Study Evaluating the Impact of Electronic Surveys on Patient-physician Communication and Quality of Life in Breast Cancer Patients

Breast Neoplasm Malignant Female Clinical Trial

Official title:

PRO-COM Project: Randomized-controlled Study Evaluating the Impact of Electronic Patient Reported Outcome (ePRO) Surveys on Patient-physician Communication and Quality of Life in Patients With Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03525990
• Other study ID #: 2017/01
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: April 30, 2022

Study information

• Verified date: April 2023
• Source: Klinikum Wels-Grieskirchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PRO-COM Project: Randomized-controlled study evaluating the impact of electronic patient reported outcome (ePRO) surveys on patient-physician communication and quality of life in patients with advanced breast cancer

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Stage IV breast cancer

• Start of a systemic anti cancer therapy: chemotherapy -/+ antibody therapy 1st until 3rd line (palliative), endocrine therapy or other therapy without limit

• Estimated life expectancy of minimum six months

• Signed informed consent

• No cognitive or speech impairments

Related Conditions & MeSH terms

• Breast Neoplasm Malignant Female
• Breast Neoplasms
• Neoplasms

Intervention

Other:
• Questionnaires
Quality of life questionnaires on iPads with CHES (Computer-based Health Evaluation System), paper-based questionnaire (EORTC QLQ-COMU26)

Locations

Country	Name	City	State
Austria	A.ö. Krankenhaus St. Josef Braunau GmbH	Braunau Am Inn	Upper Austria
Austria	Klinikum Wels-Grieskirchen GmbH	Wels	Upper Austria

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Vera Trommet

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-physician communication	The communication between patient and physician will be assessed with EORTC QLQ-COMU26. Presumably some patients have privacy concerns with electronic questionnaires. The EORTC-COMU26 is the most important questionnaire in this study because it is needed for the primary endpoint. It contains sensitive questions about how the patient experiences the communication during the visit. In order to avoid patients not filling out the questionnaire due to privacy concerns or being afraid of giving an honest opinion and the physician could read it electronically, the EORTC QLQ-COMU26 is paper-based and the patients can hand them in in the study office.	Up to six months
Secondary	Quality of life assessment	Quality of life will be assessed electronically with EORTC QLQ-C30.	Arm A: at every visit for six months; Arm B: at baseline, three months, six months
Secondary	Frequency of discontinuations of therapy	The frequency of discontinuations will be assessed based on medical reports.	Up to six months
Secondary	Duration of communication between physician and patient	Physicians call the study office at the beginning and at the end of the consultation at baseline, three months and six months. They will record the duration of the consultation.	At baseline, three months, six months in both groups