Evaluation of medical benefits and positive effects of the certified medical product PINK! Coach in a multi-centre, randomized controlled clinical study with breast cancer patients
Organizational Data
- DRKS-ID:
- DRKS00028699
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2022-08-29
- Last update in DRKS:
- 2024-01-26
- Registration type:
- Prospective
Acronym/abbreviation of the study
PINK! Coach
URL of the study
No Entry
Brief summary in lay language
A multi-centre RCT to investigate the medical and economic benefits of the digital health application PINK! Coach. It is assumed that the use of the PINK! Coach for therapy and aftercare support for patients with breast cancer (EBC and MBC) leads to a significant reduction in psychological stress and other secondary endpoints.
Brief summary in scientific language
Multicentric, prospective RCT to investigate the medical benefits and economic endpoints to evaluate the digital health application PINK! Coach for patients with early and advanced breast cancer during initial therapy and aftercare.
Health condition or problem studied
- Free text:
- mamma carcinoma
- ICD10:
- C50 - Malignant neoplasm of breast
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- using PINK! Coach: Intervention group receives the App for 12 months. After reaching the primary outcome after 3 months, the control group receives the App, which means 9 months of usage. Both is meant to be until the end of this study.
- Arm 2:
- standard of care
Endpoints
- Primary outcome:
- PHQ-9 sum score to the following points of time: - Baseline (zum Rekrutierungszeitpunkt) - T1 (after 4 weeks) - T2 (after 8 weeks) - T3 (after 12 weeks) - T4 (longtime followup after 6 months) - T5 (longtime followup after12 months)
- Secondary outcome:
- health-related quality of life, physical activity, resilience, fatigue: - Baseline (at the time of recruitment) - T1 (after 4 weeks) - T2 (after 8 weeks) - T3 (after 12 weeks) - T4 (longtime followup after 6 months) - T5 (longtime followup after 12 months) health literacy: - Baseline (at the time of recruitment) - T3 (after 12 weeks) BMI: - Baseline (at the time of recruitment) - T2 (after 8 weeks) - T3 (after 12 weeks) - T4 (longtime followup after 6 months) - T5 (longtime followup after 12 months) economic endpoints - Baseline (at the time of recruitment) - T3 (after 12 weeks) - T5 (longtime followup after 12 months)
Study Design
- Purpose:
- Supportive care
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- IV
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center LMU Brustzentrum München München
- Medical center KEM Kliniken Senologie Essen Essen
- University medical center Brustzentrum UKM Münster Münster
- Medical center Agaplesion Markus Krankenhaus Klinik für Gynäkologie und Gynäkologische Onkologie Frankfurt Frankfurt am Main
- Medical center Kooperatives Brustzentrum Paderborn -Gynäkologisches Krebszentrum am St. Vincenz Paderborn
- Medical center St. Elisabeth-Krankenhaus Köln-Hohenlind Köln
- University medical center Universitätsfrauenklinik am Caritas-Krankenhaus St. Josef Regensburg
Recruitment period and number of participants
- Planned study start date:
- 2022-09-15
- Actual study start date:
- 2022-09-23
- Planned study completion date:
- 2024-02-26
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 422
- Final Sample Size:
- 434
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- age > 18 years German speaking Histologically proven breast cancer (all stages, TNM classifications, therapies) Diagnosis of the initial disease, recurrence, metastasis within the last 6 months In initial therapy (at least 6 weeks left at the time of recruitment) or discharge for aftercare at the time of recruitment owning a smartphone willingness to use PINK! Coach regularly existence of an e-mail address
Exclusion Criteria
Estimated survival < 3 months Use of another app to accompany cancer therapy or aftercare
Addresses
Primary Sponsor
- Address:
- PINK gegen Brustkrebs GmbHProf. Dr. Pia WülfingCurschmannstr. 3520251 HamburgGermany
- Telephone:
- +49 40 468 9808 63
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.pink-brustkrebs.de/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Brustzentrum LMU München Leitung Brustzentrum LMU München Klinik und Poliklinik für Frauenheilkunde und GeburtshilfePD Dr. med. Rachel WürstleinZiemssenstr. 180336 MünchenGermany
- Telephone:
- +49 089 4400 54110
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.lmu-klinikum.de/brustzentrum
Contact for Public Queries
- Address:
- Frauenklinik Brustzentrum LMU MünchenSvenja SeidelMarchioninistraße 1581377 MünchenGermany
- Telephone:
- +49 089/4400-77994
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://klinikum.uni-muenchen.de
Principal Investigator
- Address:
- Brustzentrum LMU München Leitung Brustzentrum LMU München Klinik und Poliklinik für Frauenheilkunde und GeburtshilfePD Dr. med. Rachel WürstleinZiemssenstr. 180336 MünchenGermany
- Telephone:
- +49 089 4400 54110
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.lmu-klinikum.de/brustzentrum
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- PINK gegen Brustkrebs GmbHCurschmannstr. 3520251 HamburgGermany
- Telephone:
- +49 40 468 9808 63
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.pink-brustkrebs.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Med. Fakultät der LMUPettenkoferstraße 880336 MünchenGermany
- Telephone:
- +49-89-440055191
- Fax:
- +49-89-440055192
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-05-10
- Ethics committee number:
- 22-0498
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-07-21
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- DRKS00025811 - Pilotstudie
Publication of study results
- Planned publication:
- 2023
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry