Impact of informed consent quality on illness uncertainty among patients with cancer in clinical trials: A cross-sectional study

Abstract

Objective

This study aimed to examine the level of illness uncertainty and the quality of informed consent among patients with cancer participating in clinical trials and explore their interrelationship.

Methods

A cross-sectional study was conducted with 265 patients with cancer recruited from a tertiary hospital in Beijing, China, from April to November 2023. Participants completed a questionnaire encompassing demographic details, the Mishel Uncertainty in Illness Scale, and the Quality of Informed Consent Questionnaire. Descriptive statistics, correlation analyses, and multiple regression analyses were performed to assess the data.

Results

The mean illness uncertainty score was 40.63 ​± ​10.12, reflecting a moderately low level of uncertainty, with “Ambiguity” scoring the highest among its dimensions. The mean score for informed consent quality was 3.30 ​± ​1.20, indicating a moderate level of understanding, with notable gaps in elements such as alternatives and confidentiality. A significant negative correlation was found between the “Foreseeable risks or discomforts” element of informed consent and overall illness uncertainty (P ​< ​0.05). Regression analysis revealed that factors such as clinical trial phase, primary caregiver relationship, and health insurance model significantly influenced illness uncertainty and its dimensions.

Conclusions

Enhancing the quality of informed consent can effectively reduce illness uncertainty among patients with cancer in clinical trials. Greater emphasis should be placed on clear communication of risks and discomforts and patient-centered interventions to mitigate psychological stress.