for MBC led to detection of a range of symptoms, the majority of which were clinically actionable. Restrictions on in-person interactions during the COVID-19 pandemic may have contributed to low rates of PRO completion in this pilot project. Prior to broader implementation, we will consider strategies such as an electronic platform and a shorter battery to enhance patient engagement.

Author(s):  
Larissa Elisabeth Hillebrand ◽  
Ulrike Söling ◽  
Norbert Marschner

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.


2019 ◽  
pp. 1-3
Author(s):  
Sarah S. Mougalian ◽  
Jenerius A. Aminawung ◽  
Carolyn J. Presley ◽  
Maureen E. Canavan ◽  
Margaret L. Holland ◽  
...  

2016 ◽  
Vol 25 (2) ◽  
pp. 549-558 ◽  
Author(s):  
Stefan Stefanovic ◽  
Markus Wallwiener ◽  
Uros Karic ◽  
Christoph Domschke ◽  
Luka Katic ◽  
...  

2017 ◽  
Vol 35 (5_suppl) ◽  
pp. 228-228
Author(s):  
Maira Caleffi ◽  
Norah Ana Burchardt ◽  
Helio Pasqualotto Scapin ◽  
Isabel Crivelatti ◽  
Carlos Spode Gomes ◽  
...  

228 Background: Breast cancer is still a leading cause of death and suffering worldwide. To date, metastatic breast cancer (MBC) is a treatable but incurable disease. Molecular subtypes influence outcomes, with recent increase in median overall survival to 56 months in HER2+ disease (Swain et al NEJM 2015). The success of MBC treatment underscores the increasing importance of discussing quality of life (QoL) and patients’ needs. A survey evaluating patient-reported outcomes was carried out in a Brazilian center with the aim of evaluating patient’s QoL, needs and expectations. Methods: In this IRB approved study, MBC patients were selected from clinical database for phone interviews. During the call, verbal consent was obtained and recorded. Patients answered a standardized questionnaire containing 28 questions about their experience with MBC. RedCap database was created with data from interviews for further analysis. Results: A total of 94 patients with MBC were initially screened. From these, 50 were interviewed (24 deceased, 6 declined and 14 had technical problems). Patient’s age ranged from 31-87y. In 44% family income decreased after MBC diagnosis. Median time from diagnosis of MBC to interview was 62 months (range 1-274 months). Most patients (86%) kept themselves informed about MBC; main sources being doctors (100%), internet (76%), media (71%), other patients (54%), and family (48%). Only 6% didn’t know what MBC meant. Majority were on therapy: chemotherapy/injectables (54%), oral medication (36%), and radiation (2%). Most (86%) preferred follow up by a multidisciplinary team, and 18% would prefer exclusive MBC clinics. Only 6% accepted the label “metastatic”. Less popular labels were “advanced disease” (6%), “recurred” (4%), “palliative” (4%), or “disseminated” (0%). They preferred this disease phase be called “controlled disease” (50%) or “chronic disease” (28%). Conclusions: The main sources of information about MBC for patients are the internet and their providers. In this center, communication between providers, policy makers and MBC patients could potentially be improved with terminology changes, since patients would prefer the metastatic phase of their disease be called “Controlled Disease”.


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