NCT03132506

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2024

Completed
Last Updated

January 22, 2025

Status Verified

December 1, 2024

Enrollment Period

7.1 years

First QC Date

April 12, 2017

Last Update Submit

January 17, 2025

Conditions

Breast Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

  • QLQ-C30 questionnaire for baseline

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

    8 weeks

Secondary Outcomes (17)

  • All other questionnaires for baseline and follow up time points.

    Baseline, 8 weeks

  • Influence factors for the completion rates

    8 weeks

  • Influence factors for the completion rates

    8 weeks

  • Influence factors for the completion rates

    8 weeks

  • Influence factors for the completion rates

    8 weeks

  • +12 more secondary outcomes

Study Arms (2)

paper-based patient-reported-outcomes

Other: patient-reported-outcomes

on web-based patient-reported-outcomes

Other: patient-reported-outcomes

Interventions

patient-reported-outcomesOTHER

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-outcomespaper-based patient-reported-outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Women's Health

Tübingen, 72076, Germany

Location

Related Publications (1)

  • 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.

    PMID: 28912116DERIVED

Related Links

MeSH Terms

Interventions

Patient Reported Outcome Measures

Intervention Hierarchy (Ancestors)

Health Care SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Services ResearchHealth PlanningHealth Care Economics and OrganizationsPatient Outcome AssessmentOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 28, 2017

Study Start

June 1, 2017

Primary Completion

July 17, 2024

Study Completion

July 17, 2024

Last Updated

January 22, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)