New Healthcare Approach
Conditions
Keywords
quality of life, adherence
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.
Interventions
BEHAVIORALIntervention
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.
Sponsors
Federal Joint Committee
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QOL) | 24 Months | Change in EORTC QLQ-C30 subscale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 24 Months | Number of days missing tablets |
| Mental health | 24 Months | Change in GAD-2 |
| Adverse effect of therapy | 24 Months | Count of side effects cat. 3/4 |
| Assessment of new digital form of care | 24 Months | Usefulness of application |
| Progression free survival | 24 Months | PFS rate |
| Overal survival | 24 Months | OS rate |
| Quality of Life (QOL) | 24 Months | Change in EORTC QLQ-BR23 |
| Disease-specific costs | 24 Months | Cost difference |
| Effectiveness (QOL) | 24 Months | Change in EORTC QLQ-C30 subscale |
| Efficiency (QALY) | 24 Months | Qaly-Index from EQ-5D-5L |
| Patient Satisfaction | 6, 24 Months | Short Assessment of Patient Satisfaction - Satisfaction Index |
| Stakeholder perspective | 12, 24 Months | Stakeholder perspective questionnaires |
| Number of Interventions | 24 Months | Automatically initiated reasons for interventions |
| Total cost | 24 Months | Cost difference |
Countries
Germany
Outcome results
None listed