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

NCT ID: NCT05503160

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2026-06-30

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.

Conditions

New Healthcare Approach

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Intervention

Intervention Type: BEHAVIORAL

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.

Control

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal Joint Committee

OTHER_GOV

Sponsor Role: collaborator

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marion Kiechle, Prof. Dr. med.

Role: STUDY_DIRECTOR

Technical University of Munich

Locations

Klinikum rechts der Isar, Frauenklinik, Technische Universität München

Munich, Germany, Germany

Countries

Germany

Other Identifiers

PRISMA

Identifier Type: -

Identifier Source: org_study_id