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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

Tracking Information
First Submitted Date April 12, 2017
First Posted Date April 28, 2017
Last Update Posted Date February 11, 2020
Actual Study Start Date June 1, 2017
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 5, 2017)
QLQ-C30 questionnaire for baseline [ Time Frame: 8 weeks ]
Overall patient completion rate in the paperbacked questionnaire and the web-tool, respectively
Original Primary Outcome Measures
 (submitted: April 24, 2017)
QLQ-C30 questionnaire for baseline [ Time Frame: 8 weeks ]
Overall patient completion rate in the paper based questionnaire and the web-tool, respectively
Change History
Current Secondary Outcome Measures
 (submitted: May 5, 2017)
  • 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,
  • Influence factors for the completion rates [ Time Frame: 8 weeks ]
    age
  • Influence factors for the completion rates [ Time Frame: 8 weeks ]
    line of treatment
  • Influence factors for the completion rates [ Time Frame: 8 weeks ]
    treatment
  • Influence factors for the completion rates [ Time Frame: 8 weeks ]
    technical skills
  • Influence factors for the completion rates [ Time Frame: 8 weeks ]
    patient's satisfaction
  • Adverse events-1 [ Time Frame: 8 weeks ]
    The date of clinical diagnosis of AE compared with the date of early AE onset
  • Adverse events-2 [ Time Frame: 8 weeks ]
    Consistency of AE documentation ePRO and clinician based
  • Patient satisfaction [ Time Frame: baseline, 4 weeks, 8 weeks ]
    at baseline, after 4 weeks and after 8 weeks
  • Health related quality of life (HRQL) assessements -1 [ Time Frame: baseline, 4 weeks, 8 weeks ]
    EORTC QLQ C-30
  • Health related quality of life (HRQL) assessements -1 [ Time Frame: baseline, 4 weeks, 8 weeks ]
    BR23
  • Health related quality of life (HRQL) assessements -1 [ Time Frame: baseline, 4 weeks, 8 weeks ]
    NCCN distress thermometer,
  • Health related quality of life (HRQL) assessements -1 [ Time Frame: baseline, 4 weeks, 8 weeks ]
    EQ-VAS
  • Health related quality of life (HRQL) assessements -1 [ Time Frame: baseline, 4 weeks, 8 weeks ]
    PHQ-9
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures
 (submitted: April 24, 2017)
  • All other questionnaires for baseline and follow up time points. [ Time Frame: Baseline, 8 weeks ]
    Overall patient completion rate in the paper based questionnaire and the web-tool, respectively,
  • Influence factors for the completion rates [ Time Frame: 8 weeks ]
    age
  • Influence factors for the completion rates [ Time Frame: 8 weeks ]
    line of treatment
  • Influence factors for the completion rates [ Time Frame: 8 weeks ]
    treatment
  • Influence factors for the completion rates [ Time Frame: 8 weeks ]
    technical skills
  • Influence factors for the completion rates [ Time Frame: 8 weeks ]
    patient's satisfaction
  • Adverse events-1 [ Time Frame: 8 weeks ]
    The date of clinical diagnosis of AE compared with the date of early AE onset
  • Adverse events-2 [ Time Frame: 8 weeks ]
    Consistency of AE documentiation ePRO and clinician based
  • Patient statisfaction [ Time Frame: baseline, 4 weeks, 8 weeks ]
    at baseline, after 4 weeks and after 8 weeks
  • Health related quality of life (HRQL) assessements -1 [ Time Frame: baseline, 4 weeks, 8 weeks ]
    EORTC QLQ C-30
  • Health related quality of life (HRQL) assessements -1 [ Time Frame: baseline, 4 weeks, 8 weeks ]
    BR23
  • Health related quality of life (HRQL) assessements -1 [ Time Frame: baseline, 4 weeks, 8 weeks ]
    NCCN distress thermometer,
  • Health related quality of life (HRQL) assessements -1 [ Time Frame: baseline, 4 weeks, 8 weeks ]
    PHQ-9, EQ-VAS
  • Health related quality of life (HRQL) assessements -1 [ Time Frame: baseline, 4 weeks, 8 weeks ]
    EQ-VAS
  • Health related quality of life (HRQL) assessements -2 [ Time Frame: baseline, 8 weeks ]
    The HRQL assessements EQ-5D-5L and PROCTCAE Endocrine or PROCTCAE Taxan measured at baseline and weekly (8 weeks)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title E-Health Portal for Individualized Treatment Monitoring and Patient Engagement in Oncology Research
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
Brief Summary Evaluation of patient acceptance and characterization of response behaviour for web-based compared with respective paperbacked 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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Breast Cancer Metastatic
Intervention 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
Study Groups/Cohorts
  • paper-based patient-reported-outcomes
    Intervention: Other: patient-reported-outcomes
  • on web-based patient-reported-outcomes
    Intervention: Other: patient-reported-outcomes
Publications * Wallwiener M, Matthies L, Simoes E, Keilmann L, Hartkopf AD, Sokolov AN, Walter CB, Sickenberger N, Wallwiener S, Feisst M, Gass P, Fasching PA, Lux MP, Wallwiener D, Taran FA, Rom J, Schneeweiss A, Graf J, Brucker SY. Reliability of an e-PRO Tool of EORTC QLQ-C30 for Measurement of Health-Related Quality of Life in Patients With Breast Cancer: Prospective Randomized Trial. J Med Internet Res. 2017 Sep 14;19(9):e322. doi: 10.2196/jmir.8210.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 24, 2017)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 1, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Markus Wallwiener, MD 0049 6221 56-36956 markus.wallwiener@med.uni-heidelberg.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03132506
Other Study ID Numbers Pepper
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Women's Hospital Tübingen
Study Sponsor University Women's Hospital Tübingen
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
Investigators Not Provided
PRS Account University Women's Hospital Tübingen
Verification Date February 2020