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

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ClinicalTrials.gov Identifier: NCT03525990
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Vera Trommet, Klinikum Wels-Grieskirchen

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

Condition or disease Intervention/treatment Phase
Breast Neoplasm Malignant Female Other: Questionnaires Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


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)




Primary Outcome Measures :
  1. Patient-physician communication [ Time Frame: 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 :
  1. Quality of life [ Time Frame: 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.

  2. Frequency of discontinuations of therapy [ Time Frame: Up to six months ]
    The frequency of discontinuations will be assessed based on medical reports.

  3. Duration of communication between physician and patient [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525990


Contacts
Contact: Vera Trommet, Dr. +437242415 ext 92178 vera.trommet@klinikum-wegr.at
Contact: Isabella Rauscher, BSc. +437242415 ext 3452

Locations
Austria
A.ö. Krankenhaus St. Josef Braunau GmbH Recruiting
Braunau Am Inn, Upper Austria, Austria, 5280
Contact: Gottfried Hasenöhrl, Prof. Dr.    +437722804 ext 5800    gottfried.hasenoehrl@khbr.at   
Klinikum Wels-Grieskirchen GmbH Recruiting
Wels, Upper Austria, Austria, 4600
Contact: Vera Trommet, Dr.    +437242415 ext 92178    vera.trommet@klinikum-wegr.at   
Contact: Isabella Rauscher, BSc.    +437242415 ext 3452    isabella.rauscher@klinikum-wegr.at   
Sponsors and Collaborators
Dr. Vera Trommet
Investigators
Principal Investigator: Vera Trommet, Dr. Klinikum Wels-Grieskirchen GmbH, 4. Interne

Responsible Party: Dr. Vera Trommet, Principal Investigator, Klinikum Wels-Grieskirchen
ClinicalTrials.gov Identifier: NCT03525990     History of Changes
Other Study ID Numbers: 2017/01
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases