<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03759054</url>
  </required_header>
  <id_info>
    <org_study_id>Fase 1 patienter</org_study_id>
    <nct_id>NCT03759054</nct_id>
  </id_info>
  <brief_title>Cancer Patients in Clinical Trials and Their Relatives</brief_title>
  <official_title>Cancer Patients in Clinical Trials and Their Relatives</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aims&#xD;
&#xD;
      The aims of this study are:&#xD;
&#xD;
        1. To characterize patients' psychological well-being from the time they are referred to a&#xD;
           phase I trial and determine risk factors for poor well-being.&#xD;
&#xD;
        2. To investigate perceived information, expectations and regret when a patient participate&#xD;
           in a phase I trial.&#xD;
&#xD;
      Materials and methods This study is a prospective cohort study based on longitudinal applied&#xD;
      questionnaires.&#xD;
&#xD;
      The questionnaire will consist of questionnaires measuring stress, anxiety, depression and&#xD;
      health-related quality of life longitudinal through the course in the Phase I Unit. At the&#xD;
      time of inclusion in a trial, there will be questions regarding perceived information and&#xD;
      expectations. At the time of exclusion from trial, there will be questions regarding regret.&#xD;
&#xD;
      The questionnaire will consist primarily of validated questionnaires. When a validated&#xD;
      questionnaire does not exist, a previous applied questionnaire will be used to ensure&#xD;
      comparison with data from other studies. Only a limited use of self-constructed single-items&#xD;
      will be applied.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background The association between cancer and the occurrence of psychological disturbances&#xD;
      has been shown in several studies. For cancer patients participating in phase I trials,&#xD;
      psychological disturbances have also been found to be present, although with no comparison&#xD;
      group.&#xD;
&#xD;
      Relatives to patients in phase I trials are also found to have higher levels of perceived&#xD;
      stress and anxiety among 88 relatives compared to population norms measured with validated&#xD;
      instruments.&#xD;
&#xD;
      Recognizing the aim of a phase I trial as dose escalation was found among a minority of&#xD;
      patients (mean, 33%; range, 17-44%) in a systematic review. This review also found that a&#xD;
      mean of 62% (range, 22-92%) of patients expected personal benefit from the new drug and a&#xD;
      mean of 27% (range, 7-38%) expecting a cure for their cancer.&#xD;
&#xD;
      Regret has only been explored to a limited extent among patients in phase I trials and has&#xD;
      only been found among a minority.&#xD;
&#xD;
      Applied scales in the study&#xD;
&#xD;
        -  Psychological well-being will be measured with the Perceived Stress Scale (PSS), the&#xD;
           Generalized Anxiety Disorder (GAD7), and the Patient Health Questionnaire (PHQ-9).&#xD;
&#xD;
        -  Health-related quality of life will be measured with the EORTC Quality of Life&#xD;
           Questionnaire (QLQ-C30) for patients and the Short-Form Health Survey (SF-36) for&#xD;
           relatives.&#xD;
&#xD;
        -  Quality of Informed Consent (QuIC)&#xD;
&#xD;
        -  Expectations&#xD;
&#xD;
        -  Decision Regret Scale&#xD;
&#xD;
      Perspectives This study will contribute with a characterization of the psychological&#xD;
      well-being of patients referred to the Phase I Unit and possible factors of importance for&#xD;
      this, including the relatives' well-being. This knowledge can lead to a greater attention to&#xD;
      patients at risk of developing psychological disturbances and define challenges for&#xD;
      recruitment and maintenance in phase I trials.&#xD;
&#xD;
      The study will contribute to knowledge of patients' understanding of phase I trials and how&#xD;
      this can affect expectations and regret. Moreover, this study will be the first to&#xD;
      investigate if relatives' understanding of trial influences patients' perception of trial.&#xD;
      These findings are important for the evaluation the dialogue when information is given and to&#xD;
      considerations regarding involvement of relatives as possible resources for the patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2017</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Stress assessed by the Perceived Stress Scale, total score (range 0-40), higher score indicates a higher level of stress.</measure>
    <time_frame>First visit, at baseline visit, day 42 visit, through study completion, an average of 1 year</time_frame>
    <description>Among patients and relatives</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anixiety assessed by Generalized Anxiety Disorder scale, total score (range 0-21), higher score indicates a higher level of anxiety.</measure>
    <time_frame>First visit, at baseline visit, day 42 visit, through study completion, an average of 1 year</time_frame>
    <description>Among patients and relatives</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression assessed by Patient Health Questionnaire, total score (range 0-28), higher scoreindicates a higher level of depression.</measure>
    <time_frame>First visit, at baseline visit, day 42 visit, through study completion, an average of 1 year</time_frame>
    <description>Among patients and relatives</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>First visit, through study completion, an average of 1 year</time_frame>
    <description>Patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perceived information assessed by the QuIC, total score (range 0-100), higher score indicates a higher level of knowledge</measure>
    <time_frame>At baseline visit</time_frame>
    <description>Among patients and relatives</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regret assessed by Decision Regret Scale, total score (range 0-100), higher score indicates higher level of regret</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Among patients only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Question regarding motivations: How did you get to hear about the Phase 1 Unit? Descriptive distribution of answers.</measure>
    <time_frame>At baseline visit</time_frame>
    <description>Among patients only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Question regarding motivations: Indicate your reasons for participating in clinical trial treatment by circling the relevant number. Descriptive distribution of answers.</measure>
    <time_frame>At baseline visit</time_frame>
    <description>Among patients only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Question regarding expectations: During the clinical trial treatment do you expect your tumour(s) to … ? Descriptive distribution of answers.</measure>
    <time_frame>At baseline visit</time_frame>
    <description>Among patients only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Question regarding expectations: Do you expect the side effects of the clinical trial treatment to be … ? Descriptive distribution of answers.</measure>
    <time_frame>At baseline visit</time_frame>
    <description>Among patients only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>At baseline visit</time_frame>
    <description>Among patients only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Question regarding expectations: Would you like to participate in a phase 1 trial? Descriptive distribution of answers.</measure>
    <time_frame>At baseline visit</time_frame>
    <description>Among patients only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Question regarding expectations: Does your family or do your friends want you to participate in a phase 1 trial? Descriptive distribution of answers.</measure>
    <time_frame>At baseline visit</time_frame>
    <description>Among patients only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>At baseline visit</time_frame>
    <description>Among patients only</description>
  </secondary_outcome>
  <enrollment type="Actual">300</enrollment>
  <condition>Depression, Anxiety</condition>
  <condition>Information Disclosure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients and referred to the Phase I Unit at the Department of Oncology, Rigshospitalet,&#xD;
        and their closest relative will be invited to participate when they come for their first&#xD;
        information dialogue in the department. The questionnaire can be filled out immediately&#xD;
        after the dialogue if possible or filled out at home and sent or brought to the department&#xD;
        at next appointment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients referred to the Phase I Unit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who do not understand written Danish&#xD;
&#xD;
          -  patients for whom contact information is missing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulrik Lassen, MD</last_name>
    <role>Study Director</role>
    <affiliation>Head of Department of Oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 5, 2017</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Ulrik Lassen</investigator_full_name>
    <investigator_title>Head of Department of Oncology, professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03759054
org study id: Fase 1 patienter
nct id: NCT03759054
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
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
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.
time frame: 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.
time frame: First visit, at baseline visit, day 42 visit, through study completion, an average of 1 year
description: Among patients and relatives
measure: 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
description: Patients
measure: Perceived information assessed by the QuIC, total score (range 0-100), higher score indicates a higher level of knowledge
time frame: At baseline visit
description: Among patients and relatives
measure: 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
description: Among patients only
measure: Question regarding motivations: How did you get to hear about the Phase 1 Unit? Descriptive distribution of answers.
time frame: At baseline visit
description: Among patients only
measure: 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
description: Among patients only
measure: Question regarding expectations: During the clinical trial treatment do you expect your tumour(s) to … ? Descriptive distribution of answers.
time frame: At baseline visit
description: Among patients only
measure: 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
description: Among patients only
measure: 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
description: Among patients only
measure: Question regarding expectations: Would you like to participate in a phase 1 trial? Descriptive distribution of answers.
time frame: At baseline visit
description: Among patients only
measure: 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
description: Among patients only
measure: 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
description: Among patients only
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ulrik Lassen, MD
role: Study Director
affiliation: Head of Department of Oncology
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Ulrik Lassen
investigator title: Head of Department of Oncology, professor
mesh term: Depression
sharing ipd: No