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

NCT05503160 | Active Not Recruiting DMC

• 1 other identifier: PRISMA
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

New Healthcare Approach

Keywords

quality of life; adherence

Outcome Measures

Primary Outcomes (1)

• Quality of Life (QOL)

  Change in EORTC QLQ-C30 subscale

  24 Months

Secondary Outcomes (18)

• Quality of Life (QOL)

  24 Months

• Quality of Life (QOL)

  6, 12, 18 Months

• Quality of Life (QOL)

  6, 12, 18 Months

• Adherence

  24 Months

• Mental health

  24 Months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Standard of care

Interventions

Intervention 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• no use of internet or digital applications
• advanced, metastatic breast cancer
• simultaneous serious disease
• life expectancy \< 2 years

Sponsors & Collaborators

• Technical University of Munich: lead
• Federal Joint Committee: collaborator

Study Sites (1)

Klinikum rechts der Isar, Frauenklinik, Technische Universität München

Munich, Germany, 81675, Germany

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Marion Kiechle, Prof. Dr. med.

  Technical University of Munich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 16, 2022
• Study Start: January 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: June 1, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

DE (1)