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

Not Applicable

Completed

• Conditions: Breast Neoplasm Malignant Female
• Interventions: Other: Questionnaires

• Registration Number: NCT03525990
• Lead Sponsor: Dr. Vera Trommet

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-10
• Study First Submitted: 2018-04-24
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-16
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Questionnaires	Quality of life questionnaires (electronic patient reported outcomes) to be filled out by the patients at every visit. Quality of life data is fully available for physicians. Paper-based questionnaire (EORTC QLQ-COMU26) at baseline, after three months and after six months.
Control Arm	Questionnaires	Quality of life questionnaires (electronic patient reported outcomes) only to filled out by the patients at baseline, after three months and after six months. Quality of life data is hidden for physicians. Paper-based questionnaire (EORTC QLQ-COMU26) at baseline, after three months and after six months.

Primary Outcome Measures

Name	Time	Method
Patient-physician communication	Up to six months	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life assessment	Arm A: at every visit for six months; Arm B: at baseline, three months, six months	Quality of life will be assessed electronically with EORTC QLQ-C30.
Frequency of discontinuations of therapy	Up to six months	The frequency of discontinuations will be assessed based on medical reports.
Duration of communication between physician and patient	At baseline, three months, six months in both groups	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.

Trial Locations

Locations (2)

A.ö. Krankenhaus St. Josef Braunau GmbH; 🇦🇹 Braunau Am Inn, Upper Austria, Austria

Klinikum Wels-Grieskirchen GmbH; 🇦🇹 Wels, Upper Austria, Austria