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NCT Number: NCT07788729

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Augsburg, Augsburg, Bavaria, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRISMA-interventions

Other

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Herrmann, Prof. Dr.

CONTACT

[email protected]

+49 941 944 5220

Hansjoerg Baurecht, Dr.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PRISMA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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