Overview
- The PRISMA Study enrolls cancer patients along with a primary support person. A primary support person can be, for example, a family member or another person who supports the patient.
- Patients are eligible to participate if they have lung cancer, colorectal cancer, cancer of the blood or lymphatic system (such as leukemia or lymphoma), or malignant melanoma. The disease may be in an early or advanced stage.
- The PRISMA study is investigating whether additional resources (short educational videos and the prescription of supportive services) can improve care and quality of life for cancer patients and their caregivers.
Study status: The study is currently enrolling patients (recruitment open).
A cancer diagnosis can turn the patient’s life and the lives of their loved ones upside down.
For the affected patients, facing such a diagnosis is both physically and emotionally challenging. Patients often report anxiety, uncertainty, exhaustion, and feelings of loneliness.
Close caregivers (such as family members or friends) also go through a difficult time. They often take on supportive roles and provide emotional support to those affected.
In this situation in particular, certain support services can be helpful. This includes, for example, support with daily life, counseling on emotional and social issues, special exercise programs for people with cancer, and nutrition counseling.
However, such services are not always easy to find. This is especially true for people living in rural areas. In addition, these support services often focus primarily on patients and rarely include their caregivers.
Studies show that the majority of people with cancer want care that meets their needs. Experts refer to this as “patient-centered care.”
However, studies have also shown that patients do not always receive the care they need.
Many patients report that they don’t learn enough about their illness and treatment or don’t know where to find the appropriate support services for their individual situation. The information provided is also often incomplete or difficult to understand. As a result, many patients feel overwhelmed and uncertain.
In the PRISMA study, researchers are therefore investigating how patients and their caregivers can be supported.
To do this, they are using three different approaches:
Microlearning:
Short explanatory videos are designed to make important information easy to understand. They typically last 5–6 minutes and explain a total of 6 different topics step by step. Participants in the intervention group receive access to these videos during their first appointment with the study team.
This allows patients and their caregivers to watch the content at their own pace and review it as needed.
The videos provide important information and practical tips about the disease, daily life with cancer, and how to cope with it.
Social Prescriptions:
A social prescription is a written recommendation for a support service to help with daily life. It does not involve medication or other cancer treatments. Instead, it focuses on support services that can help outside the scope of medical treatment.
The study team selects programs that are tailored to the individual circumstances and needs of the participants in the treatment group. For example, social prescriptions may aim to provide psychosocial counseling, help patients become more physically active, or adopt a healthier diet. If a patient is exhibiting difficulties in these, or other relevant areas, the patient will be referred to a patient navigator. Together with the patient navigator, cancer patients develop strategies, for example, to overcome loneliness. Furthermore, the patient navigator can help with organizational aspects, such as recommending exercise programs for cancer patients or helping to arrange nutritional counseling consultations.
An additional part of this approach is to support caregivers by providing them with clear, accessible information tailored to the patient's specific support needs.
Digital Tracking of Well-Being:
Using an app, the study team regularly surveys participants’ health status and well-being. This allows the study team to identify early on how participants are doing and subsequently to tailor support to their current needs and the severity of their impairments. Patient support specialists contact participants regularly by phone and provide targeted additional support.
You can read more about the specific goals the researchers are pursuing with these two offerings in the section “What is the goal of the PRISMA study?”.
People with various types of cancer can participate in the PRISMA study. These include:
- Colorectal cancer
- Malignant melanoma
- Diseases of the blood or lymphatic system (for example, leukemia or lymphoma)
- Lung cancer
Patients must present with early or advanced stages disease.
In addition, the study includes one support person (e.g., a family member or friend) for each participating cancer patient.
You can read more about this under “Who is the study suitable for?”.
The English title of the PRISMA study is:
“A pilot randomized phase II trial on social prescriptions and micro-learning to improve care for cancer patients and their support persons.”
In other words:
The PRISMA study investigates whether
- social prescriptions, micro-learning (in the form of short explanatory videos), and digital tracking of well-being can improve care for cancer patients.
- In this process, cancer patients and their caregivers are examined.
Objectives of the PRISMA Study
The researchers aim to determine how effectively the study’s support services can improve the quality of life for cancer patients and their caregivers.
They also want to find out if the benefits are worth the costs. This will help decide whether health insurance companies cover the costs for these services in the future.
In addition, the researchers are examining whether the services offered by the PRISMA study can influence the following among participants:
- the feeling of being able to take action and make a difference for their own health.
- knowledge about their own illness as well as about diagnostic and treatment options.
- the use of healthcare services, such as doctor visits, screenings, or therapies.
Lastly, the researchers are evaluating the real-world integration of the study´s interventions into the participants daily lives.
If patients and their caregivers wish to participate in the PRISMA study, they must:
- be at least 18 years old.
- speak German well enough to understand and answer the questions in the questionnaires and interviews.
- sign a consent form.
In addition, patients must meet the following additional requirements:
- The patient has a confirmed diagnosis of lung cancer, colorectal cancer, a cancer of the blood or lymphatic system (such as leukemia or lymphoma), or malignant melanoma. The diagnosis was received within the last 12 months.
- The cancer is in an early or advanced stage.
- The patient must designate a primary support person
- Doctors estimate the patient’s life expectancy to be at least 18 months.
- The participant is being treated in the oncology department of a hospital participating in the study.
- The participant is able to manage daily activities largely on their own. Doctors rate the patient’s performance status according to the ECOG status criteria as 2 or less.
If any of the following apply, participation in the PRISMA study is not possible:
- The person is unable to give informed consent to participate in the study.
- The person cannot independently complete questionnaires or answer interview questions, for example, because their ability to speak, understand, or focus is limited.
The PRISMA study is a:
- Randomized study: In a randomized study, participants are randomly assigned to either the treatment group or the control group.
- Multicenter study: Patients can participate at various study centers in Germany.
- Open-label study: In an open-label study, both the participants and the study team know whether a person is in the treatment group or the control group.
(1) Selection of Participants
The study team or the treating doctors will talk to suitable patients about the PRISMA study.
They will then verify whether the cancer patient meet the eligibility criteria for participation in the PRISMA study.
Each patient selects a primary support person. This could be a family member or a friend for example. This person supports the patient in their daily life as they face the challenges of cancer and provides emotional support. If the support person also meets the eligibility criteria for participation, the pair may participate in the PRISMA study.
(2) Initial Consultation and Informed Consent
During an informational session at the study center, a member of the study team will inform the patient and the support person regarding the PRISMA study and answer any questions that arise.
If the patient is eligible for the study and wishes to participate, she or he must sign a consent form. The caregiver must also sign a consent form.
(3) Randomization
Participants (i.e., pairs consisting of a person with cancer and their caregiver) are randomly assigned to either the treatment group or the control group.
(4) Examination at the Study Center
Afterward, all participants (cancer patients and caregivers from both the treatment and control groups) complete the initial questionnaires. This can be done either online or on paper.
The questionnaires cover topics such as:
- quality of life
- confidence in one’s own ability to cope with health challenges
- use of health information
In addition, questions will be asked about the following and other topics, such as:
- Knowledge about health, illness, and care.
- Use of healthcare services (such as doctor visits or therapies).
- Personal characteristics such as age, gender, or education.
Based on the responses, individually tailored social prescriptions are prepared for the participants in the treatment group.
After completing the questionnaires, participants will be informed whether they have been assigned to the treatment group or the control group.
Regular appointments:
Additional surveys will be conducted throughout the PRISMA study. Participants will primarily complete the same questionnaires as they did at the first appointment. This helps researchers monitor the impact of the support services over time.
Participants will be interviewed 4 weeks, 3 months, 6 months, and 12 months after the start of the study.
(5) Start of Additional Support for the Treatment Group:
Participants assigned to the treatment group will receive
- social prescriptions tailored to their individual needs
- information about the educational videos and how to access them
- access to an app for digitally tracking their well-being
Use of the educational videos will be documented during the study phase. Among other things, the frequency and duration of the patients’ video viewings will be recorded. This is done using integrated software.
During the first appointment with participants in the treatment group, the study team schedules the next appointment for 4 weeks later.
At this appointment, the study team will assist with installing the accompanying study app and explain how it works.
Every 2 weeks, the app asks questions about:
- Exhaustion / Fatigue
- Loneliness
- Anxiety
- Problems with social welfare
- Social relationships
- Coping with daily life
Additional Interviews:
Cancer patients in the treatment group who have agreed to an interview will be invited to a personal conversation.
During this interview, they can share their experiences with the PRISMA study with a member of the study team. Caregivers are also invited to the interviews.
The interviews take place 3, 6, or 12 months after the start of the study and can be conducted in person, by phone, or by video call. Participation in the interviews is voluntary.
To help the researchers better analyze the responses, the conversation will be recorded. Participants must sign a consent form beforehand.
(6) End of the Study:
The PRISMA study will monitor participants for 12 months. At a final appointment, all participants will complete the questionnaires again (either online or on paper). The final appointment does not need to be held at the study center.
These are the potential benefits of participating in the PRISMA study:
- Participants assigned to the treatment group will receive additional support services. These services could help patients and their caregivers cope better with the disease.
- The researchers believe that participants will become more confident in their abilities and make better use of health services such as doctor’s appointments, special exercise programs for people with cancer, or nutrition counseling.
- The study is evaluating additional information and support services, not new medical treatments. Therefore, the researchers do not expect any side effects from participating in the study.
However, participating in the PRISMA study may also have disadvantages:
- Participants in the control group cannot benefit from the potential advantages of the support services offered within the PRISMA study.
- Some questions may be emotionally taxing or cause participants to dwell on uncomfortable topics. For example, when the questions concern the participants‘ worries or fears
Important to know: Individual questions can be skipped at any time.
Where is the study being conducted?
The PRISMA study is taking place at various study sites. These include:
- Regensburg University Hospital, Department of Internal Medicine III
- University Hospital of Würzburg, Department of Internal Medicine II
- Erlangen University Hospital, Department of Internal Medicine V
- Augsburg University Hospital, Department of Internal Medicine II and Comprehensive Cancer Center Augsburg
- University Hospital of Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen, Bonn, Cologne, Düsseldorf
- Charité Berlin, Department of Hematology, Oncology, and Cancer Immunology
- Freiburg University Hospital, Comprehensive Cancer Center
Who is funding the study? Will participants incur any costs?
Participation in the study is free of charge for patients. However, you will not receive any compensation for your time or expenses. Travel expenses are not reimbursed as part of the study. Whenever possible, clinic visits required for the study will be scheduled in conjunction with your treatment appointments so that you do not have to make a separate trip to the clinic for the study.
If you have any questions about the study’s funding, you can ask the study team, for example during the informational meeting.
How many participants will the study accept? Are there still places available?
The PRISMA study is enrolling a total of 384 pairs (i.e., patients and caregivers).
Those interested can find out where spots are still available by contacting the respective study centers.
Contact persons at the study centers
Contact person for the Augsburg study center:
Augsburg University Hospital
Julia Eicher
E-mail: Julia.Eicher-at-uk-augsburg.de
Phone: 0821400-168 365
Contact person for the Berlin Study Center:
Charité – Berlin University Medical Center
Sarah Felgner
E-mail: sarah.felgner-at-charite.de
Phone: 030450513470
Contact person for the Erlangen Study Center:
University Hospital Erlangen
Luisa Arold
E-mail: luisa.arold-at-uk-erlangen.de
Contact person for the Cologne Study Center:
University Hospital Cologne
Adriane Styra
E-mail: adriane.styra-at-uk-koeln.de
Phone: 0221 47815747
Contact person for the Regensburg Study Center:
Regensburg University Hospital
Christoph Neuhäuser
E-mail: Christoph.neuhaeuser-at-ukr.de
Phone: 0941 944-18218
Contact person for the Würzburg Study Center:
University Hospital Würzburg
Julia Petzoldt-Weigel
E-mail: Petzoldt_J-at-ukw.de / NCT_PRISMA-at-ukw.de
Phone: 0931 201 40959
Contact person for the Freiburg Study Center:
Freiburg University Hospital
Cahide Aram
E-mail: cahide.aram-at-uniklinik-freiburg.de / med1.kontakt.studienzentrale-at-list.uniklinik-freiburg.de
Phone: 0761 270 32909
- Information for more confidence and involvement – National Decade Against Cancer (German)
- PRISMA Study for Better Cancer Care (German)
- University of Regensburg on the PRISMA Study (German)
The PRISMA study was supported by a member of the Patient and Family Advisory Council.
Scientific Publications (Selection)
Tariman, J. D., Berry, D. L., Cochrane, B., Doorenbos, A., & Schepp, K. (2010). Preferred and actual participation roles during health care decision making in persons with cancer: a systematic review. Annals of oncology : official journal of the European Society for Medical Oncology, 21(6), 1145–1151. https://doi.org/10.1093/annonc/mdp534
Napierala, H., Krüger, K., Kuschick, D., Heintze, C., Herrmann, W. J., & Holzinger, F. (2022). Social Prescribing: Systematic Review of the Effectiveness of Psychosocial Community Referral Interventions in Primary Care. International journal of integrated care, 22(3), 11. https://doi.org/10.5334/ijic.6472
Basch, E., Schrag, D., Henson, S., Jansen, J., Ginos, B., Stover, A. M., Carr, P., Spears, P. A., Jonsson, M., Deal, et. al. (2022). Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial. JAMA, 327(24), 2413–2422. https://doi.org/10.1001/jama.2022.9265
Sanson-Fisher R, Forshaw K, Waller A, Mackenzie L, Bryant J, Herrmann A: Assessing patients’ experiences of cancer care across the treatment pathway: A mapping review. Supportive Care in Cancer 2019. 27(6): 1997-2006. https://doi.org/10.1007/s00520-019-04740-1
This study description was prepared by authors from the Cancer Information Service, under the direction of Dr. S. Weg-Remers, based on the study documentation.