Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

INTERVENTIONAL PLATFORM STUDY INVESTIGATING THE IMPACT OF DIGITAL HEALTH SOLUTIONS ON HEALTH OUTCOMES AND HEALTH-CARE RESOURCE UTILIZATION IN PARTICIPANTS RECEIVING SYSTEMIC TREATMENT IN CLINICAL PRACTICE (ORIGAMA)

This study, called ORIGAMA, is investigating how digital health tools can help people with specific types of lung and liver cancer. Researchers want to see if using these tools improves how patients feel and whether it helps them receive more of their treatment at home. This could mean fewer hospital visits and better management of side effects. The study focuses on different stages and types of lung cancer, including non-small cell lung cancer (both advanced and early-stage) and small-cell lung cancer, as well as advanced liver cancer. Participants will be taking a study medicine called RO5541267, and the researchers will carefully monitor their symptoms, side effects, and overall quality of life to understand the benefits of these digital solutions.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

20 Feb 2024

per the UICC/AJCC staging system 8th edition) non-small cell lung carcinoma (NSCLC)

What is this study about?

This study, known as ORIGAMA, is designed to understand how new digital health tools can improve the care and well-being of people living with certain types of cancer. Specifically, it's focusing on individuals with advanced non-small cell lung cancer, extensive small-cell lung cancer, or advanced liver cancer. It also includes people who have had early-stage non-small cell lung cancer removed by surgery. The main idea is to see if combining a study medication (RO5541267) with digital health support can lead to better health results compared to standard care.

The researchers are particularly interested in two key areas. First, they want to know if using these digital tools helps reduce the impact of cancer symptoms on daily life. They will ask participants to report on their symptoms over time. Second, they're looking at whether the digital tools make it easier for patients to receive more of their treatment at home. This could mean less time spent at the hospital or clinic, which can be a big benefit for patients.

Beyond these main points, the study will also keep a close eye on other important aspects of patient health. This includes tracking hospital admissions, emergency visits, and understanding any side effects from the treatment. They will also measure changes in overall quality of life and general well-being. By gathering all this information, the ORIGAMA study aims to figure out if these digital health solutions can genuinely improve how people manage their cancer and live their lives.

Key takeaways

Tests new digital health tools for cancer patients.
Focuses on certain types of lung and liver cancer.
Aims to improve symptoms and enable more home treatment.
Involves a study medicine (RO5541267).
Monitors hospital visits and overall quality of life.
Open to adults aged 18 and over.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

One of the main requirements is that you must have a specific type of cancer. For some participants, this means having advanced non-small cell lung cancer, extensive small-cell lung cancer, or advanced liver cancer that hasn't responded to other treatments or can't be removed by surgery. For other participants, it means you have had early-stage non-small cell lung cancer that has been surgically removed.

The research team will carefully check your medical history and current health to make sure that the study is safe and suitable for you. They will explain all the specific criteria in detail.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced non-small cell lung cancer, extensive small-cell lung cancer, or advanced liver cancer?
OR, have you had early-stage non-small cell lung cancer surgically removed?
Are you able to use digital health tools (like a smartphone app)?
Are you currently receiving treatment for your cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given a study medicine called RO5541267. You will also be using digital health tools, which might include apps or devices, designed to help manage your health. The study combines two stages (Phase II and Phase III), meaning it will carefully test the medication and digital tools over a period of time.

Throughout the study, you will have regular check-ups where the healthcare team will monitor your symptoms and how you are feeling. This will involve answering questionnaires about your symptoms and your overall quality of life. The team will also keep track of any side effects you might experience and whether you need to visit the hospital or emergency room. They will also see if the digital tools help you manage your treatment at home.

The total duration of your participation will depend on the study design and your individual response to treatment. You will receive detailed information about the schedule of visits, tests, and follow-up appointments.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as receiving a new study medicine (RO5541267) and extra support through digital health tools to help manage your symptoms and potentially reduce hospital visits. However, like all medical treatments, there are potential risks, including side effects from the medication. The research team will closely monitor you for any side effects, which will be carefully recorded and managed. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Austria
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Unverified
Spain
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Unverified
Germany

Common questions

What is a 'digital health solution' in this study?

These are tools like smartphone apps or wearable devices that help you track your symptoms, manage your medication, or communicate with your care team from home.

What kind of cancers are included in this study?

The study is for people with certain types of lung cancer (advanced non-small cell, extensive small-cell, or resected early-stage non-small cell) and advanced liver cancer.

What does 'at-home treatment adoption' mean?

It means the study is looking at how well the digital tools help people receive more of their treatment or manage their care from the comfort of their own home.

Will I have to stay in the hospital for this study?

The study aims to see if digital tools can help reduce hospital stays and emergency visits by supporting you at home, but hospital visits may still be necessary depending on your health needs.

Can I leave the study if I change my mind?

Yes, you are always free to withdraw from the study at any point without it affecting your future medical care.