Clinical trial · Observational
Cancer Patients in Clinical Trials and Their Relatives
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depression, Anxiety | — | UNRESOLVED | — |
| Information Disclosure | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Stress assessed by the Perceived Stress Scale, total score (range 0-40), higher score indicates a higher level of stress.
- timeFrame
- First visit, at baseline visit, day 42 visit, through study completion, an average of 1 year
- description
- Among patients and relatives
- measure
- Anixiety assessed by Generalized Anxiety Disorder scale, total score (range 0-21), higher score indicates a higher level of anxiety.
- timeFrame
- First visit, at baseline visit, day 42 visit, through study completion, an average of 1 year
- description
- Among patients and relatives
- measure
- Depression assessed by Patient Health Questionnaire, total score (range 0-28), higher scoreindicates a higher level of depression.
- timeFrame
- First visit, at baseline visit, day 42 visit, through study completion, an average of 1 year
- description
- Among patients and relatives
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available