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).

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). - TINO-DTB DiGA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025491

Enrollment

320

Registered

2021-06-21

Start date

2021-10-15

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

C50.0 C50.1 C50.2 C50.3 C50.4 C50.5 C50.6 C50.8 C50.9 C34.0 C34.1 C34.2 C34.3 C34.8 C34.9 C90.0

Interventions

Group 1: Patients in the intervention group will receive the Digital Therapy Companion Tino DTB in addition to routine care. Group 2: The control group will be treated in the same way as the interven

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: No oral cancer therapy. Under age.

Design outcomes

Primary

Measure	Time frame
Change in HrQoL (EORTC QLQ-C30© - Global health status/QoL) over the three-month period after starting therapy (medical benefit).	—

Secondary

Measure	Time frame
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). Change in patient-reported adherence over the six-month period after therapy initiation (structural benefit). 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).	—

Measure

Time frame

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). Change in patient-reported adherence over the six-month period after therapy initiation (structural benefit). 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).

—

Countries

Germany

Contacts

Public ContactChristoph Riese

DTB Gesellschaft für digitale Therapiebegleitung mbH

info@digitale-therapiebegleitung.de+49 171 1926734

Outcome results

None listed

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