Back to resultsStudy Evaluating the Impact of Electronic Surveys on Patient-physician Communication and Quality of Life in Breast Cancer Patients
Primary Purpose
Breast Neoplasm Malignant Female
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Questionnaires
Sponsored by
About this trial
This is an interventional health services research trial for Breast Neoplasm Malignant Female
Eligibility Criteria
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
Sites / Locations
- A.ö. Krankenhaus St. Josef Braunau GmbH
- Klinikum Wels-Grieskirchen GmbH
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention Arm
Control Arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quality of life assessment
Quality of life will be assessed electronically with EORTC QLQ-C30.
Frequency of discontinuations of therapy
The frequency of discontinuations will be assessed based on medical reports.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03525990
Brief Title
Study Evaluating the Impact of Electronic Surveys on Patient-physician Communication and Quality of Life in Breast Cancer Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Vera Trommet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Malignant Female
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Quality of life questionnaires on iPads with CHES (Computer-based Health Evaluation System), paper-based questionnaire (EORTC QLQ-COMU26)
Primary Outcome Measure Information:
Title
Patient-physician communication
Description
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.
Time Frame
Up to six months
Secondary Outcome Measure Information:
Title
Quality of life assessment
Description
Quality of life will be assessed electronically with EORTC QLQ-C30.
Time Frame
Arm A: at every visit for six months; Arm B: at baseline, three months, six months
Title
Frequency of discontinuations of therapy
Description
The frequency of discontinuations will be assessed based on medical reports.
Time Frame
Up to six months
Title
Duration of communication between physician and patient
Description
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.
Time Frame
At baseline, three months, six months in both groups
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vera Trommet, Dr.
Organizational Affiliation
Klinikum Wels-Grieskirchen GmbH, 4. Interne
Official's Role
Principal Investigator
Facility Information:
Facility Name
A.ö. Krankenhaus St. Josef Braunau GmbH
City
Braunau Am Inn
State/Province
Upper Austria
ZIP/Postal Code
5280
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
State/Province
Upper Austria
ZIP/Postal Code
4600
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study Evaluating the Impact of Electronic Surveys on Patient-physician Communication and Quality of Life in Breast Cancer Patients
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