Patients in phase 1 cancer trials: psychological distress and understanding of trial information

Abstract Background Studies of psychological distress in Sierra Leone have typically used measures which were developed for use in other contexts, and which often have not been adapted or validated for use in Sierra Leone. This has resulted in a lack of reliable information about the patterns of psychological distress within the population, which is a barrier to the development of effective and appropriate mental health services. The aim of the study was to develop a locally-appropriate measure of psychological distress for Sierra Leone. Methods The new measure consists of two instruments: the Sierra Leone Psychological Distress Scale (SLPDS) and a gendered measure of ability to carry out daily tasks—a Function scale—as an indication of the severity of distress. A three-phase mixed methods exploratory sequential study was conducted. Phase 1 was item generation and testing, leading to the development of a set of potential items for both instruments. Phase 2 was a small pilot study (N = 202) leading to the selection of the final set of items for both measures. Phase 3 was a validation phase where the SLPDS and the Function scale were administered with a larger sample of 904 respondents. Item analysis was used to assess the internal consistency of the scales, and Exploratory Factor Analysis to explore the properties of the SLPDS. Results Exploratory factor analysis using the principal axis factoring with an oblique rotation identified a three-factor structure for the 18-item SLPDS. Internal consistency for the SLPDS (Cronbach’s alpha = 0.89) and three subscales was good (Cronbach’s alpha > 0.73). The internal reliability of the male and female versions of the Function scale was also found to be acceptable (Cronbach’s alpha = 0.90 for the female scale and 0.79 for the male scale). Conclusions Together the SLPD and Function scales provide a locally-validated tool which will enable government bodies and local and international non-governmental organisations in Sierra Leone to assess mental health and psychosocial needs. This will support both effective service provision and the evaluation of initiatives designed to improve mental health and psychosocial wellbeing.

Download Full-text

Abstract PD4-02: Canadian cancer trials group trial IND.231: A phase 1 trial evaluating CX-5461, a novel first-in-class G-quadruplex stabilizer in patients with advanced solid tumors enriched for DNA-repair deficiencies

10.1158/1538-7445.sabcs19-pd4-02 ◽

2020 ◽

Author(s):

John Hilton ◽

Karen Gelmon ◽

David Cescon ◽

Anna Tinker ◽

Derek Jonker ◽

...

Keyword(s):

Dna Repair ◽

Solid Tumors ◽

Phase 1 ◽

Advanced Solid Tumors ◽

Phase 1 Trial ◽

G Quadruplex ◽

Cancer Trials ◽

Group Trial

Download Full-text

Ethical Review and Methodologic Innovation in Phase 1 Cancer Trials

JAMA Pediatrics ◽

10.1001/jamapediatrics.2019.0811 ◽

2019 ◽

Vol 173 (6) ◽

pp. 609 ◽

Cited By ~ 1

Author(s):

David C. Norris

Keyword(s):

Phase 1 ◽

Ethical Review ◽

Cancer Trials

Download Full-text

Participant Protection in Phase 1 Pediatric Cancer Trials

JAMA Pediatrics ◽

10.1001/jamapediatrics.2018.3629 ◽

2019 ◽

Vol 173 (1) ◽

pp. 8 ◽

Cited By ~ 2

Author(s):

Jonathan Kimmelman ◽

Marcin Waligora ◽

Holly Fernandez Lynch

Keyword(s):

Pediatric Cancer ◽

Phase 1 ◽

Cancer Trials

Download Full-text

Voices of children and adolescents on phase 1 or phase 2 cancer trials: A new trial endpoint?

Cancer ◽

10.1002/cncr.30782 ◽

2017 ◽

Vol 123 (19) ◽

pp. 3799-3806 ◽

Cited By ~ 7

Author(s):

Pamela S. Hinds ◽

Jichuan Wang ◽

Emily Dunn Stern ◽

Catherine Fiona Macpherson ◽

Claire M. Wharton ◽

...

Keyword(s):

Children And Adolescents ◽

Phase 1 ◽

Phase 2 ◽

Cancer Trials ◽

Trial Endpoint

Download Full-text

Ethical Review and Methodologic Innovation in Phase 1 Cancer Trials—Reply

JAMA Pediatrics ◽

10.1001/jamapediatrics.2019.0797 ◽

2019 ◽

Vol 173 (6) ◽

pp. 609

Author(s):

Jonathan Kimmelman ◽

Marcin Waligora ◽

Holly Fernandez Lynch

Keyword(s):

Phase 1 ◽

Ethical Review ◽

Cancer Trials

Download Full-text

Informed consent for pediatric phase 1 cancer trials: Physicians' perspectives

Cancer ◽

10.1002/cncr.25158 ◽

2010 ◽

Vol 116 (13) ◽

pp. 3244-3250 ◽

Cited By ~ 29

Author(s):

Tsiao Yi Yap ◽

Amy D. Yamokoski ◽

Sabahat Hizlan ◽

Stephen J. Zyzanski ◽

Anne L. Angiolillo ◽

...

Keyword(s):

Informed Consent ◽

Phase 1 ◽

Cancer Trials

Download Full-text

Toxicity disparities between Hispanics and non-Hispanics enrolled in clinical trials in south Texas.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e18089 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e18089-e18089

Author(s):

Ojas Harihar Vyas ◽

Marcela Mazo- Canola ◽

Juan Francisco Garza ◽

Ruchi Hamal ◽

Lashandra Royster ◽

...

Keyword(s):

Clinical Trials ◽

Early Phase ◽

Phase 1 ◽

South Texas ◽

Academic Center ◽

History Of ◽

Multiple Trials ◽

Cancer Trials ◽

Grade 3 ◽

Early Phase Clinical Trials

e18089 Background: The U.S. Hispanic (H) population is estimated to increase from 55 million in 2014 to 119 million in 2060, growing from 17% to 29% of the total population. H are underrepresented in cancer trials. A review of practice-changing oncology trials showed only 3.9% of included patients were H. Disparities have been identified in time to diagnosis, treatment and outcomes in H patients, including those on clinical trials, despite uniform stage, treatment, and follow-up. Given our institution’s history of strong H accrual, we aimed to look at the rate of enrollment and toxicity in our early phase cancer trials of H compared with non-Hispanic whites (NHW). Methods: We retrospectively reviewed charts of patients enrolled in Phase I trials at UTHSCSA to assess rates of selected toxicities, death, hospitalizations and reasons for withdrawal from phase 1 trials. The following toxicities were recorded: anemia, neutropenia, neuropathy, nausea, vomiting, and fatigue. All H patients were compared to randomly selected statistical controls. Patients who were on multiple trials were excluded. Results: Of the 520 patients reviewed, 376 (72.3%) self-identified as H, 123(23.7%) as NHW, and 448 (86.2%) of patients had a solid tumor diagnosis. H and NHW with solid tumors are compared in the Table. They were similarly matched for sex, but H were noted to be older and more likely to receive cytotoxic therapy. Rates of patients experiencing any grade 3/4 toxicity or hospitalization were similar as shown. H were more likely to withdraw from trial due to disease progression. Conclusions: This retrospective analysis shows H patients did not experience significantly more toxicities in early phase clinical trials at an academic center in a minority-majority community. Prospective data collection is needed to provide more detailed information in the disparities that exist in toxicity and outcomes in H compared with NHW in cancer trials. [Table: see text]

Download Full-text

Comprehensively assessing the clinical trial landscape in oncology over the last 10 years.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e18023 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e18023-e18023

Author(s):

Jonathan Crowther ◽

David john Cocker

Keyword(s):

Clinical Trial ◽

Adaptive Design ◽

Phase 1 ◽

Research Field ◽

Multiple Drug ◽

Clinical Activity ◽

Real World Data ◽

Drug Databases ◽

Cancer Trials ◽

Semantic Ontology

e18023 Background: Since the establishment of clinical trial registries such as ClinicalTrials.gov the number of such registries and the volume of data within the registries has quadrupled. Many studies have assessed the clinical trial landscape within their research field and have been hindered by inadequate search queries. Several approaches within these studies have implemented descriptive statistical analysis by examining specific indications or by searching for trials often using vague search terms such as “neoplasms”. This type of analysis permits the integration of potentially non-relevant noisy data which, impairs the overall analysis quality, Methods: In this study, we developed a semantic ontology linking algorithm to comprehensively merge 16 trial registries, 198,000 clinical trials, 10,000 molecules from multiple drug databases and PubMed, thus rendering and identifying indications, treatment, sites and investigators into one resource. The method allowed for a semantically cleaned and collapsed database to be queried more effectively with higher reliability in results. Results: The second proponent of our study was to assess the international oncology trial landscape over the last 10 years. The last major analysis in 2009 identified a significant preference for United States clinical sites in large cancer trials. Since this study, oncology has evolved toward a precision therapy approach and adaptive design model. This 2017 analysis shows an increasing concentration of US based clinical activity. For lung cancer trials with a US component, the top 100 US clinical research sites in the US are involved in 86% of the phase 1 trials, representing 55% of the total enrolment. When analyzing site usage for phase 3, this share drops to 67% of trials, representing just 8,5% of the total patient enrolment targets. Conclusions: The semantic ontology and algorithms and exploiting real-world data to mapped out and re-evaluate the status of cancer trials globally and gave insights into how cancer trials are progressing in the future. Understanding this evolution is of high importance for clinical trial planning and global trial country and site optimization.

Download Full-text