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Social Prescriptions and Micro-Learning to Improve Care for Cancer Patients and Their Support Persons (PRISMA)

24. august 2026 oppdatert av: Anne Herrmann, University of Regensburg

PRISMA - A Pilot Randomized Phase II Trial on Social Prescriptions and Micro- Learning to Improve Care for Cancer Patients and Their Support Persons

Optimal patient-centered care is often not being delivered to cancer patients, especially to vulnerable populations like those living in underserved rural areas. This body of work will develop and pilot test a multicomponent intervention approach designed to improve the care and outcomes of cancer patients and their support persons (SPs) during and following their therapeutic journey. The intervention will involve the provision of social prescriptions and web-based micro-learning modules, as well as stepwise care based on ongoing monitoring of symptom burden and health. This project uses the strengths of innovative, individually tailored communication strategies and a comprehensive low-cost approach that are likely to support fair and equal patient access to optimal care beyond the funding period. By using a patient-driven approach in an interdisciplinary setting, it is anticipated that the intervention will improve the health outcomes of various patient populations, especially those living in rural areas. To achieve this, a methodologically robust mixed-methods approach and an effectiveness-implementation hybrid design will be employed to move effective strategies towards implementation into clinical practice. A number of standardized patient-reported outcome and experience measures will be used, including quality of life and knowledge of health and care. As a result of this research, an implementation toolbox will be developed that could be used by clinicians working in different healthcare settings and services, both nationally and internationally, to help provide highest quality cancer care.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

384

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Tyskland
      • Bayreuth, Tyskland
        • Aktiv, ikke rekrutterende
        • Faculty of Law, Business & Economics, Inst. for Healthcare Management & Health Sciences
      • Berlin, Tyskland
        • Har ikke rekruttert ennå
        • Charité - University Medicine Berlin
        • Ta kontakt med:
        • Hovedetterforsker:
          • Susanne Rittig, Dr
      • Cologne, Tyskland
    • Bavaria
      • Augsburg, Bavaria, Tyskland
        • Har ikke rekruttert ennå
        • University Hospital Augsburg
        • Ta kontakt med:
      • Erlangen, Bavaria, Tyskland
        • Har ikke rekruttert ennå
        • University Hospital Erlangen
        • Ta kontakt med:
      • Regensburg, Bavaria, Tyskland, 93053
        • Rekruttering
        • University Hospital Regensburg
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tobias Pukrop, Prof Dr
        • Hovedetterforsker:
          • Daniel Heudobler, Prof Dr
        • Underetterforsker:
          • Daniel Wolff, Prof Dr
        • Underetterforsker:
          • Kathrin Reuthner
        • Underetterforsker:
          • Michael Koller, Prof Dr
        • Underetterforsker:
          • Florian Zeman
      • Regensburg, Bavaria, Tyskland, 93053
        • Aktiv, ikke rekrutterende
        • University Regensburg
      • Würzburg, Bavaria, Tyskland
        • Har ikke rekruttert ennå
        • University Hospital Würzburg
        • Ta kontakt med:
          • Hermann Einsele, Prof Dr
          • Telefonnummer: +49 931 201-40001
          • E-post: einsele_h@ukw.de
        • Hovedetterforsker:
          • Imad Maatouk, Prof Dr

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria for patients:

  • aged at least 18 years
  • primary diagnosis of early-stage or advanced-stage lung cancer, colorectal cancer, hematological neoplasm or malignant melanoma within the past 12 months
  • expected survival of at least 18 months
  • sufficient German language proficiency to complete questionnaires and interviews
  • attendance at the medical oncology units of participating hospitals
  • provision of written informed consent
  • ECOG Performance Status 0-2
  • ability to name an eligible SP.

Inclusion criteria for Support Persons:

  • being nominated by the patient as someone who provides support, encouragement or assistance in coping with their cancer
  • aged at least 18 years
  • proficiency in German
  • provision of written informed consent.

Exclusion Criteria:

Inability to

  • provide informed consent
  • independently complete interviews and/or questionnaires due to impaired speech, vigilance, or comprehension.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: styre
Eksperimentell: innblanding
Annen: PRISMA-interventions
A multicomponent intervention including social prescriptions, web-based micro-learning modules, and stepwise care based on symptom monitoring.
Andre navn:
  • Social prescription
  • Micro-learning
  • Monitoring (stepwise care)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Functioning, 17 items (EORTC QLQ-F17)
Tidsramme: From enrollment to the use of treatment at 4 weeks, 3 months, 6 months and 12 months
Quality of life of patient and support person is obtained using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Functioning, 17 items (EORTC QLQ-F17). Scores range from 0 to 100, with higher scores indicating better functioning/quality of life.
From enrollment to the use of treatment at 4 weeks, 3 months, 6 months and 12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cancer Behavior Inventory Brief Version (CBI-B-D-12)
Tidsramme: From enrollment to the use of treatment at 4 weeks and 3,6 and 12 months
Self-efficacy is measured as secondary outcome using the Cancer Behavior Inventory Brief Version (CBI-B-D-12), with total scores ranging from 12 to 108, where higher scores indicate greater self-efficacy.
From enrollment to the use of treatment at 4 weeks and 3,6 and 12 months
self-developed items on knowledge of health and care
Tidsramme: From enrollment to the use of treatment at 4 weeks and 3,6 and 12 months
Knowledge of health and care is measured as a secondary outcome using self-developed items. Items were developed based on a literature review, and were reviewed, refined, and pilot-tested with the PRISMA Patient Advisory Board.
From enrollment to the use of treatment at 4 weeks and 3,6 and 12 months
Healthcare Utilization (Care Level, Hospital Admissions, Length of Stay, Supportive Care Services)
Tidsramme: From enrollment to the use of treatment at 4 weeks and 3, 6 and 12 months
Healthcare utilization will be assessed by patients' need for long-term care (care level), number of hospital admissions and length of hospital stays (both obtained from hospital records), and documentation of supportive care services (assessed using self-developed items based on standardized instruments).
From enrollment to the use of treatment at 4 weeks and 3, 6 and 12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Regensburg

Samarbeidspartnere

Charite University, Berlin, Germany
Wuerzburg University Hospital
University Hospital Erlangen
University Hospital Regensburg
Universitätsklinikum Köln
University Hospital Augsburg

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. april 2026

Primær fullføring (Antatt)

30. november 2028

Studiet fullført (Antatt)

30. november 2028

Datoer for studieregistrering

Først innsendt

19. august 2026

Først innsendt som oppfylte QC-kriteriene

24. august 2026

Først lagt ut (Faktiske)

26. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Z-2026-2552-5 (Annet stipend/finansieringsnummer: Nationales Centrum für Tumorerkrankungen (NCT))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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