ClinicalTrials.gov
ClinicalTrials.gov Menu

Cancer Patients in Clinical Trials and Their Relatives

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03759054
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Ulrik Lassen, Rigshospitalet, Denmark

Brief 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.


Condition or disease
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
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cancer Patients in Clinical Trials and Their Relatives
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. Perceived information assessed by the QuIC, total score (range 0-100), higher score indicates a higher level of knowledge [ Time Frame: At baseline visit ]
    Among patients and relatives

  2. 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 ]
    Among patients only

  3. Question regarding motivations: How did you get to hear about the Phase 1 Unit? Descriptive distribution of answers. [ Time Frame: At baseline visit ]
    Among patients only

  4. 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 ]
    Among patients only

  5. Question regarding expectations: During the clinical trial treatment do you expect your tumour(s) to … ? Descriptive distribution of answers. [ Time Frame: At baseline visit ]
    Among patients only

  6. 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 ]
    Among patients only

  7. 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 ]
    Among patients only

  8. Question regarding expectations: Would you like to participate in a phase 1 trial? Descriptive distribution of answers. [ Time Frame: At baseline visit ]
    Among patients only

  9. 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 ]
    Among patients only

  10. 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 ]
    Among patients only



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759054


Contacts
Contact: Ulrik Lassen, MD +4535458923 ulrik.lassen@regionh.dk
Contact: Katrine Gad, MD +4535450772 katrine.toubro.gad@regionh.dk

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Ulrik Lassen, MD         
Principal Investigator: Ulrik Lassen, MD, PH.D         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Director: Ulrik Lassen, MD Head of Department of Oncology

Responsible Party: Ulrik Lassen, Head of Department of Oncology, professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03759054     History of Changes
Other Study ID Numbers: Fase 1 patienter
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No