Depression, AnxietyNCT03759054
Cancer Patients in Clinical Trials and Their Relatives
An observational study of Depression, Anxiety and Information Disclosure, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Information Disclosure
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Apr 2017to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients referred to the Phase I Unit
Who cannot join
- patients who do not understand written Danish
- patients for whom contact information is missing
Trial locations and contacts
1 site in 1 country.
About this study
Aims
The aims of this study are:
Read more
- 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.
- 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.
Read the 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.
- Conditions
- Depression, Anxiety, Information Disclosure
- Medical subject headings
- Depression, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress assessed by the Perceived Stress Scale, total score (range 0-40), higher score indicates a higher level of stress.
Among patients and relatives
Measured: 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
Measured: 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
Measured: 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
Measured: First visit, through study completion, an average of 1 year
Secondary outcomes (10)
Perceived information assessed by the QuIC, total score (range 0-100), higher score indicates a higher level of knowledge
Among patients and relatives
Measured: At baseline visit
Regret assessed by Decision Regret Scale, total score (range 0-100), higher score indicates higher level of regret
Among patients only
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline visit
Question regarding expectations: Would you like to participate in a phase 1 trial? Descriptive distribution of answers.
Among patients only
Measured: 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
Measured: 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
Measured: At baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start10 Apr 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrik Lassen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ulrik Lassen, MD, Study director, Head of Department of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759054
- Sponsor's protocol ID
- Fase 1 patienter
- Status last verified
- Oct 2022
- First submitted
- 5 May 2017
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Patients in Clinical Trials and Their Relatives
- ClinicalTrials.gov ID
- NCT03759054
- Acronym / sponsor ID
- Fase 1 patienter
- Conditions
- Depression, Anxiety, Information Disclosure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims
The aims of this study are:
- 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.
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients referred to the Phase I Unit
Key exclusion criteria (2 listed)
- patients who do not understand written Danish
- patients for whom contact information is missing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stress assessed by the Perceived Stress Scale, total score (range 0-40), higher score indicates a higher level of stress.
Time frame: First visit, at baseline visit, day 42 visit, through study completion, an average of 1 year
Among patients and relatives
Anixiety assessed by Generalized Anxiety Disorder scale, total score (range 0-21), higher score indicates a higher level of anxiety.
Time frame: First visit, at baseline visit, day 42 visit, through study completion, an average of 1 year
Among patients and relatives
Depression assessed by Patient Health Questionnaire, total score (range 0-28), higher scoreindicates a higher level of depression.
Time frame: First visit, at baseline visit, day 42 visit, through study completion, an average of 1 year
Among patients and relatives
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.
Time frame: First visit, through study completion, an average of 1 year
Patients
10 secondary outcomes
Perceived information assessed by the QuIC, total score (range 0-100), higher score indicates a higher level of knowledge
Time frame: At baseline visit
Regret assessed by Decision Regret Scale, total score (range 0-100), higher score indicates higher level of regret
Time frame: 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.
Time frame: At baseline visit
Question regarding motivations: Indicate your reasons for participating in clinical trial treatment by circling the relevant number. Descriptive distribution of answers.
Time frame: At baseline visit
Question regarding expectations: During the clinical trial treatment do you expect your tumour(s) to … ? Descriptive distribution of answers.
Time frame: At baseline visit
Question regarding expectations: Do you expect the side effects of the clinical trial treatment to be … ? Descriptive distribution of answers.
Time frame: 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.
Time frame: At baseline visit
Question regarding expectations: Would you like to participate in a phase 1 trial? Descriptive distribution of answers.
Time frame: 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.
Time frame: 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.
Time frame: At baseline visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrik Lassen, MD study director
Head of Department of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Anxiety and Information Disclosure, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress assessed by the Perceived Stress Scale, total score (range 0-40), higher score indicates a higher level of stress. (time frame: First visit, at baseline visit, day 42 visit, through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.