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

Dr. Vera Trommet

Status: Completed

Conditions: Breast Neoplasm Malignant Female

Treatments: Other: Questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT03525990

2017/01

Details and patient eligibility

About

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

Enrollment: 62 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups, including a placebo group

Intervention Arm

Active Comparator group

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.

Treatment:

Other: Questionnaires

Control Arm

Placebo Comparator group

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.

Treatment:

Other: Questionnaires