scholarly journals Androgen replacement therapy for cancer-related symptoms in male advanced cancer patients: study protocol for a randomised prospective trial (ARTFORM study)

2017 ◽  
Vol 64 (3.4) ◽  
pp. 202-204 ◽  
Author(s):  
Kouji Izumi ◽  
Kazuyoshi Shigehara ◽  
Takahiro Nohara ◽  
Kazutaka Narimoto ◽  
Yoshifumi Kadono ◽  
...  
Keyword(s):  
Replacement Therapy ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Study Protocol ◽  
Prospective Trial ◽  
Advanced Cancer Patients ◽  
Androgen Replacement Therapy

Development, and Evaluation of a Decision Aid to Support Patients’ Participa-tory Decision-making on Tumor-specific and Palliative Therapy in Advanced Cancer Patients: A Study Protocol. (Preprint)

2020 ◽  
Author(s):  
Katsiaryna Laryionava ◽  
Jan Schildmann ◽  
Michael Wensing ◽  
Ullrich Wedding ◽  
Bastian Surmann ◽  
...  
Keyword(s):  
Health Care ◽  
Decision Making ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Health Care Providers ◽  
Study Protocol ◽  
Care Providers ◽  
Advanced Cancer Patients ◽  
Design Study

BACKGROUND To support advanced cancer patients, for whom standard therapy is no longer avail-able, and their oncologists in therapy decisions, we aim to develop a decision-making aid (DA) in a multi-phased bicentric study. The DA aims to help patients to better un-derstand risks and benefits of available treatment options including the options of standard palliative care, off-label drug use within an individual treatment plan and involvement in clinical trials. OBJECTIVE This study protocol outlines the development and testing of a DA in a pre-post design study targeting at a heterogeneous population of advanced cancer patients. METHODS In phase I, The DA will be developed after of decisional needs of patients and views of health care providers based on face-to face interviews and focus groups discus-sions. Subsequently, the DA will be alpha-tested and redrafted, as necessary, in phase II. In phase III, the DA will be (1) beta-tested with patients and oncologists and (2) assessed by experts. In the last project phase, we will run a pre-post design study with n= 70 doctor-patient-encounters to access improvements on primary study outcome, i.e. patients’ level of decisional conflict. In addition, the user ac-ceptance will be tested. RESULTS Interviews with cancer patients, oncologists and health care providers have been completed. CONCLUSIONS A unique feature of this study is the development of a DA for patients with different types of advanced cancer, which covers a wide range of topics relevant for patients near the end of life such as forgoing cancer-specific therapy and patients’ inclusion in clinical trials. CLINICALTRIAL NCT04606238 https://clinicaltrials.gov/ct2/show/NCT04606238

scholarly journals Programmable Pump for Intrathecal Morphine Delivery to Cisterna Magna: Clinical Implications in Novel Management of Refractory Pain Above Middle Thoracic Vertebrae Level Utilizing a Prospective Trial Protocol and Review

2021 ◽  
Vol 11 (3) ◽  
Author(s):  
Chang Sun ◽  
Yu-Tong Wang ◽  
Yu-Jie Dai ◽  
Zhi-Hui Liu ◽  
Jing Yang ◽  
...  
Keyword(s):  
Pain Relief ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Short Form ◽  
Intrathecal Morphine ◽  
Prospective Trial ◽  
Depression Scale ◽  
Thoracic Vertebrae ◽  
Advanced Cancer Patients ◽  
Refractory Pain

Background: The cisterna Intrathecal Drug Delivery system (IDDS) with morphine has proven to be effective in treating refractory cancer pain above the middle thoracic vertebrae level in some countries. However, it has not been fully investigated in others. We designed the current project to investigate the efficacy and safety of cisterna IDDS for pain relief in refractory pain above the middle thoracic vertebrae level in advanced cancer patients. Methods: This study protocol allows for eligible cancer patients to receive the cisterna IDDS operation. Pain intensity (Visual Analogue scale, VAS), quality of life (36-Item Short-Form Health Survey, SF-36), and depression (Self-Rating Depression scale, SDS) are assessed along with side effects in the postoperative follow-up visits. Recent literature suggests a potential role for cisterna IDDS morphine delivery for refractory pain states above the middle thoracic level. Conclusion: The results of this study may provide further evidence that cisterna IDDS of morphine can serve as an effective and safe pain relief strategy for refractory pain above the middle thoracic vertebrae level in advanced cancer patients.

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