Cancer, Colorectal Cancer, Hematological Cancer, Lung Cancer, Malignant Melanoma
Conditions
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.
Interventions
OTHERPRISMA-interventions
A multicomponent intervention including social prescriptions, web-based micro-learning modules, and stepwise care based on symptom monitoring.
Sponsors
University Hospital Regensburg
Charite University, Berlin, Germany
University of Regensburg
Universitätsklinikum Köln
University Hospital Erlangen
Wuerzburg University Hospital
University Hospital Augsburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Functioning, 17 items (EORTC QLQ-F17) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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-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. |
| 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 | 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). |
Countries
Germany
Contacts
CONTACTAnne Herrmann, Prof. Dr.
CONTACTHansjoerg Baurecht, Dr.
Outcome results
None listed