To hear about similar clinical trials, please enter your email below
Trial Title:
Primary Hormone-sensitive Breast Cancer: Need-driven Health Care Improvement by Patient-centred Digital Application
NCT ID:
NCT05503160
Condition:
New Healthcare Approach
Conditions: Official terms:
Hypersensitivity
Conditions: Keywords:
quality of life
adherence
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Intervention
Description:
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.
Arm group label:
Intervention
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Klinikum rechts der Isar, Frauenklinik, Technische Universität München
Address:
City:
Munich
Zip:
81675
Country:
Germany
Start date:
January 1, 2022
Completion date:
June 2026
Lead sponsor:
Agency:
Technical University of Munich
Agency class:
Other
Collaborator:
Agency:
Federal Joint Committee
Agency class:
Other
Source:
Technical University of Munich
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05503160