Cancer Patients in Clinical Trials and Their Relatives

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.

Study Overview

• Status: Completed
• Conditions: Depression, Anxiety; Information Disclosure

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress assessed by the Perceived Stress Scale, total score (range 0-40), higher score indicates a higher level of stress.	Among patients and relatives	First visit, at baseline visit, day 42 visit, through study completion, an average of 1 year
Anixiety assessed by Generalized Anxiety Disorder scale, total score (range 0-21), higher score indicates a higher level of anxiety.	Among patients and relatives	First visit, at baseline visit, day 42 visit, through study completion, an average of 1 year
Depression assessed by Patient Health Questionnaire, total score (range 0-28), higher scoreindicates a higher level of depression.	Among patients and relatives	First visit, at baseline visit, day 42 visit, through study completion, an average of 1 year
Physical functioning assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, subscale physical functioning, score (range 0-100), higher score indicates better physical functioning.	Patients	First visit, through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived information assessed by the QuIC, total score (range 0-100), higher score indicates a higher level of knowledge	Among patients and relatives	At baseline visit
Regret assessed by Decision Regret Scale, total score (range 0-100), higher score indicates higher level of regret	Among patients only	through study completion, an average of 1 year
Question regarding motivations: How did you get to hear about the Phase 1 Unit? Descriptive distribution of answers.	Among patients only	At baseline visit
Question regarding motivations: Indicate your reasons for participating in clinical trial treatment by circling the relevant number. Descriptive distribution of answers.	Among patients only	At baseline visit
Question regarding expectations: During the clinical trial treatment do you expect your tumour(s) to … ? Descriptive distribution of answers.	Among patients only	At baseline visit
Question regarding expectations: Do you expect the side effects of the clinical trial treatment to be … ? Descriptive distribution of answers.	Among patients only	At baseline visit
Question regarding expectations: If you have received chemo treatment previously, how do you expect the side effects of the clinical trial treatment will be? Descriptive distribution of answers.	Among patients only	At baseline visit
Question regarding expectations: Would you like to participate in a phase 1 trial? Descriptive distribution of answers.	Among patients only	At baseline visit
Question regarding expectations: Does your family or do your friends want you to participate in a phase 1 trial? Descriptive distribution of answers.	Among patients only	At baseline visit
Question regarding expectations: I expect: That my physically health will improve/That my mental health will improve/That my life from a social aspect will improve/That I will prolong my life/That I will be cured. Descriptive distribution of answers.	Among patients only	At baseline visit

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Study Director: Ulrik Lassen, MD, Head of Department of Oncology

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 10, 2017
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (ACTUAL): November 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: Fase 1 patienter

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No