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

NCT03525990 | Completed

• 1 other identifier: 2017/01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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

Conditions

Breast Neoplasm Malignant Female

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of life assessment

  Arm A: at every visit for six months; Arm B: at baseline, three months, six months

• Frequency of discontinuations of therapy

  Up to six months

• Duration of communication between physician and patient

  At baseline, three months, six months in both groups

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

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

Control Arm

PLACEBO COMPARATOR

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

Interventions

Questionnaires OTHER

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

Control Arm; Intervention Arm

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Dr. Vera Trommet: lead

Study Sites (2)

A.ö. Krankenhaus St. Josef Braunau GmbH

Braunau am Inn, Upper Austria, 5280, Austria

Location

Klinikum Wels-Grieskirchen GmbH

Wels, Upper Austria, 4600, Austria

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Vera Trommet, Dr.

  Klinikum Wels-Grieskirchen GmbH, 4. Interne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 16, 2018
• Study Start: January 10, 2018
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)