NCT05503160

Primary Hormone-sensitive Breast Cancer: Need-driven Health Care Improvement by Patient-centred Digital Application

Primäres Hormon-Sensitives Mammakarzinom: Bedarfsgerechte Optimierung Der Versorgung Durch Eine Patientenzentrierte, Digitale Anwendung

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• New Healthcare Approach

Interventions

Type	Name	Description
BEHAVIORAL	Intervention	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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2022-08-16
• Last updated: 2024-11-22

Locations

1 site across 1 country: Germany