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

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

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

Study Overview

• Status: Completed
• Conditions: Breast Neoplasm Malignant Female
• Intervention / Treatment: Other: Questionnaires

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vera Trommet, Dr.; Phone Number: 92178 +437242415; Email: vera.trommet@klinikum-wegr.at
• Study Contact Backup: Name: Isabella Rauscher, BSc.; Phone Number: 3452 +437242415

Study Locations

• Austria
  • Upper Austria
    • Braunau Am Inn, Upper Austria, Austria, 5280
      • A.ö. Krankenhaus St. Josef Braunau GmbH
    • Wels, Upper Austria, Austria, 4600
      • Klinikum Wels-Grieskirchen GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Arm; 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.	Other: Questionnaires; Quality of life questionnaires on iPads with CHES (Computer-based Health Evaluation System), paper-based questionnaire (EORTC QLQ-COMU26)
Placebo Comparator: Control Arm; 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.	Other: Questionnaires; Quality of life questionnaires on iPads with CHES (Computer-based Health Evaluation System), paper-based questionnaire (EORTC QLQ-COMU26)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of discontinuations of therapy	The frequency of discontinuations will be assessed based on medical reports.	Up to six months
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
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

Collaborators and Investigators

• Sponsor: Dr. Vera Trommet

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Site; Breast Diseases; Neoplasms; Breast Neoplasms
• Other Study ID Numbers: 2017/01

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