Evaluating the Effectiveness of an Unguided Digital Therapeutic for Breast Cancer Survivors – optimune – Randomized Controlled Trial

Evaluating the Effectiveness of an Unguided Digital Therapeutic for Breast Cancer Survivors – optimune – Randomized Controlled Trial - EvaBSo

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00028778

Enrollment

680

Registered

2022-04-11

Start date

2022-08-01

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: Intervention group: access to the online program optimune for 365 days - in addition to routine treatment (care as usual). Group 2: Control group: routine treatment (care as usual), access to

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Diagnosis of breast cancer (ICD-10: C50, confirmed by a physician's letter or equivalent). - Completed acute breast cancer treatment (e.g., surgery, chemotherapy, radiation therapy). - Impaired quality of life (AQoL-8D = 73.3%). - Informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: - Patients with life expectancy of less than three months

Design outcomes

Primary

Measure	Time frame
Quality of life (total score Assessment of Quality of Life; AQoL-8D) at T1 (3 months after baseline).	—

Secondary

Measure	Time frame
- General distress (Depression-Anxiety-Stress-Scales, DASS-21) - Work and social ability (Work and Social Adjustment Scale, WSAS) - Fatigue (Brief Fatigue Inventory, BFI) - responder rate of AQoL-8D - Subscales and dimensions of AQoL-8D	—

Countries

Germany

Contacts

Public ContactLinda Betz

GAIA AG

team@optimune-studie.de+49 40-349930 144

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026