CancerPRISMANCT07788729
Social Prescriptions and Micro-Learning to Improve Care for Cancer Patients and Their Support Persons
A study testing PRISMA-interventions in people with Cancer and Lung Cancer, run by University of Regensburg at 8 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Lung Cancer, Colorectal Cancer
- What is being tested?
- PRISMA-interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 8 sitesGermany
- Study dates
- 21 Apr 2026to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- Inability to
- provide informed consent
- independently complete interviews and/or questionnaires due to impaired speech, vigilance, or comprehension.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hansjoerg Baurecht, Dr. contact
8 sites in 1 country
Germany8 sites, 6 recruiting
- Not yet recruiting
University Hospital Augsburg
Augsburg, Bavaria
Nina Ditsch, Prof Dr, +49 821 400-01, nina.ditsch@uk-augsburg.de
- Active, not recruiting
Faculty of Law, Business & Economics, Inst. for Healthcare Management & Health Sciences
Bayreuth
- Not yet recruiting
Charité - University Medicine Berlin
Berlin
Ulrich Keller, Prof Dr, +49 30 450 513 382, ulrich.keller@charite.de
Susanne Rittig, Dr
- Not yet recruiting
University Hospital Köln
Cologne
Freerk Baumann, Prof Dr, freerk.baumann@uk-koeln.de
- Not yet recruiting
University Hospital Erlangen
Erlangen, Bavaria
Andreas Mackensen, Prof Dr, +49 913185-35954, med5-direktion@uk-erlangen.de
- Recruiting
University Hospital Regensburg
Regensburg, Bavaria, 93053
Wolfgang Herr, Prof Dr, +49 941 944-5501, wolfgang.herr@ukr.de
Tobias Pukrop, Prof Dr
- Active, not recruiting
University Regensburg
Regensburg, Bavaria, 93053
- Not yet recruiting
University Hospital Würzburg
Würzburg, Bavaria
Hermann Einsele, Prof Dr, +49 931 201-40001, einsele_h@ukw.de
Imad Maatouk, Prof Dr
About this study
Official title: 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.
- Conditions
- Cancer, Lung Cancer, Colorectal Cancer, Hematological Cancer, Malignant Melanoma
- Being tested
- PRISMA-interventions
- Medical subject headings
- Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRISMA-interventionsOther
Also called Social prescription, Micro-learning, Monitoring (stepwise care)
A multicomponent intervention including social prescriptions, web-based micro-learning modules, and stepwise care based on symptom monitoring.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Not described Receives: Other: PRISMA-interventions |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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).
Measured: From enrollment to the use of treatment at 4 weeks and 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start21 Apr 2026
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Köln, University Hospital Erlangen, Wuerzburg University Hospital, University Hospital Augsburg, University Hospital Regensburg, Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Anne Herrmann, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788729
- Sponsor's protocol ID
- Z-2026-2552-5
- Other IDs
- Z-2026-2552-5
- Acronym
- PRISMA
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRISMA - A Pilot Randomized Phase II Trial on Social Prescriptions and Micro- Learning to Improve Care for Cancer Patients and Their Support Persons
- ClinicalTrials.gov ID
- NCT07788729
- Acronym / sponsor ID
- PRISMA / Z-2026-2552-5
- Conditions
- Cancer, Lung Cancer, Colorectal Cancer, Hematological Cancer, Malignant Melanoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Collaborators
- Universitätsklinikum Köln, University Hospital Erlangen, Wuerzburg University Hospital, University Hospital Augsburg, University Hospital Regensburg, Charite University, Berlin, Germany
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: PRISMA-interventions |
| control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (3 listed)
- Inability to
- provide informed consent
- independently complete interviews and/or questionnaires due to impaired speech, vigilance, or comprehension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRISMA-interventionsAlso: Social prescription, Micro-learning, Monitoring (stepwise care)A multicomponent intervention including social prescriptions, web-based micro-learning modules, and stepwise care based on symptom monitoring. | Other | intervention |
Primary outcome
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.
3 secondary outcomes
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-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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hansjoerg Baurecht, Dr. contact
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRISMA-interventions in people with Cancer and Lung Cancer, run by University of Regensburg at 8 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Herrmann, Prof. Dr. (+49 941 944 5220, Anne.Herrmann@ur.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.