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

Background: Psychological distress may be present among patients who are considering enrollment in phase 1 cancer trials, as they have advanced cancer and no documented treatment options remain. However, the prevalence of psychological distress has not been previously investigated in larger cohorts. In complex phase 1 cancer trials, it is important to ensure adequate understanding of the study premises, such as the undocumented effects and the risk of adverse events.

Socioeconomic Differences in Referral to Phase I Cancer Clinical Trials: A Danish Matched Cancer Case-Control Study.

Purpose: In this nationwide registry study, we investigated socioeconomic and structural patterns in referral to phase I cancer trials in a case-control study design.

Methods: Personal identification numbers on all Danish patients referred to the Danish Phase I Unit at Rigshospitalet from 2005 to 2016, and a control group matched on age, sex, type of cancer, year of diagnosis, and time from diagnosis to referral ensured individual-level linkage between several registries. We examined the association between nonclinical factors-indicators of socioeconomic position and distance to the Phase I Unit-and referral using a conditional logistic regression analysis adjusted for several clinical factors.

Patient information in phase 1 trials: A systematic review.

Objective: To review what is known about cancer patients' decisions to enter a phase 1 trial and how they and their relatives perceive the information they receive when they are invited to participate.

Methods: This systematic review is based on the principles of "preferred reporting items for systematic reviews and meta-analyses." A systematic search was performed in the PubMed, Embase, and PsycInfo databases, supplemented by a search for unpublished literature.