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Evaluation of medical benefits and positive effects on patient supply of the certified medical product PINK! Leben in a multi-centre, randomized controlled trial with breast cancer patients

Organizational Data

DRKS-ID:
DRKS00031243
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2023-03-07
Last update in DRKS:
2023-03-07
Registration type:
Prospective

Acronym/abbreviation of the study

PINK! Leben

URL of the study

No Entry

Brief summary in lay language

PINK! Leben is a psycho-oncological online course to support patients with breast cancer during therapy and aftercare. The medical benefits of the course are to be researched.

Brief summary in scientific language

The intervention group uses PINK! Leben maximum 8 weeks (and at least 4 weeks). We expect a significantly reduction compared to the control group of anxiety and depression symptoms, measured with the validated questionnaire HADS.

Health condition or problem studied

ICD10:
C50 - Malignant neoplasm of breast
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
intervention group uses PINK! Leben course Completing the psycho-oncological online course PINK! Leben with tablet, laptop or computer. The course is subdivided into 4 modulus, that are based on acceptance and commitment therapy.
Arm 2:
Control group - waiting list - comparison to standard of care - get access to PINK! Leben after 8 weeks

Endpoints

Primary outcome:
HADS summ score at 2,4,6 and 8 weeks (primary endpoint) ar 3, 6 and 12 months (Follow-up)
Secondary outcome:
Fatigue (BFI) RS-13 (Resiliece) PA-F (fear of recurrence) VAS-Skala aus EQ-5D (QoL) HADS-A (Anxiety) HADS-D (Depression)

Study Design

Purpose:
Supportive care
Allocation:
Randomized controlled study
Control:
  • Other
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
stratified randomization 1:1 control:intervention
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting planned
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center KMG Klinik Silbermühle Plau am See - Rehaklinik für Kardiologie und Onkologie Plau am See
  • Medical center AMEOS Klinikum Ratzeburg Ratzeburg

Recruitment period and number of participants

Planned study start date:
2023-03-28
Actual study start date:
No Entry
Planned study completion date:
2024-05-28
Actual Study Completion Date:
No Entry
Target Sample Size:
194
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
German speaking Proof of the diagnosis of a histologically confirmed breast carcinoma willingness to accept the PINK! complete the life course Willingness to fill out online questionnaires (8 in total) Presence of an email address Presence of a laptop / computer / tablet Therapy situation: (1) still at least 8 weeks in therapy (2) OR discharge for aftercare (outpatient) (up to 6 months after the end of therapy) (3) OR upon commencement of 3 or 4 week inpatient rehabilitation

Exclusion Criteria

Planned psycho-oncological care during therapy or rehabilitation Use of another app / online course to reduce psychological stress (also PINK! Coach) Strong previous psychological stress: currently severe depression (F32.2, F32.3, F33.2, F33.3, possibly also F31.4, F31.5), acute suicidality (no ICD diagnosis, as symptom R45.8 , Z91.8)

Addresses

Primary Sponsor

PINK! gegen Brustkrebs
20251 Hamburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

KMG Klinikum Plau am See
PD Dr. Andreas-Claudius Hoffmann
Millionenweg 24
19395 Plau am See
Germany
Telephone:
038735 880
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

KMG Klinikum Plau am See
PD Dr. Andreas-Claudius Hoffmann
Millionenweg 24
19395 Plau am See
Germany
Telephone:
038735 880
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

KMG Klinikum Plau am See
PD Dr. Andreas-Claudius Hoffmann
Millionenweg 24
19395 Plau am See
Germany
Telephone:
038735 880
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

PINK! gegen Brustkrebs GmbH
20251 Hamburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission an der Medizinischen Fakultät der Universität Rostock im Institut für Rechtsmedizin
St.-Georg-Str. 108
18055 Rostock
Germany
Telephone:
+49-381-4949904
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2023-02-03
Ethics committee number:
A2023-0028
Vote of the Ethics Committee:
Approved
Date of the vote:
2023-02-27

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED 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:
No Entry

Publication of study results

Planned publication:
No Entry
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