An interventional study of PRISMA-interventions in Cancer, Lung Cancer and Colorectal Cancer, sponsored by University of Regensburg. Recruiting at 8 sites in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by University of Regensburg · Not applicable, Interventional, and Supportive care
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 384 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University of Regensburg is the lead sponsor of 71 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for patients:
Inclusion criteria for Support Persons:
Exclusion Criteria:
Inability to
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: PRISMA-interventions
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)
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.
Time frame: From enrollment to the use of treatment at 4 weeks, 3 months, 6 months and 12 months
Cancer Behavior Inventory Brief Version (CBI-B-D-12)
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.
Time frame: 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
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.
Time frame: 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)
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).
Time frame: From enrollment to the use of treatment at 4 weeks and 3, 6 and 12 months
Not enrolling at this site.
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Nov 2028, 31 months after the start.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 31 months is close to that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
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University of Regensburg