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

Phase 4

• Conditions: C50; Malignant neoplasm of breast

• Registration Number: DRKS00028778
• Lead Sponsor: GAIA AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: Female
• Target Recruitment: 405

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

- Patients with life expectancy of less than three months

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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