Aims

The aims of this study are:

1. To characterize patients' psychological well-being from the time they are referred to a phase I trial and determine risk factors for poor well-being.
2. To investigate perceived information, expectations and regret when a patient participate in a phase I trial.

Materials and methods This study is a prospective cohort study based on longitudinal applied questionnaires.

The questionnaire will consist of questionnaires measuring stress, anxiety, depression and health-related quality of life longitudinal through the course in the Phase I Unit. At the time of inclusion in a trial, there will be questions regarding perceived information and expectations. At the time of exclusion from trial, there will be questions regarding regret.

The questionnaire will consist primarily of validated questionnaires. When a validated questionnaire does not exist, a previous applied questionnaire will be used to ensure comparison with data from other studies. Only a limited use of self-constructed single-items will be applied.

Background The association between cancer and the occurrence of psychological disturbances has been shown in several studies. For cancer patients participating in phase I trials, psychological disturbances have also been found to be present, although with no comparison group.

Relatives to patients in phase I trials are also found to have higher levels of perceived stress and anxiety among 88 relatives compared to population norms measured with validated instruments.

Recognizing the aim of a phase I trial as dose escalation was found among a minority of patients (mean, 33%; range, 17-44%) in a systematic review. This review also found that a mean of 62% (range, 22-92%) of patients expected personal benefit from the new drug and a mean of 27% (range, 7-38%) expecting a cure for their cancer.

Regret has only been explored to a limited extent among patients in phase I trials and has only been found among a minority.

Applied scales in the study

• Psychological well-being will be measured with the Perceived Stress Scale (PSS), the Generalized Anxiety Disorder (GAD7), and the Patient Health Questionnaire (PHQ-9).
• Health-related quality of life will be measured with the EORTC Quality of Life Questionnaire (QLQ-C30) for patients and the Short-Form Health Survey (SF-36) for relatives.
• Quality of Informed Consent (QuIC)
• Expectations
• Decision Regret Scale

Perspectives This study will contribute with a characterization of the psychological well-being of patients referred to the Phase I Unit and possible factors of importance for this, including the relatives' well-being. This knowledge can lead to a greater attention to patients at risk of developing psychological disturbances and define challenges for recruitment and maintenance in phase I trials.

The study will contribute to knowledge of patients' understanding of phase I trials and how this can affect expectations and regret. Moreover, this study will be the first to investigate if relatives' understanding of trial influences patients' perception of trial. These findings are important for the evaluation the dialogue when information is given and to considerations regarding involvement of relatives as possible resources for the patients.

Inclusion Criteria:

• patients referred to the Phase I Unit

Exclusion Criteria:

• patients who do not understand written Danish
• patients for whom contact information is missing

Patients and referred to the Phase I Unit at the Department of Oncology, Rigshospitalet, and their closest relative will be invited to participate when they come for their first information dialogue in the department. The questionnaire can be filled out immediately after the dialogue if possible or filled out at home and sent or brought to the department at next appointment.