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

24 augusti 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

384

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Tyskland
      • Bayreuth, Tyskland
        • Aktiv, inte rekryterande
        • Faculty of Law, Business & Economics, Inst. for Healthcare Management & Health Sciences
      • Berlin, Tyskland
        • Har inte rekryterat ännu
        • Charité - University Medicine Berlin
        • Kontakt:
        • Huvudutredare:
          • Susanne Rittig, Dr
      • Cologne, Tyskland
    • Bavaria
      • Augsburg, Bavaria, Tyskland
        • Har inte rekryterat ännu
        • University Hospital Augsburg
        • Kontakt:
      • Erlangen, Bavaria, Tyskland
        • Har inte rekryterat ännu
        • University Hospital Erlangen
        • Kontakt:
      • Regensburg, Bavaria, Tyskland, 93053
        • Rekrytering
        • University Hospital Regensburg
        • Kontakt:
        • Huvudutredare:
          • Tobias Pukrop, Prof Dr
        • Huvudutredare:
          • Daniel Heudobler, Prof Dr
        • Underutredare:
          • Daniel Wolff, Prof Dr
        • Underutredare:
          • Kathrin Reuthner
        • Underutredare:
          • Michael Koller, Prof Dr
        • Underutredare:
          • Florian Zeman
      • Regensburg, Bavaria, Tyskland, 93053
        • Aktiv, inte rekryterande
        • University Regensburg
      • Würzburg, Bavaria, Tyskland
        • Har inte rekryterat ännu
        • University Hospital Würzburg
        • Kontakt:
          • Hermann Einsele, Prof Dr
          • Telefonnummer: +49 931 201-40001
          • E-post: einsele_h@ukw.de
        • Huvudutredare:
          • Imad Maatouk, Prof Dr

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: kontrollera
Experimentell: intervention
Övrig: PRISMA-interventions
A multicomponent intervention including social prescriptions, web-based micro-learning modules, and stepwise care based on symptom monitoring.
Andra namn:
  • Social prescription
  • Micro-learning
  • Monitoring (stepwise care)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Functioning, 17 items (EORTC QLQ-F17)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cancer Behavior Inventory Brief Version (CBI-B-D-12)
Tidsram: 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
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Regensburg

Samarbetspartners

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

21 april 2026

Primärt slutförande (Beräknad)

30 november 2028

Avslutad studie (Beräknad)

30 november 2028

Studieregistreringsdatum

Först inskickad

19 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

24 augusti 2026

Första postat (Faktisk)

26 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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