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

August 24, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

384

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Bayreuth, Germany
        • Active, not recruiting
        • Faculty of Law, Business & Economics, Inst. for Healthcare Management & Health Sciences
      • Berlin, Germany
        • Not yet recruiting
        • Charité - University Medicine Berlin
        • Contact:
        • Principal Investigator:
          • Susanne Rittig, Dr
      • Cologne, Germany
    • Bavaria
      • Augsburg, Bavaria, Germany
        • Not yet recruiting
        • University Hospital Augsburg
        • Contact:
      • Erlangen, Bavaria, Germany
        • Not yet recruiting
        • University Hospital Erlangen
        • Contact:
      • Regensburg, Bavaria, Germany, 93053
        • Recruiting
        • University Hospital Regensburg
        • Contact:
        • Principal Investigator:
          • Tobias Pukrop, Prof Dr
        • Principal Investigator:
          • Daniel Heudobler, Prof Dr
        • Sub-Investigator:
          • Daniel Wolff, Prof Dr
        • Sub-Investigator:
          • Kathrin Reuthner
        • Sub-Investigator:
          • Michael Koller, Prof Dr
        • Sub-Investigator:
          • Florian Zeman
      • Regensburg, Bavaria, Germany, 93053
        • Active, not recruiting
        • University Regensburg
      • Würzburg, Bavaria, Germany
        • Not yet recruiting
        • University Hospital Würzburg
        • Contact:
          • Hermann Einsele, Prof Dr
          • Phone Number: +49 931 201-40001
          • Email: einsele_h@ukw.de
        • Principal Investigator:
          • Imad Maatouk, Prof Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Experimental: intervention
Other: PRISMA-interventions
A multicomponent intervention including social prescriptions, web-based micro-learning modules, and stepwise care based on symptom monitoring.
Other Names:
  • Social prescription
  • Micro-learning
  • Monitoring (stepwise care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Functioning, 17 items (EORTC QLQ-F17)
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer Behavior Inventory Brief Version (CBI-B-D-12)
Time Frame: 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
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Regensburg

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2026

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2028

Study Registration Dates

First Submitted

August 19, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 26, 2026

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z-2026-2552-5 (Other Grant/Funding Number: Nationales Centrum für Tumorerkrankungen (NCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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