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

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

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

Study Overview

• Status: Unknown
• Conditions: Breast Cancer Metastatic
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Markus Wallwiener, MD; Phone Number: 0049 6221 56-36956; Email: markus.wallwiener@med.uni-heidelberg.de

Study Locations

• Germany
  • Tübingen, Germany, 72076
    • Recruiting
    • Department for Women's Health
    • Contact: Andreas Hartkopf, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QLQ-C30 questionnaire for baseline	Overall patient completion rate in the paperbacked questionnaire and the web-tool, respectively	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All other questionnaires for baseline and follow up time points.	Overall patient completion rate in the paperbacked questionnaire and the web-tool, respectively,	Baseline, 8 weeks
Influence factors for the completion rates	age	8 weeks
Influence factors for the completion rates	line of treatment	8 weeks
Influence factors for the completion rates	treatment	8 weeks
Influence factors for the completion rates	technical skills	8 weeks
Influence factors for the completion rates	patient's satisfaction	8 weeks
Adverse events-1	The date of clinical diagnosis of AE compared with the date of early AE onset	8 weeks
Adverse events-2	Consistency of AE documentation ePRO and clinician based	8 weeks
Patient satisfaction	at baseline, after 4 weeks and after 8 weeks	baseline, 4 weeks, 8 weeks
Health related quality of life (HRQL) assessements -1	EORTC QLQ C-30	baseline, 4 weeks, 8 weeks
Health related quality of life (HRQL) assessements -1	BR23	baseline, 4 weeks, 8 weeks
Health related quality of life (HRQL) assessements -1	NCCN distress thermometer,	baseline, 4 weeks, 8 weeks
Health related quality of life (HRQL) assessements -1	EQ-VAS	baseline, 4 weeks, 8 weeks
Health related quality of life (HRQL) assessements -1	PHQ-9	baseline, 4 weeks, 8 weeks
Health related quality of life (HRQL) assessements -2	The HRQL assessements EQ-5D-5L measured at baseline and weekly (8 weeks)	baseline, 8 weeks
Health related quality of life (HRQL) assessements -2	The HRQL assessements PROCTCAE Endocrine measured at baseline and weekly (8 weeks)	baseline, 8 weeks
Health related quality of life (HRQL) assessements -2	The HRQL assessements PROCTCAE taxane measured at baseline and weekly (8 weeks)	baseline, 8 weeks

Collaborators and Investigators

• 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PEPPER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No