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Completed

NCT Number: NCT03132506

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

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

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Key information

Conditions

Breast Cancer Metastatic

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Department for Women's Health

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patient-reported-outcomes

Other

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 outcomes

  1. QLQ-C30 questionnaire for baseline

    Time frame: 8 weeks

    Overall patient completion rate in the paperbacked questionnaire and the web-tool, respectively

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Department of Gynecology and Obstetrics, University Hospital Erlangen, Germany
  • National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Germany
  • University Hospital Heidelberg

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Apr 28, 2017
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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