Engaging patients and stakeholders in the process of designing a clinical trial and patient education platform.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 63-63
Author(s):  
Lauren M. Rosati ◽  
Sarah Douglas ◽  
Roger Leventer ◽  
Laurie Singer Sievers ◽  
Randall W. Swan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Patient Education ◽  
Study Design ◽  
Patient Engagement ◽  
Performance Status ◽  
Poor Performance Status ◽  
Initial Survey ◽  
Education Platform ◽  
Study Participants

63 Background: Patient engagement during the initiation, development, and implementation of a study has been shown to improve the ethical nature of research and the appropriateness of treatment methods, and insights into how best to partner with patients are needed. We describe our patient engagement experience in developing a clinical trial for non-metastatic pancreatic cancer (PCA). Methods: A team of patient research partners (PRPs) was consulted to design a multi-institutional study to evaluate the efficacy of chemotherapy, stereotactic body radiation therapy, and early palliative care (EPC) in patients with PCA who are typically ineligible for clinical trials due to advanced age, poor performance status, or preexisting comorbidities. PRPs included patients, caregivers, clinical researchers, patient advocacy organizations, and pharmaceutical companies. A 22-item initial survey on personal interests and a 5-item follow-up survey on study design were anonymously completed after two in-person meetings. Results: Of 15 PRPs involved, 9 completed the initial survey and 10 completed the follow-up survey. PRPs were most interested in improving quality of life (QOL, 89%), care coordination (78%), symptom management (67%), stress/anxiety (56%), and survival (56%). Confidence in the care team, hope, QOL, education and understanding, dignity, and pain management were reported to be the most important factors throughout the cancer experience. The majority (89%) requested that study participants have access to the study protocol and research publications supporting the study design. Because all PRPs suggested that a personal website be used to provide information to study participants and to disseminate the results of the study, an online patient education platform was adopted and customized for patients (and caregivers). Furthermore, integration of EPC into the treatment regimen was unanimously endorsed. Conclusions: Engaging PRPs in the process of designing a clinical trial for PCA appears to be feasible and valuable in identifying the study objectives most important to patients. PRPs conveyed that maintaining a good QOL is essential, and adoption of EPC in these patients should be considered.

Palliative electrochemotherapy in primary or recurrent vulvar cancer

2020 ◽  
Vol 30 (7) ◽  
pp. 927-931 ◽  
Author(s):  
Giacomo Corrado ◽  
Giuseppe Cutillo ◽  
Simona Maria Fragomeni ◽  
Valentina Bruno ◽  
Luca Tagliaferri ◽  
...  
Keyword(s):  
Palliative Treatment ◽  
Pulse Generator ◽  
Vulvar Cancer ◽  
Response Rate ◽  
Performance Status ◽  
Poor Performance ◽  
Median Number ◽  
Poor Performance Status ◽  
Electrical Pulses

ObjectiveSince vulvar cancer is such a rare disease, the international experience with electrochemotherapy has been derived from only a few centers. The aim of this study was to evaluate clinical outcome and side effects profile with the use of electrochemotherapy in patients with primary or recurrent vulvar cancer.MethodsData were retrospectively collected from November 2017 to November 2019 in two major Italian oncologic institutes: Regina Elena Institute and Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Electrochemotherapy was offered in a palliative setting to patients with a primary or recurrent vulvar cancer who were not candidates for surgery or any other treatment, because of poor performance status or previous delivered treatments. All patients underwent general anesthesia. Electrical pulses were delivered using a pulse generator. Intravenous bleomycin was administered in conjunction with electrochemotherapy. Follow-up examinations were performed at 1, 3, and 6 months. Primary endpoint was to assess the response rate of electrochemotherapy as palliative treatment in patients with vulvar cancer.ResultsA total of 15 patients were included in the study. Fourteen patients (93.3%) had a squamous cell carcinoma and one patient had vulvar carcinosarcoma. Ten patients (66.7 %) had a single lesion and 5 patients (33.3%) had multiple lesions. Median number of electrical pulses was 22 (range 3–42) and median operative time was 13 (range 7–20) min. No intra-procedure complications occurred. One patient had pneumonia during their post-operative stay. Overall response rate after 1 month was 80%. At the 3-month follow-up, 3 patients (20%) had disease progression, 3 patients (20%) had died from ongoing disease, 1 patient (6.7%) died for other reasons, whereas the other patients maintained their 1-month clinical response. A total of 8/13 patients (61.5%) were alive at 6-month follow-up, whereas 6/12 patients (50%) were alive at 1-year follow-up.ConclusionsElectrochemotherapy is a feasible, easy to perform, and reproducible procedure in patients with primary or recurrent vulvar cancer who are unable to undergo surgery. Survival after 1 year in this population was 50%. Electrochemotherapy may have a role in the management of vulvar cancer, especially as palliative treatment when other therapies are no longer applicable.

153Sm-EDTMP and 177Lu-EDTMP are equally safe and effective in pain palliation from skeletal metastases

2018 ◽  
Vol 57 (05) ◽  
pp. 174-180 ◽  
Author(s):  
Mehrdad Taheri ◽  
Zahra Azizmohammadi ◽  
Mojtaba Ansari ◽  
Payman Dadkhah ◽  
Kasra Dehghan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pain Intensity ◽  
Functional Status ◽  
Phosphonic Acid ◽  
Performance Status ◽  
Ethylene Diamine ◽  
Skeletal Metastases ◽  
Ecog Performance Status ◽  
Double Blind

Summary Introduction: Bone pain from multifocal blastic or mixed lytic-blastic metastatic lesions can be effectively addressed with radiopharmaceuticals with high affinity for such foci. 153Sm-ethylene diamine tetramethylene phosphonic acid (153Sm-EDTMP) and 177Lu-ethylene diamine tetramethylene phosphonic acid) (177Lu-EDTMP) are two such radiopharmaceuticals. The aim of this study was to make a comparison of efficacy between 153Sm-EDTMP and 177Lu-EDTMP in terms of palliation of commonly encountered symptoms in cancer patients, functional status, and pain intensity as measured by Edmonton Symptom Assessment System (ESAS), Eastern Cooperative Oncology Group (ECOG) performance status, and numeric rating scale (NRS) respectively. This study was a double blind randomized clinical trial conducted in a setting of three university hospitals. Materials and Methods: In a randomized double-blind clinical trial 50 patients will with documented painful bone metastases of blastic or mixed lytic-blastic nature were randomly allocated into two groups; group receiving 153Sm-EDTMP and group receiving 177Lu-EDTMP. Radiopharmaceuticals were given at a dose of 37.0 MBq / kg body weight in both groups. Scores on ESAS, ECOG performance status and NRS were recorded before the intervention and following the intervention at 2, 4, 6, and 12 weeks. Hematologic toxicity was evaluated by monitoring hematologic parameters at the baseline and at 1, 3, 6, and 8 weeks after the intervention.Results: Fifty patients, 31 (62 %) females and 19 (38 %) males with the mean age of 66.08 ± 4.53 years were recruited. The baseline means and standard deviations for pain intensity as measured by the NRS were 8.4 ± 1.47 and 8.36 ± 1.43 in 153Sm-EDTMP- and 177Lu-EDTMP-treated subjects respectively. Patients of both groups showed significant alleviation of pain observed from the 2nd week (first follow up session) and continuing to the 12th week after treatment . No difference in response to the two radiopharmaceuticals were seen regarding their efficacy in pain alleviation (P < 1.0). Baseline “symptom distress scores” drawn from the ESAS-r in 153Sm-EDTMP- and 177Lu-EDTMP-treated groups were 5.5 ± 2.1 and 5.4 ± 2.1, respectively. The scores significantly improved in both groups with the most marked rate of improvement achieved within the first two weeks after treatment. The scores continued to improve until the 12th week of follow-up (P < 1.0, non-significant [ns]). Functional status as measured by ECOG performance status scores improved in both groups over the follow up period. Baseline scores on ECOG performance status in 153Sm-EDTMP- and 177Lu-EDTMP-treated groups were 2.5 ± 1.3 and 2.5 ± 1.3 (mean ± standard deviation). At 3 months post-treatment scores improved to 1.6 ± 0.6 and 1.6 ± 0.6 respectively (P < 1.0, n.s.). Conclusions: 153Sm-EDTMP and 177Lu-EDTMP are safe and effective radiopharmaceuticals in palliation of cancer pain from multiple skeletal metastases of blastic and mixed lyticblastic nature.

scholarly journals Rationale and study-design of a randomized, placebo-controlled, double-blind phase 2b trial to Evaluate Efficacy, Safety and Tolerability of an oral glutaminyl cyclase inhibitor Varoglutamstat (PQ912) in Study participants With MCI and Mild AD -  VIVIAD

2021 ◽  
Author(s):  
E.G.B. Vijverberg ◽  
T.M. Axelsen ◽  
A.R. Bihlet ◽  
K. Henriksen ◽  
F. Weber ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Small Molecule ◽  
Study Design ◽  
State Of The Art ◽  
Brain Activity ◽  
Double Blind ◽  
Glutaminyl Cyclase ◽  
Disease Characteristics ◽  
Study Participants

Abstract Background: Varoglutamstat (formerly PQ912) is a small molecule that inhibits the activity of the glutaminyl cyclase to reduce the level of pyroglutamate-A-beta (pGluAB42). Recent studies confirm that pGluAB42 is a particular amyloid form that is highly synaptotoxic and plays a significant role in the development of AD. Methods:This paper describes the design and methodology behind the VIVIAD-trial. The aim of this study is to evaluate varoglutamstat in a state-of-the-art phase 2b, placebo-controlled, double-blind, randomized clinical trial on safety and tolerability, efficacy on cognition, brain activity and AD biomarkers. In addition to its main purpose, the trial will explore potential associations between novel and established biomarkers and their individual and composite relation to disease characteristics. Results: to be expected early 2023Conclusion: This state of the art phase 2b study will yield important results for the field and the treatment of AD with a small molecule directed against pyroglutamate-A-beta.

scholarly journals CLINICAL EFFICACY OF ARDHAMATRIKA BASTI IN GRIDHRASI

2022 ◽  
Vol 12 (6) ◽  
pp. 50-55
Author(s):  
Aiyanna PP ◽  
Vishnu Prasad V ◽  
Pradeep JM
Keyword(s):  
Clinical Trial ◽  
Sample Size ◽  
Clinical Efficacy ◽  
Study Design ◽  
Marked Improvement ◽  
Selection Criteria ◽  
Assessment Criteria ◽  
Treatment Modalities ◽  
Practical Utility

Gridhrasi, one among the Nanatmaja Vikara, specific Nidana and Samprapti is not explained in classics so that the general Vata Vyadi Nidhana Samprapthi can be considered. The Chikitsa of Gridhrasi includes Sneha, Sweda, Bastikarma and Agni karma. Generally, Basti is the best line of treatment for Vata dosa. References from Acharya Charaka also explain Basti as one of the treatment modalities. With the support of Niruhadikara in Chakradhatta, we have the reference of Ardhamatrika Basti, which is one among Kashaya Basti, here he explains the practical utility along with many added benefits of Bala, Varna, Vrushatha and Pumsavanathva which gifted by Atreya Maharshi. Ardhamatrika Basti, one among Madhutailika Basti (having an equal quantity of Madhu and Taila), can be clinically explored where neither Parihara Kala nor Purva karma like Sneha, Sweda are necessary. The study design selected for the study was a comprehensive clinical trial. The sample size for the present study was 30 patients suffering from Gridrasi as per the selection criteria. Patients were randomly selected irrespective of sex and were treated with Ardhmatrika Basti as a yoga Basti for eight days. Among 30 patients taken for study, marked improvement in the symptomatology of the disease is obtained. 26.7% of patients got complete Shamana, 36.7% achieved Prayika shamana, 30% reported Amsika shamana, and 6.6% had Kinchit shamana. In the assessment criteria taken in patients, Ruja BT - 2.68 after follow up reduced to 1.8, Spandana BT - 2.38 after follow up reduced to 1.73, Sakthana Utksepa-nigraha BT - 2.82 after follow up reduced to 1.58, Gourava BT - 2.5 after follow up reduced to 1.7, Arochaka BT - 2.22 after follow up reduced to 1.87. This result shows that the present study of Ardhamatrika Basti has given a marked improvement in treating Gridhrasi.

scholarly journals Multiple Myeloma Therapy in Tawam Hospital. First Report from United Arab Emirates (UAE)

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5652-5652
Author(s):  
Arif Alam ◽  
Khaled al Qawasmeh ◽  
Maria Aamir ◽  
Philip L. McCarthy
Keyword(s):  
Plasma Cell ◽  
Induction Therapy ◽  
Response Rate ◽  
Performance Status ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Cell Leukemia ◽  
Plasma Cell Disorders ◽  
Lost To Follow Up

Abstract Introduction: Plasma cell disorders are a heterogeneous group of disease ranging from Monocloncal gammopathy of unknown significance to Multiple myeloma (MM) and the highly lethal plasma cell leukemia. The prognosis and therapy of MM has been revolutionized in the past two decades with the introduction of proteasome inhibitors, immunomodulatory drugs (IMiDs) and the monoclonal antibodies. The standard of care for induction has been become a triplet regimen lately. Here we describe our experience with the management of MM patients. Methods: This is a retrospective analysis of Thirty-five patients who were seen with diagnosis with plasma cell disorders from January 1, 2016 till June 30th 2018 at our center in the UAE. Patients with solitary plasmacytoma and plasma cell leukemia were excluded from further analysis (N=3). Thirty-two patients were included in the analysis. Results: The median age was 58 years (range 26 to 94 years). Male to female ratio was 3:1. Biochemical classification showed ten patients with light chain disease only. Twelve patients had IgG kappa disease, eight had IgG lambda while there was one with IgA lambda disease and one was non-secretory with diffuse plasmacytomas. ISS staging (based on albumin and Beta 2 microglobulin) showed ISS stage 1=7, ISS stage 2= 13, ISS stage 3=8 and data was not available for four patients (diagnosed elsewhere). Cytogenetic risk stratification was not possible due to lack of access to interphase FISH. Seven patients did not receive any therapy either due to refusal for further investigation and therapy or poor performance status and comorbidities. Four of these seven have expired while the other three have been lost to follow-up. Twenty-four patients were given induction therapy with a Bortezomib (V)-based regimen while one received IMIDs-based treatment. Regimens and patient numbers are as follows: RVd (Lenalidomide/V/dexamethasone) (N=16), PVd (pomalidomide instead of R due to renal insufficiency) (N=1), V/thalidomide (T) (N=1), VCd (N=2; one for secondary amyloidosis) and Vd (N=4) (poor performance status and/or comorbidities). All patients were given zoledronic acid as well as herpes zoster prophylaxis. Venous thromboembolism (VTE) prophylaxis was prescribed based on published guidelines. Response evaluation was performed in patients receiving at least four cycles of therapy: CR(N=7); Very Good Partial Remission (VGPR) (N=6); Partial Response (PR) (N=5) and not evaluable for response due to lack of data (N=7). Five patients were documented to have received autologous stem cell transplant (autoSCT). Seven patients, lost to follow up after induction presumably received an autoSCT. Conclusion: This is the first report on the management of MM patients in UAE. With a median follow-up of 216 days (range 3 to 839 days) the response rate to induction therapy was 72% (CR+ VGPR). We are unable to report progression free survival due to short follow-up. This response rate of 72% (VGPR or better) is less than the reported in the literature. This may partly be due to lack of patient data regarding induction therapy elsewhere, the use of double over triplet regimens and the absence of autoSCT facilities. Outcome measurement is a difficult task due to tendency of local citizens to travel outside UAE for treatment and the transient nature of the large expatriate population (88% of the total population of approximately 5.4 million) We are working on developing an infrastructure for consistent testing (CD138-selected FISH, consistent staging, use of PET-CT and bone marrow MRI as well as developing auto SCT facilities). We have formulated a uniform treatment plan based on weekly RVd based therapy for 16 weeks as induction followed by recommendation for Auto SCT. If auto SCT is not possible then patients will continue RVd therapy for a total of 12 cycles followed by maintenance lenalidomide till progression. The standardization of diagnosis, therapeutic approach and follow-up should optimize the care and outcomes of UAE MM patients. Disclosures McCarthy: Bristol Myers Squibb: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Karyopharm: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; Janssen: Consultancy, Honoraria.

Frequency of Allogeneic Stem Cell Transplant(SCT) in Patients Presenting with Newly-Diagnosed AML or AML at Time of First Salvage Therapy.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4332-4332
Author(s):  
Ravinder Sandhu ◽  
Stephen Petersdorf ◽  
Brenda M. Sandmaier ◽  
Paul O'Donnell ◽  
Pamela S. Becker ◽  
...  
Keyword(s):  
Salvage Therapy ◽  
Conflicts Of Interest ◽  
Performance Status ◽  
Age Distribution ◽  
Poor Performance ◽  
Initial Therapy ◽  
Poor Performance Status ◽  
Cell Transplant ◽  
Newly Diagnosed

Abstract Abstract 4332 Allogeneic SCT is widely considered the therapy most likely to prolong survival in pts with AML in first CR(CR1) or relapse (REL). Questions have arisen regarding the frequency with which the procedure is undertaken in a defined population of pts presenting with newly-diagnosed AML and subsequently followed through REL and after, or in pts presenting in REL. We first analyzed 26 consecutive UW pts age < 70 who did not have CBF AML, who were not NPM1+/FLT3,- and who achieved CR1 with at least 4 months have elapsing from presentation date. These patients would typically be considered candidates for SCT in CR1 Eleven of the 26(42%, 95% CI 23-63%) received SCT at a median of 3.5 months (range 0.5-9.0) from CR date. Rates of SCT were 42% both in pts age <60(8/19) and in pts ≥ 60 (3/ 7). In contrast to a report from another institute in which 14/99 pts age ≥50 received SCT in CR1 7/16 of the current pts did so (p=0.01). Rates of SCT were 6/13 in pts at highest risk based on cytogenetics and FLT3 status and 3/11 in pts at lower (i.e. “intermediate” risk; risk status not known in 2) Three of the 15 pts who did not receive SCT had available donors, but 12 were not HLA –typed. Age distribution was similar (p=0.31) in pts who were and were not HLA-typed and in only 2 non-typed pts were financial considerations or pt refusal an issue. Rather, notes suggested that physicians felt that pts were doing well and might not need SCT. We also examined our 21 consecutive pts who were under age 70, did not receive SCT in CR1, and were given first salvage therapy (S1) for relapse, again with at least 4 months follow-up from relapse date. These 21 included patients referred to us at initial diagnosis or only at time of S1. The frequency with which they were transplanted (8/21; 38% 95%CI 18-62%) did not differ from the frequency with which SCT was done in CR1. However SCT was most commonly done as 2nd salvage therapy (4 cases), with 3 pts transplanted in CR2 or CR and only 1 given SCT as S1.10 of the 13 S1 pts never given SCT had available donors (3 related, 3 unrelated, 4 cord) with SCT not done because of high blasts and/or poor performance status. We conclude that although older and younger pts may be equally likely to receive SCT in CR1, failure to HLA type may be a major impediment to increasing rates of SCT in CR1. Although relapsed pts are transplanted as often as pts in CR1, such transplants are only rarely used as initial therapy of relapse. Disclosures: No relevant conflicts of interest to declare.

Allogeneic Hematopoietic Cell Transplantation For Patients With Mycosis Fungoides and Sezary Syndrome: The Experience Of The EBMT Lymphoma Working Party With An Extended Five-Year Follow Up

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2094-2094 ◽  
Author(s):  
Rafael F. Duarte ◽  
Ariane Boumendil ◽  
Francesco Onida ◽  
Ian H Gabriel ◽  
Reyes Arranz ◽  
...  
Keyword(s):  
Mycosis Fungoides ◽  
Hematopoietic Cell Transplantation ◽  
Performance Status ◽  
Stage Iv ◽  
Working Party ◽  
Poor Performance Status ◽  
Initial Report ◽  
Allogeneic Hct ◽  
Reduced Intensity

Abstract Purpose In 2010 the EBMT Lymphoma Working Party reported our experience on allogeneic HCT in patients with mycosis fungoides and SŽzary syndrome (MF/SS) in what remains the largest series on this topic published to date [JCO 2010; 28: 4492-4499]. Despite the encouraging results, the main shortcoming of our initial report was a limited follow up of 36 months; in particular, for a series in which 73% of the cases received a reduced-intensity conditioning prior to HCT. The purpose of this study is to analyze our experience in this setting with an extended follow up, including standard outcomes of non-relapse mortality (NRM), incidence of relapse/progression (R/P), progression-free survival (PFS) and overall survival (OS), as well as to identify factors associated with patient outcome 5 years after allogeneic HCT. Patients and Methods Sixty patients with MF (n=36) and SS (n=24) who received a first allogeneic HCT from matched related (mRD, n=45) or unrelated (mUD, n=15) donors between 1997 and 2007, included in our original series were analyzed: 37 men and 23 women, median age 46.5 years (22-66). Forty-four patients (73%) had TNM stage IV, and 40 (67%) were at advanced disease phase at transplantation, defined as either those on third or later complete response (CR), partial response (PR) or relapse/progression, or those primary refractory to systemic therapy. Forty-four patients (73%) received reduced-intensity (RIC) and only 16 (27%) myeloablative (MAC) conditioning regimens, with 25 (42%) undergoing T-cell depletion (TCD). Extended follow up data was collected from the EBMT Registry and closed in July 2013. Results With an extended median follow up in survivors of 60 months (4–117), allogeneic HCT continues to offer patients with MF/SS an advantageous estimated OS of 66% at 1 year, 54% at 3 years and 48% at 5 years (95% CI: 36% - 64%), and a first PFS of 41% at 1 year, 35% at 3 years and 33% at 5 years (95% CI: 23% - 48%). Disease R/P remains the main complication, with a total of 26 cases (43%) at a median of 3.8 months (1-37) after HCT. While 16 of them died from disease R/P, it is worth noting that at present 10 of these patients (38%) remain alive at last follow up, suggesting that after R/P, patients can be successfully rescued with donor lymphocyte infusions and other lines of therapy. Indeed, at last follow up, a total of 31 patients remain alive, and of these only 2 have active disease, while 29 of them are also in sustained or re-attained CR from their MF/SS. NRM has remained stable at 22% (13 cases; median 52 days from HCT, 8-403) in this analysis. As described in Table 1, the outcome of MF/SS patients 5 years after allogeneic HCT is primarily driven by the type of donor, the intensity of conditioning, and the status of the disease at the time of transplant. In addition, patients with a poor performance status (Karnofsky <70) have a higher risk of NRM, and patients receiving TCD, a higher incidence of disease R/P, none of which translate into a significant impact on OS. Conclusions Our data with a prolonged patient follow up provides a clearer picture of the value of allogeneic HCT as a therapeutic strategy for high-risk patients with advanced-stage MF/SS. They further suggest the existence of a clinically relevant graft-versus-MF/SS effect that provides prolonged survival with no evidence of disease to patients with advance phase at the time of transplant and even to many of those who relapse/progress after allogeneic HCT. This study identifies as well factors that may influence the overall outcome of these patients at a longer 5-year term after transplant. Disclosures: Dreger: Riemser Pharma : Consultancy, Honoraria, Research Funding.

Patient characteristics and survival outcomes associated with early versus delayed molecular testing in metastatic NSCLC.

2014 ◽  
Vol 32 (30_suppl) ◽  
pp. 211-211
Author(s):  
David A. Smith ◽  
Craig H. Reynolds ◽  
Debra A. Patt ◽  
Gregory Smith ◽  
Robyn K. Harrell ◽  
...  
Keyword(s):  
Small Sample Size ◽  
Performance Status ◽  
Patient Characteristics ◽  
Small Sample ◽  
Rank Test ◽  
Survival Outcomes ◽  
Poor Performance Status ◽  
Molecular Testing ◽  
Metastatic Nsclc

211 Background: Evidence-based guidelines recommend molecular testing for appropriate patients with advanced NSCLC at the time of diagnosis of adenocarcinoma. This study evaluated patient demographics, clinical characteristics and survival outcomes associated with early molecular testing (EMT) as compared to delayed molecular testing (DMT) in patients with metastatic NSCLC. Methods: Retrospective analysis of patients’ electronic medical records from The US Oncology Network Practices that utilize iKnowMed (iKM). Patients with a diagnosis of metastatic NSCLC between March 2011 and June 2012, >2 visits and >6 months of follow-up were eligible. EMT and DMT was defined as occurring <45 days and >45 days of diagnosis, respectively. Patient characteristics were compared using t-test and chi-square tests as appropriate. Logistic regression was used to predict the likelihood of higher performance status in the cohorts. Progression-free survival (PFS) and overall survival (OS) were compared using Cox proportional hazards models controlling for age, gender, stage at diagnosis, performance status and comorbidities. Results: A total of 350 patients were eligible and had a median follow-up of 17.3 months. Average age was 64, majority were female (55%) and diagnosed with adenocarcinoma (93%). There were no significant differences in demographic characteristics between EMT and DMT cohorts, however DMT patients were more likely to have ECOG 0 or 1 (OR=2.95, 95%CI=1.33-6.54, p=0.008). No difference in OS or PFS was observed between EMT and DMT patients, p>0.05 (log-rank test). However, poor performance status was found to increase risk of progression/death in multivariate OS and PFS analysis, p<0.02 and p<0.01, respectively. Conclusions: While patients undergoing EMT were nearly three times more likely to exhibit poorer performance status as compared to DMT cohort, their survival outcomes were no different, reinforcing the importance of molecular testing in these patients who may otherwise be less likely to receive treatment. Although limited to small sample size, results of this analysis call for further investigation of potential benefits of EMT in metastatic NSCLC in real-world setting.

Clinging to My Child: Mothers’ Experiences Taking Care of a Child Hospitalized with Leukemia

2020 ◽  
pp. 105477382095747
Author(s):  
Dasuel Lee ◽  
Sunhee Lee
Keyword(s):  
Qualitative Study ◽  
Study Design ◽  
Healthcare Providers ◽  
Sociocultural Context ◽  
Follow Up Care ◽  
Study Participants ◽  
Feeling Overwhelmed ◽  
Mothers Experiences ◽  
Taking Care

The purpose of this study was to investigate, within the sociocultural context of Korea, mothers’ experiences caring for their child being treated in a hospital for leukemia. Study participants included 11 mothers who visited a hospital for their child’s follow-up care after treatment for leukemia. The researchers investigated the mothers’ experiences in caring for their children using a qualitative study design. Through interviews, the researchers identified five categories of experiences among participants, including, “Death anxiety,” “Feeling guilty,” “Fulfilling responsibilities as a mom,” “Feeling overwhelmed by life,” and “Feeling grateful.” In the course of treatment, mothers tended to feel pressured to be a good mother, and sometimes felt overwhelmed by life. Healthcare providers need to grasp the difficulties faced by mothers taking care of their children hospitalized for treatment of leukemia, and must develop programs to reduce the burden on mothers and increase their families’ functioning.

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