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

Sponsor
Technische Universität München (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05503160
Collaborator
Federal Joint Committee (Other)
400
Enrollment
1
Location
2
Arms
33
Anticipated Duration (Months)
12.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intervention
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Primäres Hormon-Sensitives Mammakarzinom: Bedarfsgerechte Optimierung Der Versorgung Durch Eine Patientenzentrierte, Digitale Anwendung
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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.
No Intervention: Control

Standard of care

Outcome Measures

Primary Outcome Measures

  1. Quality of Life (QOL) [24 Months]

    Change in EORTC QLQ-C30 subscale

Secondary Outcome Measures

  1. Quality of Life (QOL) [24 Months]

    Change in EORTC QLQ-BR23

  2. Quality of Life (QOL) [6, 12, 18 Months]

    Change in EORTC QLQ-BR23

  3. Quality of Life (QOL) [6, 12, 18 Months]

    Change in EORTC QLQ-C30

  4. Adherence [24 Months]

    Number of days missing tablets

  5. Mental health [24 Months]

    Change in GAD-2

  6. Mental health [24 Months]

    Change in Distress thermometer

  7. Mental health [24 Months]

    Change in PHQ-2

  8. Adverse effect of therapy [24 Months]

    Count of side effects cat. 3/4

  9. Assessment of new digital form of care [24 Months]

    Usefulness of application

  10. Progression free survival [24 Months]

    PFS rate

  11. Overal survival [24 Months]

    OS rate

  12. Total cost [24 Months]

    Cost difference

  13. Disease-specific costs [24 Months]

    Cost difference

  14. Effectiveness (QOL) [24 Months]

    Change in EORTC QLQ-C30 subscale

  15. Efficiency (QALY) [24 Months]

    Qaly-Index from EQ-5D-5L

  16. Patient Satisfaction [6, 24 Months]

    Short Assessment of Patient Satisfaction - Satisfaction Index

  17. Stakeholder perspective [12, 24 Months]

    Stakeholder perspective questionnaires

  18. Number of Interventions [24 Months]

    Automatically initiated reasons for interventions

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Klinikum rechts der Isar, Frauenklinik, Technische Universität München Munich Germany 81675

Sponsors and Collaborators

  • Technische Universität München
  • Federal Joint Committee

Investigators

  • Study Director: Marion Kiechle, Prof. Dr. med., Technische Universität München

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT05503160
Other Study ID Numbers:
  • PRISMA
First Posted:
Aug 16, 2022
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Technische Universität München
quality of life
adherence
Additional relevant MeSH terms:
Hypersensitivity

Study Results

No Results Posted as of Aug 16, 2022