Effectiveness of mobile application-based cognitive-behavioural therapy in women treated for breast cancer: a randomized controlled pilot study in Germany
Organizational Data
- DRKS-ID:
- DRKS00029918
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2022-07-29
- Last update in DRKS:
- 2024-12-20
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
The study examines the effectiveness of standard treatment for breast cancer with support from mobile app-based cognitive behavioral therapy in women with breast cancer with respect to compared to standard treatment for cancer. Here, the effects of the treatments on depression and anxiety, emotional distress, health-related quality of life, and illness perception will be examined.
Brief summary in scientific language
Using a randomized control trial, the efficacy of standard treatment for oncologic disease supported by mobile app-based cognitive behavioral therapy in women with breast cancer compared to standard treatment for cancer will be examined with respect to the following outcomes: Depression and Anxiety (Hospital Scale of Anxiety and Depression (HADS)), Emotional Distress (Distress Thermometer), Health-Related Quality of Life (AQoL-8D), and Illness Perception (Brief Illness Perception Questionnaire (B-IPQ)).
Health condition or problem studied
- ICD-10-GM (translation):
- C50 - Malignant neoplasm of breast
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Standard psycho-oncological care in combination with mobile application-based cognitive-behavioural therapy “Living Well”
- Arm 2:
- Standard psycho-oncological care
Endpoints
- Primary outcome:
- Anxiety and depression after 12 ± 1 weeks measured by the Hospital Scale of Anxiety and Depression (HADS).
- Secondary outcome:
- Emotional distress using the Distress Thermometer after 12 ± 1 weeks, health-related quality of life using the AQoL-8D Assessment of Quality of Life (AQoL-8D) after 12 ± 1 weeks, illness perception using the Brief Illness Perception Questionnaire (B-IPQ) after 12 ± 1 weeks.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- 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 complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Asklepios Tumorzentrum Hamburg Hamburg
- Other HPZenner Clinical GmbH Tübingen
Recruitment period and number of participants
- Planned study start date:
- 2022-07-27
- Actual study start date:
- 2022-07-27
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2023-06-16
- Target Sample Size:
- 56
- Final Sample Size:
- 70
Inclusion Criteria
- Sex:
- Female
- Minimum Age:
- 18 Years
- Maximum Age:
- 75 Years
- Additional Inclusion Criteria:
- - Women with a diagnosis of primary cancer of breast (C50) - Active oncological treatment with the intention-to-treat (survival prognosis > 6 months) - Aged 18-75 years - Ability to read and write fluently in German - Ability to use the app (general suitability to use mobile applications) - Performance status assessment by using Eastern Cooperative Oncology Group (ECOG) score ≤ 2 - Informed consent to participate in the study and associated documentation
Exclusion Criteria
- Existing comorbidities that affect the mental health or quality of life (especially chronic illnesses: neurological, rheumatological, chronic pain, schizophrenia) - Current psychotherapeutic treatment aimed at depression, anxiety, and distress disorders - Other (digital or analogue) CBT therapy aimed at depression, anxiety, and distress disorders ongoing or in the two years prior - Lack of internet access/smartphone - Alcohol or drug abuse - Active psychotic symptoms - Suicidal tendencies - Impairment of vision which prevents the product from being used as intended - Severe cognitive impairments
Addresses
Primary Sponsor
- Address:
- Prosoma GmbHMarek OstrowskiKurfürstendamm 5010707 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Asklepios Tumorzentrum Hamburg, Asklepios Klinik AltonaDr. med. Georgia SchillingPaul-Ehrlich-Str. 122763 HamburgGermany
- Telephone:
- 015123550058
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Asklepios Tumorzentrum Hamburg, Asklepios Klinik AltonaDr. med. Georgia SchillingPaul-Ehrlich-Str. 122763 HamburgGermany
- Telephone:
- 015123550058
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Asklepios Tumorzentrum Hamburg, Asklepios Klinik AltonaDr. med. Georgia SchillingPaul-Ehrlich-Str. 122763 HamburgGermany
- Telephone:
- 015123550058
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Prosoma GmbHKurfürstendamm 5010707 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Ärztekammer HamburgWeidestraße 122 b22083 HamburgGermany
- Telephone:
- +49-40-2022990
- Fax:
- +40-40-202299410
- 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:
- 2022-02-04
- Ethics committee number:
- 2022-100789-BO-ff
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-04-29
Further identification numbers
- Other WHO Primary Registry or Data Provider 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:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publications/study results:
- Heinrich R, Schilling G, Wojtyna E, Arnold D, Geisler M, Kley S, Grudzinski P, Księżak M, Schoenfelder T. Effects of Mobile Application-Based Cognitive Behavioral Therapy on Psychological Outcomes in Women Treated for Breast Cancer: A Randomized Controlled Pilot Trial in Germany. Psychooncology. 2024 Oct;33(10):e70003. doi: 10.1002/pon.70003. PMID: 39439014.
- Date of the first journal publication of results:
- 2024-10-10
- DRKS entry published for the first time with results:
- 2024-12-20
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry