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New Healthcare ApproachPRISMANCT05503160

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

A study testing Intervention in people with New Healthcare Approach, run by Technical University of Munich at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
New Healthcare Approach
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteGermany
Study dates
1 Jan 2022to Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinikum rechts der Isar, Frauenklinik, Technische Universität München

    Munich, Germany, 81675

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
Intervention
Keywords
quality of life, adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionBehavioural

    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.

Study groups in NCT05503160
Study groupRoleWhat they receive
InterventionActive comparatorWith 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.
Receives: Behavioral: Intervention
ControlNo interventionStandard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life (QOL)

    Change in EORTC QLQ-C30 subscale

    Measured: 24 Months

Secondary outcomes (18)

  1. Quality of Life (QOL)

    Change in EORTC QLQ-BR23

    Measured: 24 Months

  2. Quality of Life (QOL)

    Change in EORTC QLQ-BR23

    Measured: 6, 12, 18 Months

  3. Quality of Life (QOL)

    Change in EORTC QLQ-C30

    Measured: 6, 12, 18 Months

  4. Adherence

    Number of days missing tablets

    Measured: 24 Months

  5. Mental health

    Change in GAD-2

    Measured: 24 Months

  6. Mental health

    Change in Distress thermometer

    Measured: 24 Months

  7. Mental health

    Change in PHQ-2

    Measured: 24 Months

  8. Adverse effect of therapy

    Count of side effects cat. 3/4

    Measured: 24 Months

  9. Assessment of new digital form of care

    Usefulness of application

    Measured: 24 Months

  10. Progression free survival

    PFS rate

    Measured: 24 Months

  11. Overal survival

    OS rate

    Measured: 24 Months

  12. Total cost

    Cost difference

    Measured: 24 Months

  13. Disease-specific costs

    Cost difference

    Measured: 24 Months

  14. Effectiveness (QOL)

    Change in EORTC QLQ-C30 subscale

    Measured: 24 Months

  15. Efficiency (QALY)

    Qaly-Index from EQ-5D-5L

    Measured: 24 Months

  16. Patient Satisfaction

    Short Assessment of Patient Satisfaction - Satisfaction Index

    Measured: 6, 24 Months

  17. Stakeholder perspective

    Stakeholder perspective questionnaires

    Measured: 12, 24 Months

  18. Number of Interventions

    Automatically initiated reasons for interventions

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2022
  2. Study start1 Jan 2022
  3. Primary completionDec 2025 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05503160
Sponsor's protocol ID
PRISMA
Acronym
PRISMA
Status last verified
Nov 2024
First submitted
8 Aug 2022
Last updated
22 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with New Healthcare Approach, run by Technical University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life (QOL) (time frame: 24 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05503160.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.

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