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

D

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)

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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