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Integrative care model for cancer patients with migration related language barrier

Integrative care model for cancer patients with migration related language barrier - IntVeM

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034749
Enrollment
126
Registered
2024-12-06
Start date
2024-12-06
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Cancer patients with a migration related language barrier and follwing cancer diagnosis: Esophageal, stomach cancer, bronchial carcinoma, gynecological and head-neck tumors, hematological neoplasms

Interventions

Group 1: Adults with a migration background and language barriers (first language: Arabic, Russian, Turkish, Ukrainian), who are being hospitalized for the first time at the University Hospital of Col

Sponsors

Institut für Pflegewissenschaft, Universität zu Köln, Medizinische Fakultät und Uniklinik Köln
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: There is a migration-related language barrier, as assessed by the treatment team. The patients' native languages are Arabic, Russian, Turkish, or Ukrainian. Additionally, patients have a confirmed diagnosis of the following cancers: esophageal cancer, stomach cancer, bronchial carcinoma, gynecological tumors, head-neck tumors, or hematological neoplasms. The start of treatment at the University Hospital of Cologne should be no more than one month ago. Only patients treated in one of the participating wards of the University Hospital of Cologne (n=9) will be included Relatives and associates of the patients included in the intervention (control group and intervention group). For the control group, n=28, and for the intervention group, n=56. For the process evaluation: care providers and additional stakeholders who will be identified over the course of the study. Participation of employees from University Hospital Cologne also requires the approval of the relevant staff council.

Exclusion criteria

Exclusion criteria: Therapy initiation more than 1 month ago, patients under 18 years of age, treatment outside the designated wards/clinics, severely reduced general condition, patients with low literacy, patients lacking the capacity to give consent, patients with a planned stay of less than 72 hours

Design outcomes

Primary

MeasureTime frame
The primary endpoints are the support needs and problem coping of the patients. Three assessment time points are planned. T0 occurs upon study inclusion within the first 72 hours of the hospital stay. T1 occurs a maximum of 72 hours before discharge from the same hospital stay. T2 occurs three months after T1. For the assessments, the following instruments are planned at the specified time points: Patient Self-Report Health Literacy (PSR-HealLit): Psychosocial Risks: T0, T1, T2

Secondary

MeasureTime frame
The assessment time points for the following secondary endpoints correspond to those of the primary endpoints (T0, T1, T2): Informedness: Visual Analogue Scale (VAS): T0, T1, T2 Therapy adherence: Brief Adherence Assessment (BAA): T1, T2 Involvement in the therapy process (Shared Decision Making): collaboRATE: T1, T2 Informed decisions: Control Preference Scale - post (CPS-post): T1, T2 Autonomy preference: Control Preference Scale (CPS): T1, T2 Quality of life: EuroQol-5 Dimensions (EQ-5D): T0, T1, T2 Anxiety: Hospital Anxiety and Depression Score - Anxiety (HADS-A): T0, T1, T2 Satisfaction: Visual Analogue Scale (VAS): T0, T1, T2 Number of emergency presentations & therapy discontinuations: Self-reports and patient records Process Evaluation: Focus groups and individual interviews with patients, relatives and close associates, care providers, and management staff. Effectiveness of Implementation: Modified Promoting Action on Research Implementation in Health Services (Mi-PARiHS)

Countries

Germany

Contacts

Public ContactJohannes Bösche

Uniklinik Köln

johannes.boesche@uk-koeln.de0221-478 77272

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Sep 3, 2026