Breast Cancer MetastaticNCT03132506
E-Health Portal for Individualized Treatment Monitoring and Patient Engagement in Oncology Research
An observational study of Breast Cancer Metastatic, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Evaluation of patient acceptance and characterization of response behaviour for web-based compared with respective paperbacked patient reported outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer Metastatic
- What is being tested?
- patient-reported-outcomes
- How many people
- 106 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2017to 17 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Evaluation of patient acceptance and characterization of response behaviour for web-based compared with respective paperbacked patient reported outcomes.
Read the 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.
- Conditions
- Breast Cancer Metastatic
- Being tested
- patient-reported-outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| paper-based patient-reported-outcomes | Not described Receives: Other: patient-reported-outcomes | |
| on web-based patient-reported-outcomes | Not described Receives: Other: patient-reported-outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
QLQ-C30 questionnaire for baseline
Overall patient completion rate in the paperbacked questionnaire and the web-tool, respectively
Measured: 8 weeks
Secondary outcomes (17)
All other questionnaires for baseline and follow up time points.
Overall patient completion rate in the paperbacked questionnaire and the web-tool, respectively,
Measured: Baseline, 8 weeks
Influence factors for the completion rates
age
Measured: 8 weeks
Influence factors for the completion rates
line of treatment
Measured: 8 weeks
Influence factors for the completion rates
treatment
Measured: 8 weeks
Influence factors for the completion rates
technical skills
Measured: 8 weeks
Influence factors for the completion rates
patient's satisfaction
Measured: 8 weeks
Adverse events-1
The date of clinical diagnosis of AE compared with the date of early AE onset
Measured: 8 weeks
Adverse events-2
Consistency of AE documentation ePRO and clinician based
Measured: 8 weeks
Patient satisfaction
at baseline, after 4 weeks and after 8 weeks
Measured: baseline, 4 weeks, 8 weeks
Health related quality of life (HRQL) assessements -1
EORTC QLQ C-30
Measured: baseline, 4 weeks, 8 weeks
Health related quality of life (HRQL) assessements -1
BR23
Measured: baseline, 4 weeks, 8 weeks
Health related quality of life (HRQL) assessements -1
NCCN distress thermometer,
Measured: baseline, 4 weeks, 8 weeks
Health related quality of life (HRQL) assessements -1
EQ-VAS
Measured: baseline, 4 weeks, 8 weeks
Health related quality of life (HRQL) assessements -1
PHQ-9
Measured: 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)
Measured: baseline, 8 weeks
Health related quality of life (HRQL) assessements -2
The HRQL assessements PROCTCAE Endocrine measured at baseline and weekly (8 weeks)
Measured: baseline, 8 weeks
Health related quality of life (HRQL) assessements -2
The HRQL assessements PROCTCAE taxane measured at baseline and weekly (8 weeks)
Measured: baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 Jun 2017
- Primary completion17 Jul 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Germany, University Hospital Heidelberg, University Hospital Erlangen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132506
- Sponsor's protocol ID
- Pepper
- Status last verified
- Dec 2024
- First submitted
- 12 Apr 2017
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28912116
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03132506
- Acronym / sponsor ID
- Pepper
- Conditions
- Breast Cancer Metastatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Germany, University Hospital Heidelberg, University Hospital Erlangen
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of patient acceptance and characterization of response behaviour for web-based compared with respective paperbacked 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paper-based patient-reported-outcomes | – | Other: patient-reported-outcomes |
| on web-based patient-reported-outcomes | – | Other: patient-reported-outcomes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient-reported-outcomesExplorative 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 | Other | on web-based patient-reported-outcomes, paper-based patient-reported-outcomes |
Primary outcome
QLQ-C30 questionnaire for baseline
Time frame: 8 weeks
Overall patient completion rate in the paperbacked questionnaire and the web-tool, respectively
17 secondary outcomes
All other questionnaires for baseline and follow up time points.
Time frame: Baseline, 8 weeks
Influence factors for the completion rates
Time frame: 8 weeks
Influence factors for the completion rates
Time frame: 8 weeks
Influence factors for the completion rates
Time frame: 8 weeks
Influence factors for the completion rates
Time frame: 8 weeks
Influence factors for the completion rates
Time frame: 8 weeks
Adverse events-1
Time frame: 8 weeks
Adverse events-2
Time frame: 8 weeks
Patient satisfaction
Time frame: baseline, 4 weeks, 8 weeks
Health related quality of life (HRQL) assessements -1
Time frame: baseline, 4 weeks, 8 weeks
Health related quality of life (HRQL) assessements -1
Time frame: baseline, 4 weeks, 8 weeks
Health related quality of life (HRQL) assessements -1
Time frame: baseline, 4 weeks, 8 weeks
Health related quality of life (HRQL) assessements -1
Time frame: baseline, 4 weeks, 8 weeks
Health related quality of life (HRQL) assessements -1
Time frame: baseline, 4 weeks, 8 weeks
Health related quality of life (HRQL) assessements -2
Time frame: baseline, 8 weeks
Health related quality of life (HRQL) assessements -2
Time frame: baseline, 8 weeks
Health related quality of life (HRQL) assessements -2
Time frame: baseline, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Derived from this study: PubMed 28912116Wallwiener 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Metastatic, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QLQ-C30 questionnaire for baseline (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03132506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.