Improving the Quality of Abstract Reporting for Phase I Cancer Trials

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).

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Quality of life in patients with malignant melanoma participating in a phase I trial of an autologous tumour-derived vaccine

Melanoma Research ◽

10.1097/00008390-200209000-00013 ◽

2002 ◽

Vol 12 (5) ◽

pp. 505-511 ◽

Cited By ~ 16

Author(s):

L. Cohen ◽

P. A. Parker ◽

J. Sterner ◽

C. de Moor

Keyword(s):

Quality Of Life ◽

Malignant Melanoma ◽

Phase I ◽

Phase I Trial ◽

Autologous Tumour

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Morbidity and quality of life during thermotherapy using magnetic nanoparticles in locally recurrent prostate cancer: Results of a prospective phase I trial

International Journal of Hyperthermia ◽

10.1080/02656730601175479 ◽

2007 ◽

Vol 23 (3) ◽

pp. 315-323 ◽

Cited By ~ 213

Author(s):

M. Johannsen ◽

U. Gneveckow ◽

K. Taymoorian ◽

B. Thiesen ◽

N. Waldöfner ◽

...

Keyword(s):

Quality Of Life ◽

Prostate Cancer ◽

Magnetic Nanoparticles ◽

Phase I ◽

Phase I Trial ◽

Recurrent Prostate Cancer ◽

Prospective Phase ◽

Locally Recurrent

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Improving Phase I Monitoring of Dirichlet Regression Profiles

International Journal of Reliability Quality and Safety Engineering ◽

10.1142/s0218539318500304 ◽

2018 ◽

Vol 25 (06) ◽

pp. 1850030 ◽

Cited By ~ 1

Author(s):

Hourieh Foroutan ◽

Amirhossein Amiri ◽

Reza Kamranrad

Keyword(s):

Phase I ◽

Control Chart ◽

Control Charts ◽

Compositional Data ◽

Ratio Test ◽

Statistical Process ◽

Explanatory Variables ◽

Monitoring Procedure ◽

Multivariate Control

In most statistical process control (SPC) applications, quality of a process or product is monitored by univariate or multivariate control charts. However, sometimes a functional relationship between a response variable and one or more explanatory variables is established and monitored over time. This relationship is called “profile” in SPC literature. In this paper, we specifically consider processes with compositional data responses, including multivariate positive observations summing to one. The relationship between compositional data responses and explanatory variables is modeled by a Dirichlet regression profile. We develop a monitoring procedure based on likelihood ratio test (lrt) for Phase I monitoring of Dirichlet regression profiles. Then, we compare the performance of the proposed method with the best method in the literature in terms of probability of signal. The results of simulation studies show that the proposed control chart has better performance in Phase I monitoring than the competing control chart. Moreover, the proposed method is able to estimate the real time of a change as well. The performance of this feature is also investigated through simulation runs which show the satisfactory performance. Finally, the application of the proposed method is illustrated based on a real case in comparison with the existing method.

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Food allergy symptom self-management with technology (FASST): An mHealth intervention to address psychosocial outcomes in caregivers of children with newly diagnosed food allergy: Protocol for a pilot randomized controlled trial. (Preprint)

10.2196/preprints.25805 ◽

2020 ◽

Author(s):

Brantlee Broome ◽

Mohan Madisetti ◽

Margaret Prentice ◽

Kelli Wong Williams ◽

Teresa Kelechi

Keyword(s):

Randomized Controlled Trial ◽

Food Allergy ◽

Phase I ◽

Phase Ii ◽

Controlled Trial ◽

Self Management ◽

Newly Diagnosed ◽

Randomized Controlled ◽

Allergy Symptom

BACKGROUND Approximately 2.4 million children in the United States suffer from food-induced anaphylaxis; a condition that is annually responsible for over 200 deaths and 200,000 emergency room visits. As a result, caregivers of children newly diagnosed with severe and life-threatening food allergic reactions experience clinically significant symptoms of psychological distress, including: fatigue, anxiety, depressed mood, social isolation, and substantially reduced quality of life. Despite this recognition, there is a lack of caregiver-centered self-management interventions to address these concerns. OBJECTIVE In this protocol, we propose to develop and conduct feasibility testing of a technology-enhanced, self-management mHealth smartphone app intervention Food Allergy Symptom Self-Management with Technology for Caregivers (FASST) designed to meet the psychosocial health needs of caregivers of children with a new diagnosis of food allergy. METHODS This pilot study uses pre-formative qualitative work (Phase I) to inform a 4 -week longitudinal randomized controlled trial (Phase II). In Phase I, 10 caregivers of children (<18 years old) with established food allergy (diagnosed  1 year) will participate in semi-structured interviews to inform the development of the FASST app. In Phase II, 30 caregivers of children with a newly diagnosed food allergy (diagnosed  90 days) will be randomized 2:1 to receive FASST intervention (n = 20) or the control condition (basic app with educational resources) (n = 10). Process measures include feasibility, caregiver acceptability, adherence and satisfaction. Outcome measures include caregiver fatigue, anxiety, depression, sleep, self-efficacy, and quality of life mesasured at baseline,week 4, and at 3-months post study completion. RESULTS Pre-formative Phase I study activities have been completed and Phase II participant enrollment into the randomized controlled trial is expected to commence 2021. CONCLUSIONS With limited readily available resources at their disposal, the results from this study have the potential to provide caregivers of children with a newly diagnosed food allergy a tool to help them self-manage and mitigate negative psychosocial factors during a critical time-period in the caregiving/condition trajectory. CLINICALTRIAL ClinicalTrials.gov Identifier NCT04512924 (posted 08/14/2020).

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