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

NCT ID: NCT03132506

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2024-07-17

Brief Summary

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

Detailed Description

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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.

Conditions

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Breast Cancer Metastatic

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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paper-based patient-reported-outcomes

patient-reported-outcomes

Intervention Type 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

on web-based patient-reported-outcomes

patient-reported-outcomes

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Germany

UNKNOWN

Sponsor Role collaborator

Department of Gynecology and Obstetrics, University Hospital Heidelberg, Germany

UNKNOWN

Sponsor Role collaborator

Department of Gynecology and Obstetrics, University Hospital Erlangen, Germany

UNKNOWN

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department for Women's Health

Tübingen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 28912116 (View on PubMed)

Related Links

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Other Identifiers

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Pepper

Identifier Type: -

Identifier Source: org_study_id

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