Clinical trial NCT05503160: Primary Hormone-sensitive Breast Cancer: Need-driven Health Care Improvement by Patient-centred Digital Application
Official title: Primäres Hormon-Sensitives Mammakarzinom: Bedarfsgerechte Optimierung Der Versorgung Durch Eine Patientenzentrierte, Digitale Anwendung
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: New Healthcare Approach
Keywords: quality of life
adherence
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Federal Joint Committee
First posted: 2022-08-16
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* no use of internet or digital applications
* advanced, metastatic breast cancer
* simultaneous serious disease
* life expectancy \< 2 years

Primary outcomes:
measure: Quality of Life (QOL)
timeFrame: 24 Months
Secondary outcomes:
measure: Quality of Life (QOL)
timeFrame: 24 Months
measure: Quality of Life (QOL)
timeFrame: 6, 12, 18 Months
measure: Quality of Life (QOL)
timeFrame: 6, 12, 18 Months
measure: Adherence
timeFrame: 24 Months
measure: Mental health
timeFrame: 24 Months
measure: Mental health
timeFrame: 24 Months
measure: Mental health
timeFrame: 24 Months
measure: Adverse effect of therapy
timeFrame: 24 Months
measure: Assessment of new digital form of care
timeFrame: 24 Months
measure: Progression free survival
timeFrame: 24 Months
measure: Overal survival
timeFrame: 24 Months
measure: Total cost
timeFrame: 24 Months
measure: Disease-specific costs
timeFrame: 24 Months
measure: Effectiveness (QOL)
timeFrame: 24 Months
measure: Efficiency (QALY)
timeFrame: 24 Months
measure: Patient Satisfaction
timeFrame: 6, 24 Months
measure: Stakeholder perspective
timeFrame: 12, 24 Months
measure: Number of Interventions
timeFrame: 24 Months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar, Frauenklinik, Technische Universität München
Study officials:
affiliation: Technical University of Munich
name: Marion Kiechle, Prof. Dr. med.
role: STUDY_DIRECTOR
References: