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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
400
Structured (video-)call by qualified nursing staff with breast cancer patients, with the intention to overcome side effects, distress or non-adherence to endocrine therapy.
Klinikum rechts der Isar, Frauenklinik, Technische Universität München
Munich, Germany, Germany
Quality of Life (QOL)
Change in EORTC QLQ-C30 subscale
Time frame: 24 Months
Quality of Life (QOL)
Change in EORTC QLQ-BR23
Time frame: 24 Months
Quality of Life (QOL)
Change in EORTC QLQ-BR23
Time frame: 6, 12, 18 Months
Quality of Life (QOL)
Change in EORTC QLQ-C30
Time frame: 6, 12, 18 Months
Adherence
Number of days missing tablets
Time frame: 24 Months
Mental health
Change in GAD-2
Time frame: 24 Months
Mental health
Change in Distress thermometer
Time frame: 24 Months
Mental health
Change in PHQ-2
Time frame: 24 Months
Adverse effect of therapy
Count of side effects cat. 3/4
Time frame: 24 Months
Assessment of new digital form of care
Usefulness of application
Time frame: 24 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Progression free survival
PFS rate
Time frame: 24 Months
Overal survival
OS rate
Time frame: 24 Months
Total cost
Cost difference
Time frame: 24 Months
Disease-specific costs
Cost difference
Time frame: 24 Months
Effectiveness (QOL)
Change in EORTC QLQ-C30 subscale
Time frame: 24 Months
Efficiency (QALY)
Qaly-Index from EQ-5D-5L
Time frame: 24 Months
Patient Satisfaction
Short Assessment of Patient Satisfaction - Satisfaction Index
Time frame: 6, 24 Months
Stakeholder perspective
Stakeholder perspective questionnaires
Time frame: 12, 24 Months
Number of Interventions
Automatically initiated reasons for interventions
Time frame: 24 Months