Klinikum rechts der Isar, Frauenklinik, Technische Universität München
Munich, Germany, 81675
NCT Number: NCT05503160
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
Female
Interventional
Not applicable
Munich, Germany, 81675
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 24 Months
Change in EORTC QLQ-C30 subscale
Time frame: 24 Months
Change in EORTC QLQ-BR23
Time frame: 6, 12, 18 Months
Change in EORTC QLQ-BR23
Time frame: 6, 12, 18 Months
Change in EORTC QLQ-C30
Time frame: 24 Months
Number of days missing tablets
Time frame: 24 Months
Change in GAD-2
Time frame: 24 Months
Change in Distress thermometer
Time frame: 24 Months
Change in PHQ-2
Time frame: 24 Months
Count of side effects cat. 3/4
Time frame: 24 Months
Usefulness of application
Time frame: 24 Months
PFS rate
Time frame: 24 Months
OS rate
Time frame: 24 Months
Cost difference
Time frame: 24 Months
Cost difference
Time frame: 24 Months
Change in EORTC QLQ-C30 subscale
Time frame: 24 Months
Qaly-Index from EQ-5D-5L
Time frame: 6, 24 Months
Short Assessment of Patient Satisfaction - Satisfaction Index
Time frame: 12, 24 Months
Stakeholder perspective questionnaires
Time frame: 24 Months
Automatically initiated reasons for interventions
Technical University of Munich
Other
Primäres Hormon-Sensitives Mammakarzinom: Bedarfsgerechte Optimierung Der Versorgung Durch Eine Patientenzentrierte, Digitale Anwendung
Acronym: PRISMA
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