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Cancer Patients in Clinical Trials and Their Relatives

NCT03759054 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2022-10-26

No results posted yet for this study

Summary

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.

Conditions

  • Depression, Anxiety
  • Information Disclosure

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Ulrik Lassen, MD · Head of Department of Oncology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03759054 on ClinicalTrials.gov