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

NCT07788729 | Recruiting DMC

• 1 other identifier: Z-2026-2552-5
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Cancer; Lung Cancer; Colorectal Cancer; Hematological Cancer; Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (3)

• Cancer Behavior Inventory Brief Version (CBI-B-D-12)

  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

  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)

  From enrollment to the use of treatment at 4 weeks and 3, 6 and 12 months

Study Arms (2)

intervention

EXPERIMENTAL

Other: PRISMA-interventions

control

NO INTERVENTION

Interventions

PRISMA-interventions OTHER

A multicomponent intervention including social prescriptions, web-based micro-learning modules, and stepwise care based on symptom monitoring.

Also known as: Social prescription, Micro-learning, Monitoring (stepwise care)

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Regensburg: lead
• Universitätsklinikum Köln: collaborator
• University Hospital Erlangen: collaborator
• Wuerzburg University Hospital: collaborator
• University Hospital Augsburg: collaborator
• University Hospital Regensburg: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (8)

University Hospital Augsburg

Augsburg, Bavaria, Germany

NOT YET RECRUITING

University Hospital Erlangen

Erlangen, Bavaria, Germany

NOT YET RECRUITING

University Hospital Regensburg

Regensburg, Bavaria, 93053, Germany

RECRUITING

University Regensburg

Regensburg, Bavaria, 93053, Germany

ACTIVE NOT RECRUITING

University Hospital Würzburg

Würzburg, Bavaria, Germany

NOT YET RECRUITING

Faculty of Law, Business & Economics, Inst. for Healthcare Management & Health Sciences

Bayreuth, Germany

ACTIVE NOT RECRUITING

Charité - University Medicine Berlin

Berlin, Germany

NOT YET RECRUITING

University Hospital Köln

Cologne, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasms; Lung Neoplasms; Colorectal Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Anne Herrmann, Prof. Dr.

CONTACT

+49 941 944 5220; Anne.Herrmann@ur.de

Hansjoerg Baurecht, Dr.

CONTACT

Hansjoerg.Baurecht@ur.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 26, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8)