scholarly journals Electronic-Based Patient-Reported Outcomes: Willingness, Needs, and Barriers in Adjuvant and Metastatic Breast Cancer Patients

JMIR Cancer ◽  
2017 ◽  
Vol 3 (2) ◽  
pp. e11 ◽  
Author(s):  
Andreas D Hartkopf ◽  
Joachim Graf ◽  
Elisabeth Simoes ◽  
Lucia Keilmann ◽  
Nina Sickenberger ◽  
...  
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.


Author(s):  
Takuya Kawahara ◽  
Naruto Taira ◽  
Takeru Shiroiwa ◽  
Yasuhiro Hagiwara ◽  
Takashi Fukuda ◽  
...  

Abstract Purpose To establish minimal important differences (MIDs) for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30) in patients with metastatic breast cancer. Methods The dataset was obtained from the SELECT BC-CONFIRM randomized clinical trial. Anchors obtained from patients (transition items) and clinicians (performance status) were used for anchor-based methods. Anchors obtained through 6 months after starting treatment were used for this analysis. Correlation coefficients of anchor and change in QLQ-C30 and effect size were used to qualify for estimating MIDs. Mean change method and generalized estimating equation were applied to estimate MIDs. Distribution-based methods were used for comparison. Results We analyzed a dataset of 154 metastatic breast cancer patients. MIDs were estimated in 8 of 15 scales of QLQ-C30. Estimated MIDs for within-group improvement varied from 7 to 15 and those for deterioration varied from − 7 to − 17. Estimated MIDs for between-group improvement varied from 5 to 11 and those for deterioration varied from − 5 to − 8 across QLQ-C30 scales. Patient-reported anchors were more susceptible to early changes in health status than clinician-reported anchors. Conclusion We provided the MIDs of the QLQ-C30 using both patient- and clinicians-reported anchors measured in a randomized trial of Japanese patients with metastatic breast cancer. We recommend patient-reported anchors for anchor-based estimation of MID. Our results can aid patients and clinicians, as well as researchers, in the interpretation of QLQ-C30.


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