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

Primary Purpose

New Healthcare Approach

Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Intervention
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for New Healthcare Approach focused on measuring quality of life, adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Klinikum rechts der Isar, Frauenklinik, Technische Universität München

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Control

Arm 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.

Standard of care

Outcomes

Primary Outcome Measures

Quality of Life (QOL)
Change in EORTC QLQ-C30 subscale

Secondary Outcome Measures

Quality of Life (QOL)
Change in EORTC QLQ-BR23
Quality of Life (QOL)
Change in EORTC QLQ-BR23
Quality of Life (QOL)
Change in EORTC QLQ-C30
Adherence
Number of days missing tablets
Mental health
Change in GAD-2
Mental health
Change in Distress thermometer
Mental health
Change in PHQ-2
Adverse effect of therapy
Count of side effects cat. 3/4
Assessment of new digital form of care
Usefulness of application
Progression free survival
PFS rate
Overal survival
OS rate
Total cost
Cost difference
Disease-specific costs
Cost difference
Effectiveness (QOL)
Change in EORTC QLQ-C30 subscale
Efficiency (QALY)
Qaly-Index from EQ-5D-5L
Patient Satisfaction
Short Assessment of Patient Satisfaction - Satisfaction Index
Stakeholder perspective
Stakeholder perspective questionnaires
Number of Interventions
Automatically initiated reasons for interventions

Full Information

First Posted
August 8, 2022
Last Updated
October 28, 2022
Sponsor
Technical University of Munich
Collaborators
Federal Joint Committee
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1. Study Identification

Unique Protocol Identification Number
NCT05503160
Brief Title
Primary Hormone-sensitive Breast Cancer: Need-driven Health Care Improvement by Patient-centred Digital Application
Acronym
PRISMA
Official Title
Primäres Hormon-Sensitives Mammakarzinom: Bedarfsgerechte Optimierung Der Versorgung Durch Eine Patientenzentrierte, Digitale Anwendung
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
Collaborators
Federal Joint Committee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
New Healthcare Approach
Keywords
quality of life, adherence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
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 Outcome Measure Information:
Title
Quality of Life (QOL)
Description
Change in EORTC QLQ-C30 subscale
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Quality of Life (QOL)
Description
Change in EORTC QLQ-BR23
Time Frame
24 Months
Title
Quality of Life (QOL)
Description
Change in EORTC QLQ-BR23
Time Frame
6, 12, 18 Months
Title
Quality of Life (QOL)
Description
Change in EORTC QLQ-C30
Time Frame
6, 12, 18 Months
Title
Adherence
Description
Number of days missing tablets
Time Frame
24 Months
Title
Mental health
Description
Change in GAD-2
Time Frame
24 Months
Title
Mental health
Description
Change in Distress thermometer
Time Frame
24 Months
Title
Mental health
Description
Change in PHQ-2
Time Frame
24 Months
Title
Adverse effect of therapy
Description
Count of side effects cat. 3/4
Time Frame
24 Months
Title
Assessment of new digital form of care
Description
Usefulness of application
Time Frame
24 Months
Title
Progression free survival
Description
PFS rate
Time Frame
24 Months
Title
Overal survival
Description
OS rate
Time Frame
24 Months
Title
Total cost
Description
Cost difference
Time Frame
24 Months
Title
Disease-specific costs
Description
Cost difference
Time Frame
24 Months
Title
Effectiveness (QOL)
Description
Change in EORTC QLQ-C30 subscale
Time Frame
24 Months
Title
Efficiency (QALY)
Description
Qaly-Index from EQ-5D-5L
Time Frame
24 Months
Title
Patient Satisfaction
Description
Short Assessment of Patient Satisfaction - Satisfaction Index
Time Frame
6, 24 Months
Title
Stakeholder perspective
Description
Stakeholder perspective questionnaires
Time Frame
12, 24 Months
Title
Number of Interventions
Description
Automatically initiated reasons for interventions
Time Frame
24 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heike Jansen, Dr. med.
Phone
+49-89-4140-2420
Email
heike.jansen@tum.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion Kiechle, Prof. Dr. med.
Organizational Affiliation
Technical University of Munich
Official's Role
Study Director
Facility Information:
Facility Name
Klinikum rechts der Isar, Frauenklinik, Technische Universität München
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heike Jansen, Dr. med.
Phone
+49-89-4140-2420
Email
heike.jansen@tum.de
First Name & Middle Initial & Last Name & Degree
Marion Kiechle, Prof. Dr. med.
Phone
+49-89-4140-2420
Email
marion.kiechle@tum.de

12. IPD Sharing Statement

Learn more about this trial

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

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