scholarly journals Keeping Connected With School: Implementing Telepresence Robots to Improve the Wellbeing of Adolescent Cancer Patients

2021 ◽  
Vol 12 ◽  
Author(s):  
Thomasin Powell ◽  
Jennifer Cohen ◽  
Pandora Patterson
Keyword(s):  
Phase I ◽  
Cancer Patients ◽  
Phase Ii ◽  
Social Needs ◽  
Structured Interviews ◽  
Adolescent Cancer ◽  
Telepresence Robot ◽  
Acceptable Method ◽  
Telepresence Robots ◽  
Key Aspects

Background: Adolescent cancer patients experience considerable absence from their education, contributing to poorer academic attainment and isolation from peers, and impacting wellbeing. Telepresence robots have been used to support the educational and social needs of young people with chronic illness. This article presents the results of the development and pilot-testing of a telepresence robot service in schools for adolescent cancer patients – the TRECA (Telepresence Robots to Engage CAncer patients in education) service.Methods: Phase I used semi-structured interviews (n = 25) to assess the views of patients, parents, schools and clinicians on the benefits, acceptability, barriers, and enablers of utilizing robots in schools for adolescent cancer patients. Results from Phase I informed the development of the TRECA service. Phase II used semi-structured interviews (n = 22) to assess the implementation experiences of adolescent cancer patients, and their families, schools, and keyworkers who pilot-tested the TRECA service.Results: Phase I demonstrated the need for telepresence technology in connecting adolescent cancer patients to school. Given the variable support during treatment, a telepresence robot service was considered an acceptable method of facilitating a school-patient connection. The recommendations provided in Phase I, such as the need for provision of ongoing education, training, and support to the patient and school, informed the development of the TRECA service. In Phase II, the themes of The necessity of stakeholder buy-in, A facilitator of meaningful connection, and One size does not fit all were generated. The TRECA service’s flexibility in meeting the needs of its users helped facilitate meaningful connections. Participants reported that these connections provided patients an enhanced sense of agency and wellbeing. The importance of stakeholder buy-in and taking an individualized approach to service delivery were also highlighted. Stakeholder miscommunication and lack of knowledge were key aspects of implementation needing improvement as the service is rolled out on a larger scale.Conclusion: Using telepresence robots to connect adolescents to school during cancer treatment was regarded as highly acceptable, facilitating peer and academic connection. By making stakeholder-recommended improvements to the TRECA service’s existing processes, the service will continue to grow in effectiveness and capacity.

scholarly journals Unconventional Anticancer Agents: A Systematic Review of Clinical Trials

2006 ◽  
Vol 24 (1) ◽  
pp. 136-140 ◽  
Author(s):  
Andrew J. Vickers ◽  
Joyce Kuo ◽  
Barrie R. Cassileth
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Phase Ii ◽  
Dose Finding ◽  
Phase Iii ◽  
High Dose ◽  
Free Text ◽  
Phase Ii Trials ◽  
Off Label

Purpose A substantial number of cancer patients turn to treatments other than those recommended by mainstream oncologists in an effort to sustain tumor remission or halt the spread of cancer. These unconventional approaches include botanicals, high-dose nutritional supplementation, off-label pharmaceuticals, and animal products. The objective of this study was to review systematically the methodologies applied in clinical trials of unconventional treatments specifically for cancer. Methods MEDLINE 1966 to 2005 was searched using approximately 200 different medical subject heading terms (eg, alternative medicine) and free text words (eg, laetrile). We sought prospective clinical trials of unconventional treatments in cancer patients, excluding studies with only symptom control or nonclinical (eg, immune) end points. Trial data were extracted by two reviewers using a standardized protocol. Results We identified 14,735 articles, of which 214, describing 198 different clinical trials, were included. Twenty trials were phase I, three were phase I and II, 70 were phase II, and 105 were phase III. Approximately half of the trials investigated fungal products, 20% investigated other botanicals, 10% investigated vitamins and supplements, and 10% investigated off-label pharmaceuticals. Only eight of the phase I trials were dose-finding trials, and a mere 20% of phase II trials reported a statistical design. Of the 27 different agents tested in phase III, only one agent had a prior dose-finding trial, and only for three agents was the definitive study initiated after the publication of phase II data. Conclusion Unconventional cancer treatments have not been subject to appropriate early-phase trial development. Future research on unconventional therapies should involve dose-finding and phase II studies to determine the suitability of definitive trials.

scholarly journals Mixed methods study protocol to examine perceptions of family medicine among long-term patients of a family medicine clinic in Japan

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e037113
Author(s):  
Kotaro Sato ◽  
Ryoko Michinobu ◽  
Tesshu Kusaba
Keyword(s):  
Primary Care ◽  
Mixed Methods ◽  
Family Medicine ◽  
Phase I ◽  
Phase Ii ◽  
Medical Specialty ◽  
Structured Interviews ◽  
Two Phase ◽  
Care Systems

IntroductionFamily physicians or general practitioners play central roles in many countries’ primary care systems, but family medicine (FM) remains relatively unestablished in Japan. Previous studies in Japan have examined the general population’s understanding of FM as a medical specialty, but none have explored this topic using actual FM clinic patients. Here, we describe a protocol to explore the perceptions of FM among long-term patients of one of Japan’s oldest FM clinics.Methods and analysisThe study will be conducted at the Motowanishi Family Clinic in Hokkaido, Japan, using patients who have attended the clinic for over 10 years. The analysis will adopt a two-phase explanatory sequential mixed methods design. During phase I, quantitative data from participants’ medical records will be collected and reviewed, and patients’ perceptions of FM will be assessed through a questionnaire. The correlations between participants’ knowledge that the clinic specialises in FM and various characteristics will be examined. In phase II, qualitative data will be collected through semi-structured interviews of approximately 10 participants selected using maximum variation sampling based on phase I results. A thematic analysis will be conducted in phase II to identify patients’ perceptions and changes in perceptions. Finally, each theme identified in phase II will be transformed into a quantitative variable to analyse the relationships between the phases. A joint display will be used to integrate the phases’ findings and examine how phase II results explain phase I results.Ethics and disseminationThe institutional review board of the Japan Primary Care Association has approved this research (2019-003). The results will be presented at the association’s annual academic meeting and submitted for publication in relevant journals. The findings will also be provided to the patients via the clinic’s internal newsletter.

Identifying Criteria for Continuous Evaluation of Software Engineers for Reward and Recognition

2016 ◽  
Vol 7 (4) ◽  
pp. 61-78 ◽  
Author(s):  
Sreejith S. S. ◽  
Muthu Mathirajan
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Employee Performance ◽  
Exploratory Research ◽  
Structured Interviews ◽  
Continuous Evaluation ◽  
Software Engineers ◽  
Two Phases ◽  
R Process ◽  
Reward And Recognition

Reward and Recognition (R&R) should be given to employees in a timely manner, based on continuous evaluation of their performance. Success of an R&R process lies in clear and well defined criteria for continuous evaluation of employee performance. Often such criteria are decided by the organization with no input from the employees. The purpose of this paper is to use qualitative research methods to explore and identify the criteria to be used for continuous employee performance evaluation for R&R in Information Technology organizations, from the perspectives of software engineers (SEs) and project managers (PMs). Exploratory research was conducted in two phases. In Phase I, unstructured interviews are used to elicit information from 7 SEs. Caselets are prepared based on these interviews and 19 criteria are identified. In Phase II, the criteria identified in Phase I are confirmed using content analysis of semi-structured interviews, conducted on relatively larger group of SEs (in stage 1) and PMs (in stage 2). Additionally, 12 criteria are also identified in Phase II. Collectively 31 criteria are identified. The proposed criteria set is expected to comprehensively cover the SE performance on a continuous basis in various dimensions to award R&R.

Evaluation of statistical designs of phase I/II clinical trials for cancer patients published in 2005

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 14077-14077
Author(s):  
N. Houede ◽  
A. Kramar ◽  
X. Paoletti
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Phase Ii ◽  
Dose Escalation ◽  
Objective Response ◽  
Biological Marker ◽  
Statistical Design ◽  
Phase Ii Trials ◽  
Dose Levels

14077 Background: Phase I trials determine the maximal safe dose that could be used in phase II trials. Designs are based on the assumption that efficacy and toxicity increase with dose. Phase I/II trials determine the safety, dosage levels, and response rate. This review addresses statistical issues of phase I/II studies designs. Methods: We reviewed phase I/II clinical trials for cancer patients published in 2005. The main criteria were: type of treatment, statistical design, endpoints, expected efficacy and toxicity, one- or two-steps designs, dose levels, definition of Dose Limiting Toxicity and recommended dose, objective response, survival, patient selection and follow-up. Results: 41 phase I/II trials were found. All but one, targeted a specific type of tumor. 14 studies included combined cytotoxic therapies. 21 studies included a cytotoxic agent combined with a targeted therapy (12) or with radiations (9). Others used monochemotherapy, immunotherapy, vaccine or gene therapy. 23 studies were a two steps design, i.e. a phase I followed by a phase II trial, and used a classical Fibonacci escalation dose model. All others used a one-step design evaluating efficacy and toxicity concomitantly. Among them, 3 had a Fibonacci-like design with a desescalation model and 4 had a randomization to different dose levels. In 1 trial, dose escalation was performed in the same patient. In the 10 remaining studies, 1 evaluated only one dose level and was improperly presented as a phase I/II study, and 9 did not describe any statistical design. DLT was described in only 27 trials. Also, recommended doses for further trials were only provided in 30 studies. Efficacy was evaluated with clinical or radiological response for 34 studies, biological marker was evaluated in 5 cases and time to progression in 2 cases. Conclusion: Most of the phase I/II trials published in 2005 used a classical two steps design with an adapted Fibonacci dose escalation. None of them used new designs such as continual reassessment method (CRM), which have the advantage to incorporate data during the course of the trial, leading to optimization of the study in terms of cost and speed. Methodological progresses are necessary to address issues related to multiple endpoints and to help clinicians to feel comfortable with the CRM. No significant financial relationships to disclose.

scholarly journals Efficacy and Safety of the All-Oral Schedule of Metronomic Vinorelbine and Capecitabine in Locally Advanced or Metastatic Breast Cancer Patients: The Phase I-II VICTOR-1 Study

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
M. E. Cazzaniga ◽  
V. Torri ◽  
F. Villa ◽  
N. Giuntini ◽  
F. Riva ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Cancer Patients ◽  
Phase Ii ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
Fixed Dose ◽  
Toxicity Profile ◽  
Breast Cancer Patients

Background. Vinorelbine (VRB) and capecitabine (CAPE) are demonstrated to be active in pretreated metastatic breast cancer patients. Different studies have demonstrated that the metronomic treatment is active with an acceptable toxicity profile. We designed a Phases I-II study to define the MTD of oral metronomic, VRB, and CAPE.Patients and Methods. Phase I: fixed dose of CAPE was 500 mg thrice a day, continuously. Level I of VRB was 20 mg/tot thrice a week for 3 weeks (1 cycle). Subsequent levels were 30 mg/tot and 40 mg/tot (Level III), respectively, if no Grades 3-4 toxicity were observed in the previous level. Phase II: further 32 patients received the MTD of VRB plus CAPE for a total of 187 cycles to confirm toxicity profile.Results. 12 patients were enrolled in Phase I and 22 in Phase II. Phase I: the MTD of VRB was 40 mg. Phase II: 187 cycles were delivered, observing 5.9% of Grades 3-4 toxicity. 31 patients are evaluable for efficacy, obtaining a clinical benefit rate of 58.1%.Conclusion. MTD of VRB with fixed dose of CAPE was 40 mg thrice a week and was the recommended dose for the ongoing Phase II multicenter study.

Phase I/II trial combining the HDAC inhibitor, valproic acid (VPA) and FEC100 (5-fluorouracil, epirubicin and cyclophosphamide) in locally advanced/metastatic breast cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1065-1065 ◽  
Author(s):  
P. N. Munster ◽  
D. C. Marchion ◽  
M. Schmitt ◽  
E. Bicaku ◽  
M. Lacevic ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Phase I ◽  
Histone Acetylation ◽  
Cancer Patients ◽  
Phase Ii ◽  
Stable Disease ◽  
Locally Advanced ◽  
Breast Cancer Patients ◽  
Minor Response ◽  
Tumor Types

1065 Background: Cell culture and xenograft studies suggest a synergistic interaction between histone deacetylase inhibitors (HDACi) and topoisomerase (topo) inhibitors, as well as other DNA targeting agents. Methods: In this phase I/II study, we determined the effects of escalating doses of VPA on the clinical efficacy and tolerability of epirubicin. The phase I part was open to patients will all solid tumors. A limited phase II part at the maximum tolerated dose (MTD) of VPA enrolled 10 breast cancer patients and incorporated the breast cancer regimen FEC100 (5-fluorouracil, epirubicin, cyclophosphamide (600/100/600 mg/m2)). VPA was given on days 1–3 prior to epirubicin/FEC100 in 3-week cycles. HDAC expression, histone acetylation and topo II expression were evaluated in pre-and post-VPA peripheral blood mononuclear cells and tumor samples. Results: Fifty-four (44 in phase I and 10 in phase II) patients [median age 55 (39–78)] received VPA (mg/kg/day): 15, 30, 45, 60, 75, 90, 100, 120, 140 and 160. Tumor types included: breast (10+10), melanoma (11), lung (6), sarcoma (2), GYN (2), GI (5) and others (8). Dose-limiting toxicities included somnolence, confusion and febrile neutropenia. No exacerbation of FEC100/epirubicin-related toxicities was observed. Objective responses in the phase I part 9/41 (22%) were seen across different tumor types despite a median number of 3 (0–6) prior regimens with stable disease/minor response in 16/41 (39%). In the breast-specific phase II part, partial responses to date were seen in 4/8 (50%) and stable disease in 2/8 (25%), progression in 1/8 (12.5%), 1/8 (12.5%) patients withdrew consent. All breast cancer patients with a response/stable disease received the maximal number of seven cycles. VPA plasma concentrations correlated with VPA dose. There was a positive correlation between histone acetylation and VPA dose as well as plasma levels in PBMC and further correlated with those in tumors. Conclusion: A sequence-specific combination of VPA and FEC100 in breast cancer is highly active without exacerbation of chemotherapy-induced toxicities. A neoadjuvant phase II trial using VPA (120 mg/kg) -> FEC100 in patients with early stage breast cancer is ongoing. [Table: see text]

Bewegungstherapie und körperliche Aktivität bei Patienten mit Herzinsuffizienz

Praxis ◽  
2018 ◽  
Vol 107 (17-18) ◽  
pp. 951-958 ◽  
Author(s):  
Matthias Wilhelm
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Körperliche Aktivität ◽  
Phase Iii

Zusammenfassung. Herzinsuffizienz ist ein klinisches Syndrom mit unterschiedlichen Ätiologien und Phänotypen. Die überwachte Bewegungstherapie und individuelle körperliche Aktivität ist bei allen Formen eine Klasse-IA-Empfehlung in aktuellen Leitlinien. Eine Bewegungstherapie kann unmittelbar nach Stabilisierung einer akuten Herzinsuffizienz im Spital begonnen werden (Phase I). Sie kann nach Entlassung in einem stationären oder ambulanten Präventions- und Rehabilitationsprogramm fortgesetzt werden (Phase II). Typische Elemente sind Ausdauer-, Kraft- und Atemtraining. Die Kosten werden von der Krankenversicherung für drei bis sechs Monate übernommen. In erfahrenen Zentren können auch Patienten mit implantierten Defibrillatoren oder linksventrikulären Unterstützungssystemen trainieren. Wichtiges Ziel der Phase II ist neben muskulärer Rekonditionierung auch die Steigerung der Gesundheitskompetenz, um die Langzeit-Adhärenz bezüglich körperlicher Aktivität zu verbessern. In Phase III bieten Herzgruppen Unterstützung.

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