A Randomized, Experimental Evaluation Study of the Patient-Related, Medical, and Health Care Benefits of the Digital Therapy Companion TINO DTB (Therapy In Oncology Digital Therapy Companion).
Not Applicable
Not yet recruiting
- Conditions
- Lower-inner quadrant of breastC50.5C50.6C50.8C50.9C34.0C34.1C34.2C34.3C34.8
- Registration Number
- DRKS00025491
- Lead Sponsor
- DTB Gesellschaft für digitale Therapiebegleitung mbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 320
Inclusion Criteria
Any of the following oncologic indications: Malignant neoplasm of the mammary gland (BC; ICD-10 code: C50.-), Malignant neoplasm of the bronchi and lungs (LC; ICD-10 code: C34.-), Multiple myeloma (MM; ICD-10 code: C90. 0); restart of oral systemic oncology therapy, minimum age: 18 years, signed Informed Consent (IC) at baseline, physician assessment of whether the patient is able to use the Tino DTB application.
Exclusion Criteria
No oral cancer therapy. Under age.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HrQoL (EORTC QLQ-C30© - Global health status/QoL) over the three-month period after starting therapy (medical benefit).
- Secondary Outcome Measures
Name Time Method Change in HrQoL (EORTC QLQ-C30©) over the six-month period after therapy start (medical benefit) (change in Global health status/QoL; change in functional subscales; change in symptom subscales/items).<br><br>Change in patient-reported adherence over the six-month period after therapy initiation (structural benefit).<br><br>Time to discontinuation of therapy due to an adverse event/adverse event (AE) over the six-month period after initiation of therapy (medical benefit), rate of overall survival at six months (medical benefit), rate of progression-free survival at six months (medical benefit).