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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: New Healthcare Approach
• Intervention / Treatment: Behavioral: Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 81675
    • Klinikum rechts der Isar, Frauenklinik, Technische Universität München

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of care
Active Comparator: Intervention; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (QOL)	Change in EORTC QLQ-C30 subscale	24 Months

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Federal Joint Committee
• Investigators: Study Director: Marion Kiechle, Prof. Dr. med., Technical University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; adherence
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: PRISMA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No