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Completed

NCT Number: NCT03525990

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

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Key information

Conditions

Breast Neoplasm Malignant Female

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

A.ö. Krankenhaus St. Josef Braunau GmbH, Braunau am Inn, Upper Austria, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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

Primary outcomes

  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 outcomes

  1. Quality of life assessment

    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.

Sponsors and collaborators

Lead sponsor

Dr. Vera Trommet

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 16, 2018
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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