Effectiveness of mobile application-based cognitive-behavioural therapy in women treated for breast cancer: a randomized controlled pilot study in Germany

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00029918

Enrollment

Registered

2022-07-29

Start date

2022-07-27

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C50

Interventions

Group 1: Standard psycho-oncological care in combination with mobile application-based cognitive-behavioural therapy “Living Well” Group 2: Standard psycho-oncological care

Eligibility

Sex/Gender

Female

Age

18 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Anxiety and depression after 12 ± 1 weeks measured by the Hospital Scale of Anxiety and Depression (HADS).	—

Secondary

Measure	Time frame
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.	—

Countries

Germany

Contacts

Public ContactGeorgia Schilling

Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona

g.schilling@asklepios.com015123550058

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 5, 2026