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

Breast Cancer Metastatic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03132506
• Other study ID #: Pepper
• Status: Recruiting
• Start date: June 1, 2017
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2020
• Source: University Women's Hospital Tübingen
• Contact: Markus Wallwiener, MD
• Phone: 0049 6221 56-36956
• Email: markus.wallwiener[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
Germany	Department for Women's Health	Tübingen

Sponsors (4)

Lead Sponsor	Collaborator
University Women's Hospital Tübingen	Department of Gynecology and Obstetrics, University Hospital Erlangen, Germany, Department of Gynecology and Obstetrics, University Hospital Heidelberg, Germany, National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QLQ-C30 questionnaire for baseline	Overall patient completion rate in the paperbacked questionnaire and the web-tool, respectively	8 weeks
Secondary	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
Secondary	Influence factors for the completion rates	age	8 weeks
Secondary	Influence factors for the completion rates	line of treatment	8 weeks
Secondary	Influence factors for the completion rates	treatment	8 weeks
Secondary	Influence factors for the completion rates	technical skills	8 weeks
Secondary	Influence factors for the completion rates	patient's satisfaction	8 weeks
Secondary	Adverse events-1	The date of clinical diagnosis of AE compared with the date of early AE onset	8 weeks
Secondary	Adverse events-2	Consistency of AE documentation ePRO and clinician based	8 weeks
Secondary	Patient satisfaction	at baseline, after 4 weeks and after 8 weeks	baseline, 4 weeks, 8 weeks
Secondary	Health related quality of life (HRQL) assessements -1	EORTC QLQ C-30	baseline, 4 weeks, 8 weeks
Secondary	Health related quality of life (HRQL) assessements -1	BR23	baseline, 4 weeks, 8 weeks
Secondary	Health related quality of life (HRQL) assessements -1	NCCN distress thermometer,	baseline, 4 weeks, 8 weeks
Secondary	Health related quality of life (HRQL) assessements -1	EQ-VAS	baseline, 4 weeks, 8 weeks
Secondary	Health related quality of life (HRQL) assessements -1	PHQ-9	baseline, 4 weeks, 8 weeks
Secondary	Health related quality of life (HRQL) assessements -2	The HRQL assessements EQ-5D-5L measured at baseline and weekly (8 weeks)	baseline, 8 weeks
Secondary	Health related quality of life (HRQL) assessements -2	The HRQL assessements PROCTCAE Endocrine measured at baseline and weekly (8 weeks)	baseline, 8 weeks
Secondary	Health related quality of life (HRQL) assessements -2	The HRQL assessements PROCTCAE taxane measured at baseline and weekly (8 weeks)	baseline, 8 weeks