Social Prescriptions and Micro-Learning to Improve Care for Cancer Patients and Their Support Persons
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Regensburg
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
provide informed consent
independently complete interviews and/or questionnaires due to impaired speech, vigilance, or comprehension.
Trial design
Design model
Parallel
Treatments tested in this trial
PRISMA-interventions
Other interventionA multicomponent intervention including social prescriptions, web-based micro-learning modules, and stepwise care based on symptom monitoring.
Treatment groups
384 Participants
are divided into 2 treatment groupsGroup A: interventionExperimental treatment 1 intervention
Group B: controlNo intervention 0 interventions
Trial outcomes
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.
Time frame
From enrollment to the use of treatment at 4 weeks, 3 months, 6 months and 12 monthsSecondary outcomes
1
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 months2
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 months3
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Regensburg
Lead sponsor
Universitätsklinikum Köln
Collaborator
University Hospital Erlangen
Collaborator
Wuerzburg University Hospital
Collaborator
University Hospital Augsburg
Collaborator
University Hospital Regensburg
Collaborator
Charite University, Berlin, Germany
Collaborator
Source ClinicalTrials.gov