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| Name | Class |
|---|---|
| Federal Joint Committee | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | 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. |
|
| Control | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QOL) | Change in EORTC QLQ-C30 subscale | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QOL) | Change in EORTC QLQ-BR23 | 24 Months |
| Quality of Life (QOL) | Change in EORTC QLQ-BR23 | 6, 12, 18 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marion Kiechle, Prof. Dr. med. | Technical University of Munich | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum rechts der Isar, Frauenklinik, Technische Universität München | Munich | Germany | 81675 | Germany |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Quality of Life (QOL) | Change in EORTC QLQ-C30 | 6, 12, 18 Months |
| Adherence | Number of days missing tablets | 24 Months |
| Mental health | Change in GAD-2 | 24 Months |
| Mental health | Change in Distress thermometer | 24 Months |
| Mental health | Change in PHQ-2 | 24 Months |
| Adverse effect of therapy | Count of side effects cat. 3/4 | 24 Months |
| Assessment of new digital form of care | Usefulness of application | 24 Months |
| Progression free survival | PFS rate | 24 Months |
| Overal survival | OS rate | 24 Months |
| Total cost | Cost difference | 24 Months |
| Disease-specific costs | Cost difference | 24 Months |
| Effectiveness (QOL) | Change in EORTC QLQ-C30 subscale | 24 Months |
| Efficiency (QALY) | Qaly-Index from EQ-5D-5L | 24 Months |
| Patient Satisfaction | Short Assessment of Patient Satisfaction - Satisfaction Index | 6, 24 Months |
| Stakeholder perspective | Stakeholder perspective questionnaires | 12, 24 Months |
| Number of Interventions | Automatically initiated reasons for interventions | 24 Months |