Developing a patient reported experience measure (PREM) in secondary breast cancer (SBC)

Abstract Background Cancer registries usually assess data of conventional treatments and/or patient survival. Beyond that, little is known about the influence of other predictors of treatment response related to the use of complementary therapies (CM) and lifestyle factors affecting patients’ quality and quantity of life. Methods INTREST is a prospective cohort study collecting register data at multiple German certified cancer centers, which provide individualized, integrative, in- and outpatient breast cancer care. Patient-reported outcomes and clinical cancer data of anticipated N = 715 women with pTNM stage I-III breast cancer are collected using standardized case report forms at the time of diagnosis, after completing neo−/adjuvant chemotherapy, after completing adjuvant therapy (with the exception of endocrine therapy) as well as 1, 2, 5, and 10 years after baseline. Endpoints for multivariable prediction models are quality of life, fatigue, treatment adherence, and progression-based outcomes/survival. Predictors include the study center, sociodemographic characteristics, histologic cancer and comorbidity data, performance status, stress perception, depression, anxiety, sleep quality, spirituality, social support, physical activity, diet behavior, type of conventional treatments, use of and belief in CM treatments, and participation in a clinical trial. Safety is recorded following the Common Terminology Criteria for Adverse Events. Discussion This trial is currently recruiting participants. Future analyses will allow to identify predictors of short- and long-term response to integrative breast cancer treatment in women, which, in turn, may improve cancer care as well as quality and quantity of life with cancer. Trial registration German Clinical Trial Register DRKS00014852. Retrospectively registered at July 4th, 2018.

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Comparison of the clinical effectiveness of treatments for aromatase inhibitor-induced arthralgia in breast cancer patients: a protocol for a systematic review and network meta-analysis

BMJ Open ◽

10.1136/bmjopen-2019-033461 ◽

2020 ◽

Vol 10 (5) ◽

pp. e033461

Author(s):

Kyeore Bae ◽

Si Yeon Song

Keyword(s):

Breast Cancer ◽

Systematic Review ◽

Pain Intensity ◽

Aromatase Inhibitor ◽

Cancer Patients ◽

Meta Analysis ◽

Indirect Evidence ◽

Secondary Outcome ◽

Breast Cancer Patients ◽

Patient Reported

IntroductionAromatase inhibitor-induced arthralgia (AIA) is a major adverse event of aromatase inhibitors (AIs) and leads to premature discontinuation of AI therapy in breast cancer patients. The objective of this protocol for a systematic review and network meta-analysis (NMA) is to provide the methodology to compare the change in pain intensity between different AIA treatments and demonstrate the rank probabilities for different treatments by combining all available direct and indirect evidence.Methods and analysisPubMed, the Cochrane Controlled Register of Trials (CENTRAL), EMBASE, Web of Science and ClinicalTrials.gov will be searched to identify publications in English from inception to November 2019. We will include randomised controlled trials (RCTs) assessing the effects of different treatments for AIA in postmenopausal women with stage 0–III hormone receptor-positive breast cancer. The primary endpoints will be the change in patient-reported pain intensity from baseline to post-treatment. The number of adverse events will be presented as a secondary outcome.Both pairwise meta-analysis and NMA with the Frequentist approach will be conducted. We will demonstrate summary estimates with forest plots in meta-analysis and direct and mixed evidence with a ranking of the treatments as the P-score in NMA. The revised Cochrane risk-of-bias tool for randomised trials will be used to assess the methodological quality within individual RCTs. The quality of evidence will be assessed.Ethics and disseminationAs this review does not involve individual patients, ethical approval is not required. The results of this systematic review and NMA will be published in a peer-reviewed journal. This review will provide valuable information on AIA therapeutic options for clinicians, health practitioners and breast cancer survivors.PROSPERO registration numberCRD42019136967.

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Primary tumor dependent inhibition of tumor growth, angiogenesis, and perfusion of secondary breast cancer in bone

Journal of Orthopaedic Research® ◽

10.1002/jor.21402 ◽

2011 ◽

Vol 29 (8) ◽

pp. 1251-1258 ◽

Cited By ~ 8

Author(s):

Christian Schaefer ◽

Malte Schroeder ◽

Ina Fuhrhop ◽

Lennart Viezens ◽

Jasmin Otten ◽

...

Keyword(s):

Breast Cancer ◽

Tumor Growth ◽

Primary Tumor ◽

Dependent Inhibition ◽

Inhibition Of Tumor Growth ◽

Secondary Breast Cancer

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The use of cognitive interviews to revise the Quality of Trauma Care Patient-Reported Experience Measure (QTAC-PREM)

Quality of Life Research ◽

10.1007/s11136-015-0919-5 ◽

2015 ◽

Vol 24 (8) ◽

pp. 1911-1919 ◽

Cited By ~ 4

Author(s):

Niklas Bobrovitz ◽

Maria J. Santana ◽

Theresa Kline ◽

John Kortbeek ◽

Henry T. Stelfox

Keyword(s):

Trauma Care ◽

Care Patient ◽

Cognitive Interviews ◽

Quality Of Trauma Care ◽

Patient Reported ◽

Experience Measure

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Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and Metastatic Breast Cancer Registry

Geburtshilfe und Frauenheilkunde ◽

10.1055/s-0043-116223 ◽

2017 ◽

Vol 77 (08) ◽

pp. 870-878 ◽

Cited By ~ 7

Author(s):

Markus Wallwiener ◽

Felix Heindl ◽

Sara Brucker ◽

Florin-Andrei Taran ◽

Andreas Hartkopf ◽

...

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Advanced Breast Cancer ◽

Cancer Registry ◽

Data Entry ◽

Metastatic Breast ◽

Advanced Breast ◽

Patient Reported ◽

Trial Staff ◽

Breast Cancer Registry

Abstract Purpose Patient-reported outcomes (PROs) have been incorporated into clinical trials for many symptoms and medical conditions. A transition from paper-based capture of PROs to electronic PROs (ePROs) has recently started. This study reports on the feasibility of ePRO assessment in a prospective registry including molecular data for patients with advanced breast cancer. Methods As part of the PRAEGNANT network, patients were invited by clinical trial staff, physicians, and nurses to complete three standardized Internet-based questionnaires (EQ 5D 5 L, CES-D and IPAQ). Feasibility was assessed by the staff members who assigned the user accounts by the patients. The completeness of the questionnaires was also assessed. Results Fifteen of 17 patients who were asked agreed to participate to complete the PRO questionnaires (EQ-5D-5L and CES-D). However, the IPAQ (physical activity) questionnaire was only validly completed by 9 patients. Feasibility was ranked better by the physicians and dedicated clinical trial staff than by the nursing staff. Conclusions Incorporating ePRO questionnaires into an advanced breast cancer registry is feasible, and no major hurdles were reported. Involving stakeholders from the start, the application is tailored to the capacities and abilities of both patients and clinical staff. The patientsʼ compliance was better with some questionnaires, but others may present difficulties.

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