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NCT Number: NCT05503160

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum rechts der Isar, Frauenklinik, Technische Universität München

Munich, Germany, 81675

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Quality of Life (QOL)

    Time frame: 24 Months

    Change in EORTC QLQ-C30 subscale

Secondary outcomes

  1. Quality of Life (QOL)

    Time frame: 24 Months

    Change in EORTC QLQ-BR23

  2. Quality of Life (QOL)

    Time frame: 6, 12, 18 Months

    Change in EORTC QLQ-BR23

  3. Quality of Life (QOL)

    Time frame: 6, 12, 18 Months

    Change in EORTC QLQ-C30

  4. Adherence

    Time frame: 24 Months

    Number of days missing tablets

  5. Mental health

    Time frame: 24 Months

    Change in GAD-2

  6. Mental health

    Time frame: 24 Months

    Change in Distress thermometer

  7. Mental health

    Time frame: 24 Months

    Change in PHQ-2

  8. Adverse effect of therapy

    Time frame: 24 Months

    Count of side effects cat. 3/4

  9. Assessment of new digital form of care

    Time frame: 24 Months

    Usefulness of application

  10. Progression free survival

    Time frame: 24 Months

    PFS rate

  11. Overal survival

    Time frame: 24 Months

    OS rate

  12. Total cost

    Time frame: 24 Months

    Cost difference

  13. Disease-specific costs

    Time frame: 24 Months

    Cost difference

  14. Effectiveness (QOL)

    Time frame: 24 Months

    Change in EORTC QLQ-C30 subscale

  15. Efficiency (QALY)

    Time frame: 24 Months

    Qaly-Index from EQ-5D-5L

  16. Patient Satisfaction

    Time frame: 6, 24 Months

    Short Assessment of Patient Satisfaction - Satisfaction Index

  17. Stakeholder perspective

    Time frame: 12, 24 Months

    Stakeholder perspective questionnaires

  18. Number of Interventions

    Time frame: 24 Months

    Automatically initiated reasons for interventions

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Federal Joint Committee

Registry information

Official study title

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

Acronym: PRISMA

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Aug 16, 2022
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.