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

Login to your account

Did you forget your password?