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PRISMA – A pilot randomized phase II trial on social prescriptions and micro learning to improve care for cancer patients and their support persons

PRISMA – A pilot randomized phase II trial on social prescriptions and micro learning to improve care for cancer patients and their support persons - PRISMA

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00039847
Enrollment
384
Registered
2026-04-13
Start date
2026-04-15
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Malignant melanoma, Colorectal carcinoma, Hematologic neoplasms, Lung cancer

Interventions

Group 1: Intervention arm: Participants in the intervention arm receive a complex supportive care intervention in addition to usual care. The intervention includes a social prescription with individua

Sponsors

Universität Regensburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) diagnosis of early-stage or advanced-stage lung cancer, colorectal cancer, hematological neoplasm or malignant melanoma 2) primary diagnosis within the past 12 months 3) expected survival of at least 18 months 4) attendance at the medical oncology units of participating hospitals 5) ECOG Performance Status 0-2 6) sufficient German language proficiency to complete questionnaires and interviews 7) ability to name an eligible SP 8) provision auf written informed cosent

Exclusion criteria

Exclusion criteria: 1) inability to provide informed consent 2) inability independently complete interviews and/or questionnaires due to impaired speech, vigilance, or comprehension.

Design outcomes

Primary

MeasureTime frame
Quality of life at 6 months after baseline, measured using the global health score of the EORTC QLQ-F17. Quality of life will also be assessed at baseline, 4 weeks, 3 months, and 12 months for longitudinal analyses.

Secondary

MeasureTime frame
Self-efficacy, assessed using the Cancer Behavior Inventory Brief Version (CBI-B-D-12). Knowledge of health and care, measured using self-developed items. Healthcare utilization and supportive care use, measured by the number of hospital admissions, length of hospital stays, and documentation of supportive care services.

Countries

Germany

Contacts

Public ContactChristine Bernardi

Universität Regensburg, Institut für Epidemiologie und Präventivmedizin, Medizinische Soziologie

christine.bernardi@ukr.de+49 941 944-5236

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026