ClinicalTrials.Veeva

Menu

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

T

Technical University of Munich

Status

Active, not recruiting

Conditions

New Healthcare Approach

Treatments

Behavioral: Intervention

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

400 participants in 2 patient groups

Intervention
Active Comparator group
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.
Treatment:
Behavioral: Intervention
Control
No Intervention group
Description:
Standard of care

Trial contacts and locations

1

Loading...

Central trial contact

Heike Jansen, Dr. med.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems