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E-Health Portal for Individualized Treatment Monitoring and Patient Engagement in Oncology Research

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ClinicalTrials.gov Identifier: NCT03132506
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : February 11, 2020
Sponsor:
Collaborators:
National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Germany
Department of Gynecology and Obstetrics, University Hospital Heidelberg, Germany
Department of Gynecology and Obstetrics, University Hospital Erlangen, Germany
Information provided by (Responsible Party):
University Women's Hospital Tübingen

Brief Summary:
Evaluation of patient acceptance and characterization of response behaviour for web-based compared with respective paperbacked patient reported outcomes.

Condition or disease Intervention/treatment
Breast Cancer Metastatic Other: patient-reported-outcomes

Detailed Description:

Paperbacked pPRO data from up to a total of 100 patients from the cohort of PRAEGNANT are planned to be included in the Pepper I PRO study. Additionally 200 patients will be recruited in the web based ePRO cohort. The study duration per patient is at least 8 weeks. In cases of stable disease the study duration can be extended to up to 6 months with monthly PRO assessments, according to the attached visit matrix, taking approximately 20 minutes per visit.

The documentation at baseline should be performed during clinical routine with trained study personnel followed by remote self-reporting to minimize the patient effort. Pepper I will be conducted as sub-protocol of the PRAEGNANT trial.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: E-Health Portal for Individualized Treatment Monitoring and Patient Engagement in Oncology Research Focused on Capture of Patient Reported Outcomes With Within PRAEGNANT Study Network
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
paper-based patient-reported-outcomes Other: patient-reported-outcomes
Explorative pilot study combining collected data from the PRAEGNANT study on paper-based patient-reported-outcomes with additional collected data on web-based patient-reported-outcomes

on web-based patient-reported-outcomes Other: patient-reported-outcomes
Explorative pilot study combining collected data from the PRAEGNANT study on paper-based patient-reported-outcomes with additional collected data on web-based patient-reported-outcomes




Primary Outcome Measures :
  1. QLQ-C30 questionnaire for baseline [ Time Frame: 8 weeks ]
    Overall patient completion rate in the paperbacked questionnaire and the web-tool, respectively


Secondary Outcome Measures :
  1. All other questionnaires for baseline and follow up time points. [ Time Frame: Baseline, 8 weeks ]
    Overall patient completion rate in the paperbacked questionnaire and the web-tool, respectively,

  2. Influence factors for the completion rates [ Time Frame: 8 weeks ]
    age

  3. Influence factors for the completion rates [ Time Frame: 8 weeks ]
    line of treatment

  4. Influence factors for the completion rates [ Time Frame: 8 weeks ]
    treatment

  5. Influence factors for the completion rates [ Time Frame: 8 weeks ]
    technical skills

  6. Influence factors for the completion rates [ Time Frame: 8 weeks ]
    patient's satisfaction

  7. Adverse events-1 [ Time Frame: 8 weeks ]
    The date of clinical diagnosis of AE compared with the date of early AE onset

  8. Adverse events-2 [ Time Frame: 8 weeks ]
    Consistency of AE documentation ePRO and clinician based

  9. Patient satisfaction [ Time Frame: baseline, 4 weeks, 8 weeks ]
    at baseline, after 4 weeks and after 8 weeks

  10. Health related quality of life (HRQL) assessements -1 [ Time Frame: baseline, 4 weeks, 8 weeks ]
    EORTC QLQ C-30

  11. Health related quality of life (HRQL) assessements -1 [ Time Frame: baseline, 4 weeks, 8 weeks ]
    BR23

  12. Health related quality of life (HRQL) assessements -1 [ Time Frame: baseline, 4 weeks, 8 weeks ]
    NCCN distress thermometer,

  13. Health related quality of life (HRQL) assessements -1 [ Time Frame: baseline, 4 weeks, 8 weeks ]
    EQ-VAS

  14. Health related quality of life (HRQL) assessements -1 [ Time Frame: baseline, 4 weeks, 8 weeks ]
    PHQ-9

  15. Health related quality of life (HRQL) assessements -2 [ Time Frame: baseline, 8 weeks ]
    The HRQL assessements EQ-5D-5L measured at baseline and weekly (8 weeks)

  16. Health related quality of life (HRQL) assessements -2 [ Time Frame: baseline, 8 weeks ]
    The HRQL assessements PROCTCAE Endocrine measured at baseline and weekly (8 weeks)

  17. Health related quality of life (HRQL) assessements -2 [ Time Frame: baseline, 8 weeks ]
    The HRQL assessements PROCTCAE taxane measured at baseline and weekly (8 weeks)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patient population for the paperbased PRO capture is part of the PRAEGNANT study population and shall comprize 100 patients, we aim to collect additional web based ePRO datasets for 200 patients
Criteria

Inclusion Criteria:

  • Patients enrolled in PRAEGNANT
  • Women aged ≥18 years
  • Patients with the diagnosis metastasized breast cancer undergoing any form of systemic therapy
  • Patients who are willing and able to sign the informed consent form
  • Patients with therapy change

Exclusion Criteria:

  • Patients who are not eligible for observation due to severe comorbidities or unavailability according to the treating physician
  • Patients who are not able to handle a tablet computer or are unable to write
  • Patients who are not able to understand the nature and extent of the trial and the procedures require

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): NCT03132506


Contacts
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Contact: Markus Wallwiener, MD 0049 6221 56-36956 markus.wallwiener@med.uni-heidelberg.de

Locations
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Germany
Department for Women's Health Recruiting
Tübingen, Germany, 72076
Contact: Andreas Hartkopf, Prof. Dr.         
Sponsors and Collaborators
University Women's Hospital Tübingen
National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Germany
Department of Gynecology and Obstetrics, University Hospital Heidelberg, Germany
Department of Gynecology and Obstetrics, University Hospital Erlangen, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Women's Hospital Tübingen
ClinicalTrials.gov Identifier: NCT03132506    
Other Study ID Numbers: Pepper
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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