Evaluating the impact of a trial in breast cancer tumor markers: A value of research analysis.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16524-e16524
Author(s):  
Rahber Thariani ◽  
David K Blough ◽  
William Barlow ◽  
Norah Lynn Henry ◽  
Julie Gralow ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Tumor Marker ◽  
Tumor Markers ◽  
Societal Value ◽  
Cancer Tumor ◽  
The Impact

e16524 Background: Despite not being recommended by clinical guidelines, the tumor markers carcinoembryonic antigen (CEA), cancer antigen (CA)15-3, and CA 27.29 are used by some clinicians to screen for increased risk of breast cancer recurrence. Although additional research may be warranted to evaluate the benefits and risks of breast cancer tumor marker tests, clinical trials would likely need to involve thousands of women and would take many years to complete. We conducted an analysis to assess the societal value of a prospective randomized clinical trial (RCT) for breast tumor marker testing in routine follow-up of high-risk, stage II-III breast cancer survivors Methods: We used value of information techniques to assess the benefits of reducing uncertainty of using breast cancer tumor markers. We developed a decision-analytic model of biomarker testing in addition to standard surveillance at follow-up appointments every 3-6 months for five years. Expected value of sample information (EVSI) was assessed over a range of trial sizes and assumptions. Results: The overall value of research for an RCT involving 9,000 women was $166 million (EVSI). The value of improved information characterizing the survival impact of tumor markers was $81 million, quality-of-life $38 million, and test performance $95 million. Conclusions: Our analysis indicates that substantial societal value may be gained by conducting a clinical trial evaluating the use of breast cancer tumor markers. The most important aspects of the trial in our analysis were information gained on survival improvements as well as quality-of-life parameters associated with testing and test sensitivity and specificity. Our analysis indicates that smaller randomized trials, as well as adding quality of life instruments to existing trials, retrospective, and observational trials can also generate valuable and relevant information.

How Tumor Markers are used in the Routine Follow-up of Breast and Colorectal Cancer. A Survey of 29 Italian Hospitals

1998 ◽  
Vol 13 (3) ◽  
pp. 124-138 ◽  
Author(s):  
M. Gion ◽  
P. Barioli ◽  
A. Ponti ◽  
V. Torri ◽  
R. Mione ◽  
...  
Keyword(s):  
Tumor Marker ◽  
Tumor Markers ◽  
Clinical Information ◽  
Relative Uncertainty ◽  
Hospital Beds ◽  
Wide Variability ◽  
Methodological Aspects ◽  
The Impact

The impact of tumor markers on the outcome of several malignancies is still under debate. This relative uncertainty leads to a subjective approach to their use. Monitoring the use of tumor markers is a valuable tool to identify the need for educational policies. We conducted a survey to evaluate how tumor markers are routinely used in the follow-up of patients with breast, colorectal and ovarian carcinoma. The former two malignancies are considered in the present paper. We surveyed 35 Italian hospitals; 29 (83%, accounting for 26,622 hospital beds) filled in and returned the questionnaire. Overall, 467,361 tumor marker requests were scrutinized by the surveyed hospitals. We found a wide variability in the type and number of routinely used markers, the cutoff points chosen, and the clinical decisions taken on the basis of marker results. In addition, we observed a relative lack of communication between clinicians and clinical pathologists in around 50% of the surveyed hospitals. In these cases clinical information was not provided to the laboratory and methodological aspects were not communicated to clinicians. From the findings of the present study we conclude that the cooperation between clinicians and clinical pathologists must improve before guidelines for the use of tumor marker assays can be framed and the compliance with these guidelines can be checked. Request forms for tumor marker assays should therefore be designed to contain clinical information and the quality of filling in request forms with clinical data should be carefully monitored.

scholarly journals Protocol for the BRECAR study: a prospective cohort follow-up on the impact of breast reconstruction timing on health-related quality of life in women with breast cancer

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e018108 ◽  
Author(s):  
Maria Herrera de la Muela ◽  
Enrique García López ◽  
Laura Frías Aldeguer ◽  
Paloma Gómez-Campelo
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Psychological Impact ◽  
Health Related Quality ◽  
La Paz ◽  
Related Quality ◽  
Health Related ◽  
The Impact

IntroductionThe completion of postmastectomy breast reconstruction (BR) in women with breast cancer can last from months to years, and to our knowledge, there is a lack of studies that analyse how the different types and times of reconstruction impact on the patient’s quality of life and psychosocial adjustment.The primary aim of the BREast Cancer Reconstruction (BRECAR Study) is twofold. First, to describe health-related quality of life (HRQoL), overall satisfaction with surgery and psychological impact (body image, self-esteem, depression and anxiety) on women who will have undergone a mastectomy with planned BR, considering the varied timing of BR procedures (immediate BR (iBR), delayed BR (dBR) and two-stage BR (2sBR)). To measure the impact on surgical outcomes, we will obtain data prior to and after surgery (6–9 and at 18 months of follow-up). Second, to analyse sociodemographic, clinical and psychosocial factors associated with HRQoL, satisfaction with surgery and psychological impact.Methods and analysisA prospective, observational, clinical cohort study of women diagnosed with breast cancer who have an indication for mastectomy treated at La Paz University Hospital (Madrid, Spain).Patients will be classified into one of three groups under conditions of routine clinical practice, based on the type of BR planned: the iBR group, the dBR group and the 2sBR group.Under typical clinical practice conditions, we will perform three visits: baseline visit (presurgery), V1 (6–9 months after diagnosis) and V2 (18 months after diagnosis). A sample size of 210 patients is estimated.Ethics and disseminationThe study protocol and informed consent form have been reviewed and approved by the Institutional Review Board of La Paz Hospital (no. PI-2036). Dissemination of results will be via journal articles and conference presentations.

scholarly journals Evaluate the Impact of Breast Cancer Treatment on the Quality of Life of Women With Nonmetastatic Breast Cancer

2018 ◽  
Vol 4 (Supplement 2) ◽  
pp. 99s-99s
Author(s):  
H. Aouras ◽  
Sabiha Bouzbid
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Hormonal Therapy ◽  
Medical Decision ◽  
Clinical Phase ◽  
Social Difficulties ◽  
Socio Demographic Factors ◽  
The Impact

Background: The quality of life related to health has become an important part of the medical decision at the same time as the effectiveness and safety of treatments. Clinicians should consider the quality of life of women at each clinical phase of the care trajectory. Indeed, the physical, functional, psychological, and social difficulties that women live may affect their quality of life, hence the need to assess it. Aim: To evaluate the quality of life of women with breast cancer using a previously validated tool. Methods: This is a prospective cohort study with a longitudinal follow-up of patients treated and followed for breast cancer at the Gynecology Department of EHS El Bouni and medical oncology service, over a period of one year from April 1, 2013 until March 31, 2014. 196 patients were selected for the study according to specific inclusion criteria. Both questionnaires QLQC30/BR23 were informed after diagnosis (T1), after surgery and about a month after the end of chemotherapy (T2), and one month after the end of radiotherapy and the beginning of hormonal therapy (T3). Results: ANOVA analysis shows that the quality of life related to the health of women with breast cancer changes over time, overall, it is worse during the time 2 “treatment period” including chemotherapy. The alteration scores are concerned with both generic and specific functional dimensions. The same happens at the level of symptoms where we note an increase in different symptoms during the treatment. During time 3, women have a better score for “emotional” “role” functioning and overall health; they have fewer side effects and symptoms for radiotherapy and follow-up. We observe a decrease in sexual functioning during the diagnosis; it then slightly improves after the end of chemotherapy and decreases during hormonal therapy. Regarding the socio-demographic factors, we have found a significant association on the one hand, between the age of the patient and the importance of “body image” in the quality of life, and on the other hand, between the socio-economic level and the symptoms in the breast. Conclusion: This study emphasizes the importance of evaluating longitudinally the quality of life related to the health of women with breast cancer at different times of the care trajectory, particularly during chemotherapy and radiotherapy. Thus, better psychosocial resources can be developed to help these groups of women.

scholarly journals Pens versus syringes to deliver insulin among elderly patients with type 2 diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Rafael Vaz Machry ◽  
Gustavo Fonseca Cipriani ◽  
Henrique Umpierre Pedroso ◽  
Rafaela Ramos Nunes ◽  
Thayme Luisa Souza Pires ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Glycemic Control ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registration ◽  
Bolus Insulin ◽  
The Impact

Abstract Background Diabetes mellitus (DM) is a prevalent disease among elderly population. As the disease progresses, insulin may become necessary. The use of pens application seems to be more practical. However, the influence of this method on glycemic control needs to be defined in elderly people. Methods Randomized clinical trial comparing pens and syringes for insulin application among patients with type 2 DM over 60 years old and Glycated Hemoglobin > 8.5% at baseline. The follow-up was 24 weeks, with monthly medical visits to adjust the treatment. All patients received insulin NPH and, if necessary, insulin Regular. We assessed glycemic control, adherence to treatment, hypoglycemia occurrence, need for adjustment in treatment and impact on quality of life, Results We included 121 patients with mean age of 65.75 years. Sixty-one were randomized for pen group (PG) and 60 patients for syringe group (SG). At baseline, mean HbA1c was 10.34 ± 1.66% and 9.90 ± 1.25% (p = 0.103) in PG and SG respectively. Mean HbA1c was 8.39 ± 1.28% in PG and 8.85 ± 1.74% in SG (p = 0.101) at 24 weeks. However, there was a more significant reduction in PG (− 1.94 ± 1.93% in PG and − 1.04 ± 1.46% in SG, p < 0.05) during follow-up. We found no difference in treatment adherence rates, hypoglycemia, greater need for insulin doses or oral medication, and progression to basal-bolus insulin scheme. We also found no difference in the impact of the disease on quality of life between groups. Conclusion Although we did not find any difference in the impact on quality of life, frequency of hypoglycemia or adherence, the PG showed a reduction in HbA1c higher in 24 weeks of follow-up. Clinical trial registration: NCT02517242

The effect of surgery in tenosynovial giant cell tumours as measured by patient-reported outcomes on quality of life and joint function

2019 ◽  
Vol 101-B (3) ◽  
pp. 272-280 ◽  
Author(s):  
F. G. M. Verspoor ◽  
M. J. L. Mastboom ◽  
G. Hannink ◽  
W. T. A. van der Graaf ◽  
M. A. J. van de Sande ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Giant Cell ◽  
Diffuse Type ◽  
Joint Function ◽  
Population Means ◽  
Sf 36 ◽  
Patient Reported ◽  
The Impact

Aims The aim of this study was to evaluate health-related quality of life (HRQoL) and joint function in tenosynovial giant cell tumour (TGCT) patients before and after surgical treatment. Patients and Methods This prospective cohort study run in two Dutch referral centres assessed patient-reported outcome measures (PROMs; 36-Item Short-Form Health Survey (SF-36), visual analogue scale (VAS) for pain, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)) in 359 consecutive patients with localized- and diffuse-type TGCT of large joints. Patients with recurrent disease (n = 121) and a wait-and-see policy (n = 32) were excluded. Collected data were analyzed at specified time intervals preoperatively (baseline) and/or postoperatively up to five years. Results A total of 206 TGCT patients, 108 localized- and 98 diffuse-type, were analyzed. Median age at diagnosis of localized- and diffuse-type was 41 years (interquartile range (IQR) 29 to 49) and 37 years (IQR 27 to 47), respectively. SF-36 analyses showed statistically significant and clinically relevant deteriorated preoperative and immediate postoperative scores compared with general Dutch population means, depending on subscale and TGCT subtype. After three to six months of follow-up, these scores improved to general population means and continued to be fairly stable over the following years. VAS scores, for both subtypes, showed no statistically significant or clinically relevant differences pre- or postoperatively. In diffuse-type patients, the improvement in median WOMAC score was statistically significant and clinically relevant preoperatively versus six to 24 months postoperatively, and remained up to five years’ follow-up. Conclusion Patients with TGCT report a better HRQoL and joint function after surgery. Pain scores, which vary hugely between patients and in patients over time, did not improve. A disease-specific PROM would help to decipher the impact of TGCT on patients’ daily life and functioning in more detail. Cite this article: Bone Joint J 2019;101-B:272–280.

scholarly journals The impact of lymphedema on health-related quality of life up to 10 years after breast cancer treatment

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Mads G. Jørgensen ◽  
Navid M. Toyserkani ◽  
Frederik G. Hansen ◽  
Anette Bygum ◽  
Jens A. Sørensen
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cancer Treatment ◽  
Breast Cancer Treatment ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
The Impact

AbstractThe impact of breast cancer-related lymphedema (BCRL) on long-term quality of life is unknown. The aim of this study was to investigate the impact of BCRL on health-related quality of life (HRQoL) up to 10 years after breast cancer treatment. This regional population-based study enrolled patients treated for breast cancer with axillary lymph node dissection between January 1st 2007 and December 31th 2017. Follow up and assessments of the included patients were conducted between January 2019 and May 2020. The study outcome was HRQoL, evaluated with the Lymphedema Functioning, Disability and Health Questionnaire, the Disabilities of the Arm, Shoulder and Hand Questionnaire and the Short Form (36) Health Survey Questionnaire. Multivariate linear logistic regression models adjusted for confounders provided mean score differences (MDs) with 95% confidence intervals in each HRQoL scale and item. This study enrolled 244 patients with BCRL and 823 patients without BCRL. Patients with BCRL had significantly poorer HRQoL than patients without BCRL in 16 out of 18 HRQoL subscales, for example, in physical function (MDs 27, 95%CI: 24; 30), mental health (MDs 24, 95%CI: 21; 27) and social role functioning (MDs 20, 95%CI: 17; 23). Age, BMI, BCRL severity, hand and dominant arm affection had only minor impact on HRQoL (MDs < 5), suggesting a high degree of inter-individual variation in coping with lymphedema. This study showed that BCRL is associated with long-term impairments in HRQoL, especially affecting the physical and psychosocial domains. Surprisingly, BCRL diagnosis rather than clinical severity drove the largest impairments in HRQoL.

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