The incidence of occult endocrinopathies in patients with cancer undergoing immunotherapy in community practice.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e14571-e14571
Author(s):  
Ahmed Abdalla ◽  
Aditi Singh ◽  
Hussein Gharib ◽  
Benjamin Huber ◽  
Sindhu Janarthanam Malapati ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Testosterone Level ◽  
Single Agent ◽  
Laboratory Data ◽  
Endocrine Function ◽  
Hormone Levels ◽  
Primary Indication ◽  
Number Of Patients ◽  
The Mean ◽  
Stimulating Hormone

e14571 Background: Immune checkpoint blockade (IO) can induce inflammation of the pituitary, thyroid or adrenal glands. This usually results in non-specific symptoms such as headache, low-energy, nausea and vomiting, which can be difficult to differentiate from symptoms associated with cancer and therapy-related symptoms. Therefore, the exact incidence of endocrinopathies is exceedingly difficult to estimate in community practices. Also, the variable methods of assessment, diagnosis, and monitoring used in different clinical trials make it challenging to precisely measure the incidence of endocrinopathies. Methods: This is a single-center retrospective chart review of patients diagnosed with cancer receiving immunotherapy for cancer treatment who had routine hormone levels checked during their treatment. Data collected includes tumor types and the types of IO agents used. Laboratory data collected included thyroid-stimulating hormone (TSH), testosterone level, follicular stimulating hormone (FSH), luteinizing hormone (LH), cortisol levels. Results: In total, 75 patients were included in the study. The primary indication for IO was lung cancer in 43 patients (57%), genitourinary tumors (12%), melanoma (12%) and head & neck cancers (5.3%). Single-agent nivolumab (39 patients) was the most common IO agent used followed by single-agent pembrolizumab (22 patients), ipilimumab (11 patients), atezolizumab (3 patients), avelumab (1 patient) (There was one patient who got nivolumab initially and then pembrolizumab). Nine patients were treated with ipilimumab/nivolumab combination. The mean number of cycles received was 9.1. The total number of patients who developed at least one abnormal hormone level was 57(76%), with 33 out of 74 (45%) patients had at least one abnormal TSH, 29 out of 44 (66%) patients had at least one abnormal testosterone level, 10 out of 49 (20.4%) patients had at least one abnormal FSH and/or LH level, 36 out of 52 (69%) patients had at least one abnormal cortisol level. The mean number of days from starting IO to develop the first abnormal laboratory result was 106 days. Conclusions: The incidence of endocrinopathy was significantly high in patients receiving IO in this study, which is higher than what is reported in previous clinical trials. This could be due to frequent testing in asymptomatic patients and strict laboratory cut-off values which is not always clinically meaningful. This finding may highlight the importance of routine monitoring of the endocrine function during IO treatment. Routine measurement of hormone levels can detect asymptomatic endocrinopathy which may warrant further work-up and treatment. These findings should be validated in a larger prospective study.

scholarly journals A Phase II Study of Nivolumab in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 467-467 ◽  
Author(s):  
N. Nora Bennani ◽  
Levi D Pederson ◽  
Pamela Atherton ◽  
Ivana Micallef ◽  
Joseph P. Colgan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
T Cell ◽  
Interim Analysis ◽  
Research Funding ◽  
Cell Lymphoma ◽  
Single Agent ◽  
Advisory Board ◽  
T Cell Lymphoma ◽  
Number Of Patients ◽  
Hyperprogressive Disease

Introduction: Peripheral T-cell lymphomas (PTCL) are a heterogeneous group of mature aggressive T-cell non-Hodgkin lymphomas. They carry a worse prognosis for most subtypes compared with their B-cell counterparts. Despite the recent approval of newer therapies, the response rate and duration of clinical benefit is short and the outlook for patients with relapsed/refractory (RR) PTCL remains poor. There is therefore a need for novel effective therapies in PTCL. Targeting the profoundly immunosuppressive tumor microenvironment (TME) in PTCL is one such approach. Preclinical data show that malignant cells in PTCL overexpress programmed death ligand 1 (PD-L1), which signals via programmed death-1 (PD-1) receptor, and provides an inhibitory signal further suppressing antitumor immunity. PD-1/PD-L1/2 interactions in PTCL are particularly complicated as both the receptor and ligands can be expressed on the malignant T-cell. While the use of anti-PD-1 blocking antibodies has shown remarkable efficacy particularly in relapsed Hodgkin lymphoma, only a small number of patients with PTCL have been treated with checkpoint blockade. We conducted an investigator-initiated phase 2 prospective study of single-agent nivolumab for RR PTCL. We report here the results of the prespecified interim analysis. Study design and patient selection: Nivolumab was given at a flat dose of 240 mg intravenously (IV) every 2 weeks for 8 cycles then 480 mg IV every 4 weeks starting cycle 9. The primary objective was to assess the overall response rate (ORR) defined as proportion of subjects achieving either a partial response (PR) or complete response (CR) within 12 cycles of treatment. Secondary objectives were to assess safety and tolerability of nivolumab in PTCL and to assess progression-free survival (PFS), duration of response (DOR) and overall survival (OS). Pre-planned sample size was 39, assuming that an ORR of 10% or less would be considered negative and an ORR of 30% or greater would warrant further study. We used a one-stage design with an interim analysis (upon enrolling 12 subjects) based on a Simon optimal design to assess efficacy. This design had a 90% power with a 1-sided 10% level test. The Duffy and Santner method was utilized to determine confidence intervals for the ORR. Kaplan-Meier methods were used to assess PFS, OS, and DOR. This study was sponsored by Bristol-Myers Squibb (NCT03075553). Results: Twelve patients who received at least one cycle of nivolumab were included in this interim analysis. Patient characteristics are illustrated in table 1. Half (6/12) of the patients had angioimmunoblastic T-cell lymphoma (AITL), 3/12 had PTCL, not otherwise specified (NOS), one had ALK negative anaplastic large cell lymphoma (ALK- ALCL). Most (11/12) were advanced stage (stage 4), had extranodal disease and half of the patients had received a prior autologous transplant. The ORR was 33% (4/12) (95% CI: 12.3 - 63.7%): 1 CR seen in ALK-ALCL; 2 PR, 1 in PTCL, NOS and 1 in enteropathy associated T-cell lymphoma; 1 CR in AITL. The median DOR was 3.6 months (95% CI: 1.9-6.9). The median PFS for all 12 patients was short at 1.9 months (95% CI: 1.5-8.7); median OS was 7.9 months (95% CI: 3.4-10.8) (Panel A). Hyperprogressive disease (defined as dramatic progression within 1 cycle of treatment) occurred in 4 patients. Observed grade 3 and higher adverse events (AEs) were as follows: non-hematologic AEs in 5/12 (41.7%), while hematologic AEs were seen in 3/12 (25%) patients. Conclusions: Nivolumab had modest clinical activity in patients with R/R PTCL and the study met the criteria at interim analysis to continue accrual. However, due to the high number of patients with hyperprogressive disease, the moderate activity of the drug, and short DOR, a decision was made to halt the study. These findings likely reflect the distinct biology of PTCL and should be considered when designing future studies using checkpoint inhibitors in these diseases. Further studies are indicated using nivolumab in combination (rather than a single-agent) and use of biomarkers to better predict the responders. Disclosures Bennani: Purdue Pharma: Other: Advisory board; Adicet Bio: Other: Advisory board; Seattle Genetics: Other: Advisory board; Adicet Bio: Other: Advisory board; Purdue Pharma: Other: Advisory board; Adicet Bio: Other: Advisory board; Seattle Genetics: Other: Advisory board; Bristol-Myers Squibb: Research Funding; Kite Pharma: Other: Advisory board; Bristol-Myers Squibb: Research Funding; Kite Pharma: Other: Advisory board; Purdue Pharma: Other: Advisory board; Bristol-Myers Squibb: Research Funding; Kite Pharma: Other: Advisory board; Seattle Genetics: Other: Advisory board. Nowakowski:Selvita: Membership on an entity's Board of Directors or advisory committees; NanoString: Research Funding; Celgene: Consultancy, Research Funding; Bayer: Consultancy, Research Funding; Curis: Research Funding; F. Hoffmann-La Roche Ltd: Research Funding; Genentech, Inc.: Research Funding; MorphoSys: Consultancy, Research Funding. Ansell:Merck: Other: research funding for clinical trials; Seattle Genetics: Other: research funding for clinical trials; Takeda: Other: research funding for clinical trials; Bristol Myers Squibb: Other: research funding for clinical trials; Regeneron: Other: research funding for clinical trials; Affimed: Other: research funding for clinical trials; Pfizer: Other: research funding for clinical trials; AI Therapeutics: Other: research funding for clinical trials.

scholarly journals Outcomes following transsphenoidal surgical management of incidental pituitary adenomas: a series of 52 patients over a 17-year period

2019 ◽  
Vol 130 (5) ◽  
pp. 1584-1592 ◽  
Author(s):  
Justin Seltzer ◽  
Michelle A. Wedemeyer ◽  
Phillip A. Bonney ◽  
John D. Carmichael ◽  
Martin Weiss ◽  
...  
Keyword(s):  
Visual Field ◽  
Pituitary Adenomas ◽  
Laboratory Data ◽  
Extent Of Resection ◽  
Endocrine Function ◽  
Csf Leak ◽  
Progression Rate ◽  
Tumor Diameter ◽  
Csf Rhinorrhea ◽  
Primary Indication

OBJECTIVEIncidental pituitary adenomas (IPAs) are commonly discovered during cranial imaging evaluations obtained for unrelated indications. The optimal management of IPA remains controversial. The authors investigated the outcomes and safety of the surgical treatment of IPAs at their institution.METHODSClinical outcome data for 1692 patients surgically treated for pituitary adenomas at the Keck Medical Center of USC/USC Pituitary Center over a 17-year period (1999–2016) were reviewed to identify all cases with surgically managed IPAs. Clinical characteristics reviewed in this retrospective analysis included patient demographics, endocrine laboratory data, visual field examinations, and MRI results. Intraoperative data reviewed included requirement for CSF leak repair, surgical complications, and estimated extent of resection. Postoperative data collected included pathology results, length of stay, postoperative complications, endocrine outcomes, readmission rates, and long-term outcomes, including extent of resection noted on postoperative imaging studies and tumor progression and/or recurrence.RESULTSFifty-two patients (3.1% of all cases) underwent transsphenoidal surgery for IPA. The median age at surgery was 61 years (range 31–86 years). The most common reasons for neuroimaging included trauma (19%), stroke/transient ischemic attack (15%), and sinonasal disease (15%). Visual field deficits were present in 15% of bedside examinations, and among the 22 patients sent for formal testing, 54.5% were noted to have deficits. Preoperative endocrine function was normal in 69% of patients, which includes 3 patients (5.8%) having isolated hyperprolactinemia consistent with a stalk effect without other hormonal dysfunction. The average maximal tumor diameter was 20.9 mm (8–50 mm; data available in 35 patients). The most common primary indication for surgery was compression of the chiasm or vision loss (52%); other major considerations included tumor growth, a young patient age, and identified endocrine abnormalities. Intraoperative CSF leak repair was performed in 56% of patients, and 1 patient (2%) developed postoperative CSF rhinorrhea treated with lumbar drainage. The median hospital stay was 2 days. There were no deaths or major complications. Three patients (5.8%) developed transient diabetes insipidus. Over a mean follow-up of 61 months, 4 patients (50.0%) reported improved headaches and 6 (54.5%) reported improvement in their visual deficits. Four patients (25%) had improved endocrine function, including one with resumption of menstruation and another with remission of acromegaly. One patient (2.4%) reported new postoperative headache, and none experienced worsened vision. Four patients (10.5%) developed new single-axis hypopituitarism and 1 (2.6%) developed new panhypopituitarism. The overall recurrence/progression rate on neuroimaging was 9.6% at a mean of 80 months.CONCLUSIONSTranssphenoidal resection of IPAs, when appropriate, can be performed safely at experienced treatment centers. Incidental pituitary adenomas should be evaluated and treated as indicated, especially in younger patients at risk for endocrine or visual dysfunction.

scholarly journals P439 Patient’ recruitment for a Phase 3 inflammatory bowel disease (IBD) programme is significantly increased when accessing the CT-SCOUT™ platform

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S397-S398
Author(s):  
Y Bouhnik ◽  
X Roblin ◽  
R Mrad ◽  
X Hebuterne ◽  
D Laharie ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Recruitment Rate ◽  
Patient Recruitment ◽  
Potential Candidate ◽  
Open Label ◽  
Phase 3 ◽  
Web Based ◽  
Number Of Patients ◽  
The Mean ◽  
Post Hoc

Abstract Background The main issue when validating new molecules in the field of IBD is insufficient patient recruitment into clinical trials, resulting in a considerable delay and cost increase. The selection of the best recruiting sites is a long and difficult process, especially since study sponsor has no visibility on the activity of the sites, and the sites have no penalties if the objectives are not achieved. The CT-SCOUT™ platform is a web-based solution to help clinicians to pre-screen potential candidate, facilitating the coordination of the research team and providing sponsor and principal investigator visibility into patient recruitment efforts and status on the site. We aimed to compare the recruitment rate in sites using the application according to Premium or Freemium modalities and in sites not equipped with CT-SCOUT™ for IBD clinical trials. Methods We conducted a prospective, multicentre, open-label, observational and comparative study in 25 sites participating in a selected phase 3 IBD clinical trials in France. All sites were proposed to be equipped with CT-SCOUT™, and the recruitment rate was compared according to 3 modalities: a) the Premium mode, giving access to all the functionalities of the application (including specific inclusion/exclusion criteria, possibility of sending notification to the team) in counterpart of which they undertook to use the application; b) the Freemium mode, a basic functionality that only gives the name of the study in the first selection phase; c) sites who were not interested to be equipped. The primary endpoint was the mean number of patients randomised per site per month. Patients screened and those finally randomised were compared in sites equipped (Premium or Freemium) and non-equipped using one-way ANOVA followed by post-hoc Tukey test. Results During the recruitment period from 4 to 36 months (mean 24.8 months), 221 and 130 patients were screened and randomised, respectively. The mean number of patients screened and randomised per site per month according to CT-SCOUT™ equipment is reported in the figure below. Conclusion This study shows that sites not equipped with CT-SCOUT™ recruit only a few patients. Among the equipped sites, those with Premium access have a significantly higher randomisation rate than those with limited functionality. Sites equipped with digital pre-screening support to facilitate patient recruitment and provide the sponsor visibility are the best candidates for trials.

scholarly journals P675 CT-Scout platform, the digital solution to boost patient recruitment in inflammatory bowel disease clinical trials: A multicentre prospective observational comparative study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S552-S552
Author(s):  
Y Bouhnik ◽  
X Hebuterne ◽  
M Raith ◽  
A Amiot ◽  
C Tanasa Stefanescu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Recruitment ◽  
Open Label ◽  
Multicentric Study ◽  
Global Issue ◽  
Number Of Patients ◽  
Secondary Endpoints ◽  
The Mean ◽  
Post Hoc ◽  
Patient Enrollment

Abstract Background The main issue to validating new molecules in the field of IBD is insufficient patient enrollment into clinical trials, resulting in premature trials termination and cost increase. CT-SCOUT™ platform is a web-based solution to help clinicians to pre-screen potential candidates and facilitating the coordination of the research team. Our aim was to compare the number of patients enrolled in IBD clinical trials in sites equipped or not with CT-SCOUT™. Methods We conducted a prospective, multicenter, open-label, observational study in sites participating to phase 3 trials evaluating the efficacy and safety of etrolizumab in ulcerative colitis (UC, Hickory) and in Crohn’s disease (CD, Bergamot). Recruitment figures were provided by the sponsor, and we considered the 21 French sites equipped with CTscout and 134 sites in other countries not equipped with CT-SCOUT™. The primary endpoint was the mean number of patients randomised per site in both trials. Secondary endpoints included a mean number of patients randomised in each study. Patients screened and those finally randomised were compared in sites equipped and non-equipped using one-way ANOVA followed by post-hoc Tukey test and Mann–Whitney test. Results During the observational period of 40 months (September 2015–December 2018), 644 and 289 patients were screened and randomised in Hickory and/or Gardenia, respectively. There were 307 and 149 patients in 78 sites for Hickory, and 337 and 140 patients for Bergamot in 102 sites. The mean numbers of screened and randomised patients in CT-SCOUT™ equipped sites vs. non-equipped are given in the table. The mean number of patients randomised in Hickory in CT-SCOUT™ sites increased by 4.0 folds as compared with non-equipped sites (p < 0.001). The mean number of patients randomised in Bergamot in CT-SCOUT™ equipped sites has been increased by 1.9-folds as compared with non-equipped sites (p = 0.009). Conclusion This multicentric study demonstrated a significant increase in patient recruitment in IBD clinical trials. Randomisation rates were twice to four times higher in equipped sites compared with non-equipped ones. CT-SCOUT™ appears to be a promising digital solution to the global issue of patient enrollment in clinical trials.

Evaluation of cardiovascular status in clinical trials in breast cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e14038-e14038
Author(s):  
Ohad Oren ◽  
Michal Oren
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Treatment Options ◽  
Single Agent ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
P Value ◽  
Number Of Patients ◽  
Cardiac Status

e14038 Background: With the expansion of treatment options in oncology, patients are now increasingly exposed to potentially cardio-injurious compounds. Nevertheless, many clinical trials do not assess the cardiac status of participants, from time of enrollment to study completion. Methods: We reviewed the landmark clinical trials of each of the single-agent chemotherapies specified by the NCCN for use in locally advanced/metastatic breast cancer. We analysed the cardiovascular exclusion criteria, baseline cardiac evaluation as well as cardiac surveillance of patients in each study. We then investigated the literature in the years following each index publication, scrutinising for evidence of cardiac toxicity. Results: 14 phase 2/3 studies were analysed. The total number of patients was 2,522. 42.8% (6/14) of the studies excluded patients with clinically-determined cardiovascular disease, 66.6% (4) of which specified normal EF as a pre-requisite for enrollment. 42.8% (6/14) of the studies evaluated the baseline cardiovascular function of participants using EKG or TTE. 35.7% (4/14) of the studies included a more rigorous monitoring that included serial EKGs and/or TTEs. New Heart Failure (HF) occurred in 1.63% (20/1226) and 0.87% (9/1024) of patients in the more- and less- rigorous trials, respectively (P value = 0.11). Subsequent follow-up studies (published a mean of 8.5 years later) disclosed significantly higher incidence of symptomatic HF (range 2.3-28.0%) with 3 (of 4) chemotherapies in the more-rigorous study group (doxorubicin, cyclophosphamide, epirubicin) and 1 (of 10) chemotherapies in the less-rigorous group (docetaxel). Conclusions: The majority of clinical studies in breast cancer do not prospectively assess cardiac status beyond a pure clinical assessment. The discrepancy between the toxicity profile shown by original studies and that detected in subsequent investigations implies that the tools currently used to evaluate the cardiovascular status of enrollees may be insufficiently sensitive in predicting the development of HF. Novel tools (circulating markers, imaging) and longer follow-up periods are needed to ascertain the cardiotoxic profile of new chemotherapies.

scholarly journals Acyclovir Cream for Treatment of Herpes Simplex Labialis: Results of Two Randomized, Double-Blind, Vehicle-Controlled, Multicenter Clinical Trials

2002 ◽  
Vol 46 (7) ◽  
pp. 2238-2243 ◽  
Author(s):  
Spotswood L. Spruance ◽  
Robert Nett ◽  
Thomas Marbury ◽  
Ray Wolff ◽  
James Johnson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
The United States ◽  
Vehicle Control ◽  
Herpes Labialis ◽  
Double Blind ◽  
Number Of Patients ◽  
The Mean ◽  
Multicenter Clinical Trials ◽  
Acyclovir Cream

ABSTRACT Acyclovir cream has been available for the treatment of herpes labialis in numerous countries outside the United States for over a decade. Evidence for its efficacy comes from a few small clinical trials conducted in the 1980s. To examine more comprehensively the efficacy and safety of this formulation, we conducted two independent, identical, parallel, randomized, double-blind, vehicle-controlled, large-scale multicenter clinical trials. Healthy adults with a history of frequent herpes labialis were recruited from the general population, screened for eligibility, randomized equally to 5% acyclovir cream or vehicle control, given study medication, and told to self-initiate treatment five times daily for 4 days beginning within 1 h of the onset of a recurrent episode. The number of patients who treated a lesion was 686 in study 1 and 699 in study 2. In study 1, the mean duration of episodes was 4.3 days for patients treated with acyclovir cream and 4.8 days for those treated with the vehicle control (hazards ratio [HR] = 1.23; 95% confidence interval [CI], 1.06 to 1.44; P = 0.007). In study 2, the mean duration of episodes was 4.6 days for patients treated with acyclovir cream and 5.2 days for those treated with the vehicle control (HR = 1.24; 95% CI, 1.06 to 1.44; P = 0.006). Efficacy was apparent whether therapy was initiated “early” (prodrome or erythema lesion stage) or “late” (papule or vesicle stage). There was a statistically significant reduction in the duration of lesion pain in both studies. Acyclovir cream did not prevent the development of classical lesions (progression to vesicles, ulcers, and/or crusts). Adverse events were mild and infrequent.

scholarly journals Evaluation of Aminoglycosides Consumption in Open Heart Surgery Based on the Defined Daily Dose Index

2020 ◽  
Author(s):  
Golpar Gholizadeh Shirdarreh ◽  
Gohar Eslami ◽  
Aria Soleimani ◽  
Ebrahim Salehifa
Keyword(s):  
Side Effects ◽  
Creatinine Clearance ◽  
Heart Surgery ◽  
Laboratory Data ◽  
Open Heart Surgery ◽  
Defined Daily Dose ◽  
Open Heart ◽  
Number Of Patients ◽  
Daily Dose ◽  
The Mean

Background: Resistance to antibiotics, including aminoglycosides  (AMG) is one of the problems associated with inappropriate administration of broad-spectrum antibiotics. Objectives: This study aimed to assess the clinical features of aminoglycosides consumption based on the Defined Daily Dose (DDD) index in open heart surgery. Methods: This study was done on 268 patients who underwent heart surgery during 2015 and 2016. Clinical and demographic characteristics, laboratory data, and aminoglycoside-related data such as dose and the total duration of administration were collected through a questionnaire designed by the authors. The patients’ DDD/100 bed-days were calculated, too. Results: Out of 268 patients, 170 patients (63.4%) were male. The Mean±SD age of the patients was 60.65±10.71 years and the Mean±SD duration of hospitalization was 12.19±7.02 days. Ischemic heart disease was the most prevalent cause of hospitalization. The Mean duration of receiving aminoglycosides was 3.61 days. In 134 patients (50%), creatinine clearance was less than 60 mL/min during aminoglycosides administration. In 25 patients (9.32%), a 50% increase in serum creatinine during receiving aminoglycosides was observed. Creatinine clearance had not been calculated for any patient. Conclusion: In this study, monitoring the side effects of aminoglycosides and the serum concentration was not routinely performed. Dose adjustment of aminoglycosides based on renal function test was not considered in a large number of patients and as a result, the dose was inappropriate in many patients. Therefore, it is recommended that the guidelines of drug usage were followed and the patients were monitored more closely for side effects.

PENINGKATAN KUALITAS HIDUP MELALUI LOGOTERAPI PADA KLIEN YANG MENJALANI HEMODIALISIS

2019 ◽  
Vol 11 (1) ◽  
pp. 9-18
Author(s):  
Abdul Wakhid ◽  
Ana Puji Astuti ◽  
Maya Kurnia Dewi
Keyword(s):  
Quality Of Life ◽  
Renal Failure ◽  
Test Group ◽  
Sampling Technique ◽  
T Test ◽  
P Value ◽  
Number Of Patients ◽  
Post Test ◽  
The Mean

Logoterapi merupakan terapi untuk menemukan makna positif dibalik sebuah kejadian yang tidak diharapkan. Logoterapi dilaksanakan secara individu maupun berkelompok dalam bentuk konseling dan berorientasi pada pencarian makna hidup individu. Tujuan logoterapi meningkatkan makna pengalaman hidup individu yang diarahkan kepada pengambilan keputusan yang bertanggung jawab. Penelitian ini dilakukan dengan menggunakan rancangan pre-experiment dengan metode pre and post test group, artinya pengumpulan data dilakukan terhadap responden untuk membandingkan kualitas hidup sebelum dan sesudah dilakukan intervensi. Teknik pengambilan sampel dilakukan dengan metode total sampling yaitu pengambilan seluruh sampel dengan tetap memperhatikan kriteria yang telah ditetapkan. Jumlah pasien yang menjalani hemodialisis di RSUD Ungaran sebanyak 21 orang dan di RSUD Ambarawa sebanyak 25 pasien. Analisis data dilakukan dengan menggunakan uji t test dependent. Hasil penelitian didapatkan bahwa dari 46 responden didapatkan rata-rata skor kualitas hidup pasien yang mejalani hemodialisis sebesar 60.22 dengan skor terrendah 55 dan skor tertinggi 69. Bahwa dari 46 responden didapatkan rata-rata skor kualitas hidup pasien yang mejalani hemodialisis sebesar 88.72 dengan skor terrendah 79 dan skor tertinggi 103. Hasil uji statistik dengan uji t test dependent diketahui ada pengaruh logoterapi terhadap kemampuan memaknai hidup pada klien yang menjalani hemodialisis di RSUD Kabupaten Semarang (p value: 0,0001). Saran perlunya peningkatan kemampuan perawat dalam memberikan layanan kesehatan termasuk pemberian atau pemanduan penemuan makna hidup bagi pasien hemodialysis, agar selain dengan hemodialysis, ada faktor internal dari pasien yang dapat dijadikan sebagai motivasi untuk sembuh dari penyakit.   Kata Kunci: Logoterapi, kualitas hidup   IMPROVE THE QUALITY OF LIFE OF PATIENTS WITH RENAL FAILURE WHO UNDERWENT HEMODIALYSIS   ABSTRACT Logotherapy is a therapy to discover the positive meaning behind an unexpected event. Logotherapy is carried out individually or in groups in the form of counseling and oriented to the search for the meaning of individual life. This study aims to improve the quality of life of patients with renal failure who underwent hemodialysis. This research was conducted by using pre-experiment with pre-post test study. The sampling technique was done by the convenience sampling. The number of patients undergoing hemodialysis as many as 46 respondents. Data analysis was done by using test t test dependent. The result showed that from 46 respondents got the mean of quality of life of patients who had hemodialysis 60.22 with lowest score 55 and highest score 69. Whereas from 46 respondents got the mean score of life quality of patients who had hemodialysis 88.72 with score the lowest score 79 and the highest score 103. The result of statistical test with t test dependent is known there is influence of logoterapi to the ability of meaningful life on client who undergo hemodialysis at Semarang Regency hospitals (p value: 0.0001). Advice on the need to improve the nurse's ability to provide health services, including the provision or guidance of the discovery of the meaning of life for hemodialysis patients, in addition to hemodialysis, there are internal factors of the patient that can be used as a motivation to recover from illness.   Keywords: Logotherapy, quality of life, kidney failure.  

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