Primary Hormone-sensitive Breast Cancer: Need-driven Health Care Improvement by Patient-centred Digital Application
- Conditions
- New Healthcare Approach
- Interventions
- Behavioral: Intervention
- Registration Number
- NCT05503160
- Lead Sponsor
- Technical University of Munich
- Brief Summary
The investigators designed a prospective, 2-armed, cluster-randomized multicenter clinical trial on the effect of a by a digital application triggered intervention on quality of life and therapy-adherence among breast cancer patients, compared to standard of care.
- Detailed Description
With validated questionnaires, patient reported outcome monitoring data on quality of life, distress and therapy-adherence are collected. In case of pathologic values, the attending breast center gets advised to intervene according to individual requirements.
For women with breast cancer, disease and therapy come along with loss of quality of life. Therapy and its side effects often result in unauthorized discontinuation of therapy by patients. Non-adherence rates to endocrine therapy (ET) range from 31% to 73%. These patients have a poorer prognosis due to recurrence, progression and cancer deaths. Positive effects to increase therapy-adherence were shown for bidirectional communication. Furthermore the use of apps with reminder functions can increase adherence to cancer therapy. The intention within this project is to improve care of patients with primary breast cancer.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 400
- primary, hormone-sensitive breast cancer
- indication for adjuvant endocrine therapy (aromatase-inhibitor, tamoxifen, GnRH-analogue allone or in combination with tamoxifen/ aromatas inhibitor; combination of endocrine therapy with CDK 4/6-inhibitor/ antibody therapy/ radiotherapy)
- start of endocrine therapy <= 3 months ago
- patients with public health ensurance
- patients who are legally competent and able to understand and follow instructions of the study staff
- present informed consent
- no use of internet or digital applications
- advanced, metastatic breast cancer
- simultaneous serious disease
- life expectancy < 2 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Intervention With validated questionnaires, patient reported outcome monitoring data on quality of life, distress and therapy-adherence are collected. In case of pathologic values, the attending breast center gets advised to intervene according to individual requirements.
- Primary Outcome Measures
Name Time Method Quality of Life (QOL) 24 Months Change in EORTC QLQ-C30 subscale
- Secondary Outcome Measures
Name Time Method Progression free survival 24 Months PFS rate
Overal survival 24 Months OS rate
Adverse effect of therapy 24 Months Count of side effects cat. 3/4
Quality of Life (QOL) 6, 12, 18 Months Change in EORTC QLQ-C30
Assessment of new digital form of care 24 Months Usefulness of application
Efficiency (QALY) 24 Months Qaly-Index from EQ-5D-5L
Adherence 24 Months Number of days missing tablets
Patient Satisfaction 6, 24 Months Short Assessment of Patient Satisfaction - Satisfaction Index
Number of Interventions 24 Months Automatically initiated reasons for interventions
Mental health 24 Months Change in PHQ-2
Disease-specific costs 24 Months Cost difference
Effectiveness (QOL) 24 Months Change in EORTC QLQ-C30 subscale
Stakeholder perspective 12, 24 Months Stakeholder perspective questionnaires
Total cost 24 Months Cost difference
Trial Locations
- Locations (1)
Klinikum rechts der Isar, Frauenklinik, Technische Universität München
🇩🇪Munich, Germany