scholarly journals Quality-of-Life Priorities in Patients with Thyroid Cancer: A Multinational European Organisation for Research and Treatment of Cancer Phase I Study

Thyroid ◽  
2016 ◽  
Vol 26 (11) ◽  
pp. 1605-1613 ◽  
Author(s):  
Susanne Singer ◽  
Olga Husson ◽  
Iwona M. Tomaszewska ◽  
Laura D. Locati ◽  
Naomi Kiyota ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Thyroid Cancer ◽  
Phase I ◽  
Phase I Study ◽  
European Organisation

Subjective symptoms and quality of life in healthy subjects during a phase I study

1996 ◽  
Vol 51 (3-4) ◽  
pp. 215-219 ◽  
Author(s):  
R. Schüppel ◽  
B. Boos ◽  
G. Bühler ◽  
M. Lataster ◽  
T. Peters
Keyword(s):  
Quality Of Life ◽  
Phase I ◽  
Healthy Subjects ◽  
Phase I Study ◽  
Subjective Symptoms

scholarly journals A phase I study of MR-HIFU hyperthermia (HT) with radiation (RT) and chemotherapy (CT) for recurrent rectal cancer.

2019 ◽  
Vol 5 (suppl) ◽  
pp. 78-78
Author(s):  
William Chu ◽  
Yuexi Huang ◽  
Samuel Pichardo ◽  
Robert Staruch ◽  
Ari Partanen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rectal Cancer ◽  
Phase I ◽  
Phase I Study ◽  
Intraoperative Complications ◽  
Cancer Control ◽  
Late Toxicity ◽  
Recurrent Rectal Cancer ◽  
Cumulative Number

78 Background: HT may improve cancer control and quality of life by sensitizing tumors to RT and CT. Inoperable recurrent rectal cancer has marginal outcomes with current retreatment regimens. We report the results from a first-in-human phase I study of MR-HIFU hyperthermia combined with RT and CT for recurrent rectal cancer. Methods: This ethics-approved study enrolled 6 patients fit for re-irradiation and chemotherapy; and with a MRI-visible and HIFU-accessible lesion. Patients received 30.6 Gy (17 fractions) and daily oral capecitabine, plus MR-HIFU HT immediately before RT on days 1, 8, and 15. Primary objectives were safety (acute toxicity) and treatment feasibility. Secondary objectives included late toxicity, pain palliation, quality of life, and radiologic response. HT was delivered with the Sonalleve MR-HIFU system on a 3T MRI. MR-based feedback control parameters were prescribed to achieve a mean temperature of 42.5°C in an 18 mm diameter target region for 30 minutes without exceeding 45°C. Results: One patient withdrew after completing 1/3 HT sessions due to scheduling and sedation difficulties. Five patients completed HT, RT and CT. There were no intraoperative complications, no adverse events or unintended tissue damage attributable to HT, RT, or CT. Table shows the best single continuous HT and mean temperatures (T90, T10), cumulative time in range (TIR), cumulative number of equivalent minutes at 43oC(CEM43) and day 90 imaging response. Sonication and MRI suite times were 36±13 and 226±78min. Conclusions: MR-HIFU HT was safely delivered in patients with recurrent rectal cancer. Treatment planning and patient set-up times decreased while beam-on time increased with experience. MR-HIFU HT combined with RT and CT appears feasible for primary tumours. Clinical trial information: NCT02528175. [Table: see text]

Phase I study of SNK01 (autologous non-genetically modified natural killer cells with enhanced cytotoxicity) in refractory metastatic solid tumors.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e15024-e15024
Author(s):  
Sant P. Chawla ◽  
Katherine M Kim ◽  
Victoria S. Chua ◽  
Omid Jafari ◽  
Paul Y. Song
Keyword(s):  
Quality Of Life ◽  
Phase I ◽  
Nk Cells ◽  
Cancer Patients ◽  
Solid Tumors ◽  
Phase I Study ◽  
Nk Cell ◽  
Heavily Pretreated ◽  
Tumor Types

e15024 Background: Natural Killer (NK) cells possess the innate ability to detect transformed cancer cells and kill them, thus playing a key role in cancer immunosurveillance and antitumor immunity. In general, prior NK cell therapies have not shown efficacy in solid tumors and the expansion of NK cells in cancer patients to clinically therapeutic doses is quite challenging, making allogenic preferable to autologous treatment. SNK01 is a first-in-kind, autologous non-genetically modified NK cell therapy with enhanced cytotoxicity which can be consistently produced even from heavily pretreated cancer patients, and has been shown to have efficacy against numerous solid tumor types in preclinical studies. Methods: In this single-arm Phase I study (NCT03941262) to investigate the safety and efficacy of SNK01, patients with refractory metastatic solid tumors were treated in a 3 + 3 dose escalation study with five weekly infusions of SNK01 at 1, 2, or 4 x 109 cells per infusion. Primary endpoint is safety and quality of life (QoL), and secondary endpoint is objective response rate (ORR). Results: Seven of nine planned patients have been enrolled up to date and five have completed treatment. All patients have rapidly progressive metastatic disease and have received an average of five lines of prior therapy. Tumor types include one non-small lung cancer, one colorectal cancer, and five sarcomas. Median age is 52 (32-62). All patients have had successful expansion and cytotoxic enhancement of their NK cells. Three patients have completed 1 x 109 SNK01 and two patients have completed 2 x 109 SNK01. There have been no adverse events according to NCI-CTCAE v 5.0 or any cytokine release syndrome, and all patients have reported an overall improvement in QoL. At week 9, three of three patients at the 1 x 109 dose and one of two at the 2 x 109 achieved a best overall response of stable disease as per RECIST 1.1. Conclusions: Expanding and increasing the cytotoxicity of NK cells in our heavily pretreated patients has been consistently reliable. SNK01 monotherapy has been very safe and well tolerated in patients with rapidly progressive solid tumors. MTD has not been reached and dose escalation is ongoing. Evaluation of anti-tumor activity is ongoing, but at a minimum, SNK01 appears to slow and possibly halt progression in very aggressive disease and improve quality of life while improving the overall quality of life. The remaining two planned patients are currently being enrolled and a full update will be presented. Clinical trial information: NCT03941262 .

How did partners experience cancer patients' participation in a phase I study? An observational study after a patient's death

2015 ◽  
Vol 14 (3) ◽  
pp. 241-249 ◽  
Author(s):  
Simone M.C.H. Langenberg ◽  
Marlies E.W.J. Peters ◽  
Winette T.A. van der Graaf ◽  
Anke N. Machteld Wymenga ◽  
Judith B. Prins ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psychological Distress ◽  
Observational Study ◽  
Phase I ◽  
Phase I Study ◽  
Complicated Grief ◽  
Well Being ◽  
Negative Consequences ◽  
Phase I Studies

AbstractObjective:It can be assumed that patients' participation in a phase I study will have an important impact on their partners' life. However, evaluation of partners' experiences while patients are undergoing experimental treatment and of their well-being after the patient's death is lacking. We aimed to explore partners' experience of patients' participation in phase I studies and to investigate their well-being after a patient's death.Method:This was an observational study conducted after the patient's death. Partners of deceased patients who had participated in a phase I study completed a questionnaire designed by us for experience evaluation and the Beck Depression Inventory for Primary Care, the Hospital Anxiety and Depression Scale, the Inventory of Traumatic Grief, and the RAND-36 Health Survey.Results:The median age of the 58 participating partners was 58 years (range: 51–65), and 67% was female. Partners reported negative effects on patients' quality of life, but only 5% of partners regretted patients' participation. Approximately two years after the patients' death, 19% of partners scored for depression, 36% for psychological distress, and 46% for complicated grief, and partners generally scored significantly lower on social and mental functioning compared to normative comparators.Significance of Results:Although partners reported negative consequences on patients' quality of life, most did not regret patients' participation in the phase I studies. Prevalence of depression, psychological distress, and complicated grief seemed important problems after a patient's death, and these must be considered when shaping further support for partners of patients participating in phase I trials.

scholarly journals The TELE-DD project on treatment nonadherence in the population with type 2 diabetes and comorbid depression

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Juan Francisco Roy ◽  
María Luisa Lozano del Hoyo ◽  
Fernando Urcola-Pardo ◽  
Alicia Monreal-Bartolomé ◽  
Diana Cecilia Gracia Ruiz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Type 2 Diabetes ◽  
Phase I ◽  
Clinical Depression ◽  
Point Prevalence ◽  
Diabetic Patients ◽  
Comorbid Depression ◽  
Shared Risk

AbstractDiabetic patients have increased depression rates, diminished quality of life, and higher death rates due to depression comorbidity or diabetes complications. Treatment adherence (TA) and the maintenance of an adequate and competent self-care are crucial factors to reach optimal glycaemic control and stable quality of life in these patients. In this report, we present the baseline population analyses in phase I of the TELE-DD project, a three-phased population-based study in 23 Health Centres from the Aragonian Health Service Sector II in Zaragoza, Spain. The objectives of the present report are: (1) to determine the point prevalence of T2D and clinical depression comorbidity and treatment nonadherence; (2) to test if HbA1c and LDL-C, as primary DM outcomes, are related to TA in this population; and (3) to test if these DM primary outcomes are associated with TA independently of shared risk factors for DM and depression, and patients’ health behaviours. A population of 7,271 patients with type-2 diabetes and comorbid clinical depression was investigated for inclusion. Individuals with confirmed diagnoses and drug treatment for both illnesses (n = 3340) were included in the current phase I. A point prevalence of 1.9% was found for the T2D-depression comorbidity. The prevalence of patients nonadherent to treatment for these diseases was 35.4%. Multivariate analyses confirmed that lower diabetes duration, increased yearly PCS visits, HbA1c and LDL-C levels were independently related to treatment nonadherence. These findings informed the development of a telephonic monitoring platform for treatment of nonadherence for people with diabetes and comorbid depression and further trial, cost-effectiveness, and prognostic studies (phases II and III).

scholarly journals Health-Related Quality of Life in Asian Differentiated Thyroid Cancer Survivors

2021 ◽  
Vol 28 ◽  
pp. 107327482110297
Author(s):  
Wing-Lok Chan ◽  
Horace Cheuk-Wai Choi ◽  
Brian Lang ◽  
Kai-Pun Wong ◽  
Kwok-Keung Yuen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Thyroid Cancer ◽  
Cancer Survivors ◽  
Differentiated Thyroid Cancer ◽  
Summary Score ◽  
Health Related Quality ◽  
Factors Associated ◽  
Related Quality ◽  
Health Related

Background: Health-related quality of life (HRQoL) is important for differentiated thyroid cancer survivors, but data for Asian survivors is lacking. This study aimed to have an overview of, and identify any disease-or treatment-related factors associated with, HRQoL in Asian differentiated thyroid cancer survivors. Patients and Methods: Thyroid cancer survivors were recruited from the thyroid clinics at Queen Mary Hospital, Hong Kong from February 2016 to December 2016. All adult differentiated thyroid cancer patients with stable disease more than or equal to 1 year received a survey on HRQoL using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and Thyroid cancer specific quality of life (THYCA-QoL) questionnaire. Clinical information was collected retrospectively from the computerized clinical management system. To identify factors associated with poor HRQoL, univariable and stepwise multivariable regression analysis were performed. Results: A total of 613 survivors completed the questionnaires (response rate: 82.1%; female: 80.1%; median survivorship: 7.4 years (range: 1.0-48.2 years)). The QLQ-C30 summary score mean was 84.4 (standard deviation (SD): 12.7) while the THYCA-QoL summary score mean was 39.9 (SD: 9.7). The 2 highest symptom subscales were fatigue (mean: 26.4, SD: 20.6) and insomnia (mean: 26.2, SD: 27.6). Factors associated with worse HRQoL included serum thyrotropin (TSH) greater than 1.0 mIU/L, unemployment, and concomitant psychiatric disorders. Concomitant psychiatric illness (n = 40/613, 6.5%) also showed significant association with most of the symptom and functional subscales. Conclusions: Fatigue and insomnia were the 2 most common symptoms experienced by our differentiated thyroid cancer survivors. Long-term survivorship care with monitoring serum TSH level, supporting return-to-work and screening for concomitant psychiatric disorders should be offered.

scholarly journals Risk Factors of Deterioration in Quality of Life Scores in Thyroid Cancer Patients After Thyroidectomy

2019 ◽  
Vol Volume 11 ◽  
pp. 10593-10598 ◽  
Author(s):  
Jie Li ◽  
Ling Bo Xue ◽  
Xiao Yi Gong ◽  
Yan Fang Yang ◽  
Bu Yong Zhang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Risk Factors ◽  
Thyroid Cancer ◽  
Cancer Patients
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