engagement

The Importance of Patient Engagement and its Role in Clinical Trials

Learn more about the role patient participation plays in clinical research, and how you can make a difference in trial design, recruitment, and overall patient experience.  

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About the Center for Information and Study on Clinical Research Participation, Inc. (CISCRP) 
CISCRP’s core mission is to provide accessible, relevant, useful, high-quality educational resources, programs, and services that increase awareness and understanding of the clinical research process; recognize and appreciate the unprecedented gift of participation in clinical trials; enhance and enrich the participation experience for patients and their families; and promote engagement and partnership between clinical research professionals, patients, and the public. 

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14 Ways to Support Your Mental Health During a Clinical Trial
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14 Ways to Support Your Mental Health During a Clinical Trial

By: Meredith Boley, Bezyl For people struggling with their mental health, support can be life changing. The same is true for people who participate in clinical trials!  The clinical trial environment, which can sometimes lack adequate psychological support and resources, often creates or compounds mental health struggles. As a result, both patients and caregivers may feel isolated, overwhelmed, and unsupported.  Unpacking the Patient Experience  Clinical research participants can experience heightened levels of stress, anxiety, uncertainty, and even depression. This is primarily due to the unfamiliarity of the trial process, potential side effects of treatments, concerns about their health outcomes, and because they are often managing a significant illness or condition while navigating trial complexities that their social circle may not fully understand.   Caregivers Face Mental Health Challenges, Too  Caregivers of clinical research participants can also face unique mental health challenges. They may experience high levels of stress and anxiety due to the demands of caregiving, concerns about their loved one’s health, and the emotional burden of supporting someone through a clinical trial. Caregivers may also experience feelings of isolation, fatigue, and burnout, especially if they lack a support network or resources to help them manage their caregiving responsibilities.  Why It Matters  Patient and caregiver mental health during clinical trials is important because it directly impacts both groups’ overall well-being, which can affect a patient’s ability to stick to the trial protocol and to manage treatment-related side effects. When mental health is compromised, patients may experience reduced motivation, increased fatigue, and a decline in physical health, impacting trial outcomes and data reliability.   Furthermore, strong mental health support can enhance retention rates, reduce dropout rates, and help ensure the trial’s success. By addressing mental health proactively, both patients and caregivers are better equipped to handle the emotional and psychological demands of participating in a clinical trial, leading to more accurate and reliable study results – which ultimately deliver better treatment options to the people who need them.  14 Clinical Trial Mental Health Tips  With this in mind, here are 14 ways that patients and caregivers can give their mental health a boost while navigating clinical research participation.  Establish a Routine: Maintaining a consistent daily routine can provide a sense of normalcy and stability, which can help reduce anxiety and stress. This includes regular sleep, exercise, mealtimes, and scheduled relaxation or leisure activities.  Stay Informed: Understanding the clinical trial process, potential side effects, and expectations can help reduce fear and anxiety. Patients should feel empowered to ask questions and seek clarification from their healthcare providers. Knowledge about the trial can help patients feel more in control of their situation.  Access Professional Mental Health Support: Engaging with a therapist, counselor, or psychologist who specializes in working with clinical trial participants can provide tailored emotional support and coping strategies. Professional support is invaluable for managing anxiety, depression, or other mental health concerns that may arise.  Practice Self-Care: Self-care activities, such as reading, journaling, meditating, or engaging in hobbies, can help manage stress and improve overall well-being. Taking time for oneself is crucial for maintaining mental and emotional balance during the demands of a clinical trial.  Physical Activity and Exercise: Regular physical activity is proven to boost mood, reduce stress, and improve overall mental health. Even light exercise, such as walking, yoga, or stretching, can help alleviate anxiety and depression symptoms and improve physical health, which can be particularly beneficial during clinical trials.  Nutrition and Hydration: Eating a balanced diet and staying hydrated can significantly impact mood and energy levels. Good nutrition supports brain health and overall well-being, which is important for maintaining a positive outlook and physical health during a clinical trial.  Build a Support Network: Build a support network that includes healthcare providers, fellow trial participants, friends, family members, and community groups. This network can offer emotional support, practical advice, and a sense of solidarity.  Set Realistic Goals and Expectations: Setting achievable personal goals can provide a sense of purpose and accomplishment. It’s also important for patients to set realistic expectations about what they can handle and to recognize their limits to avoid burnout or frustration.  Practice Mindfulness and Relaxation Techniques: Techniques such as deep breathing, meditation, progressive muscle relaxation, and visualization can help reduce stress and anxiety, improve focus, and promote a sense of calm. These practices can be especially helpful for managing the emotional ups and downs that come with clinical trials.  Keep a Journal: Writing down thoughts, feelings, and experiences can be therapeutic and help patients process their emotions. Journaling can also be a useful tool for tracking emotional states as well as identifying patterns and triggers of anxiety or stress.  Engage in Positive Social Activities: Participating in social activities or connecting with friends and family can help reduce feelings of isolation and provide emotional support. Engaging in positive, supportive social interactions can improve mood and provide a sense of normalcy.   Stay Connected with the Research Team: Maintaining open communication with the clinical trial research team can help address concerns or issues as they arise. Feeling supported and heard by the research team can alleviate stress and improve the overall trial experience.  Create a Calming Environment: Having a designated, comfortable space for relaxation or mindfulness practice can help manage stress and provide a refuge during difficult times. This environment can include calming elements like soft lighting, soothing music, or aromatherapy.  Connect with Support Communities: Connecting with others in similar situations can help reduce feelings of isolation and provide valuable peer support.   Find Mental Health Support Tools That Work for YOU  Creating a supportive environment on your own can be challenging, even with the above tips. That’s where support tools come in! Bezyl is an app that offers a personalized platform for mental health tools. Designed to support clinical trial participants and caregivers – as well as other people who’ve experienced trauma – the app includes features like:   Mental well-being is crucial for navigating the challenges of a clinical trial, maintaining resilience, and improving overall outcomes. Don’t hesitate to seek support, whether through Bezyl, healthcare providers, or your personal network.  More About Bezyl: Clinical Trials For All partner Bezyl was founded with a mission to revolutionize mental health support by leveraging the power of connection and community. Our vision is to create a world where mental health support is accessible, personalized, and integrated into everyday life. Our app, available on Google Play and the Apple Store, offers a comprehensive suite of tools designed to support mental well-being. From connecting with family and friends through our Spheres of Support feature to tracking moods and accessing a library of resources, Bezyl is here to help you every step of the way. Visit Bezyl.com. 

Give the Gift of Health Through Clinical Trial Participation 
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Give the Gift of Health Through Clinical Trial Participation 

How do you give back? Whether you volunteer your time, donate to causes you believe in, or help your community in other ways, doing your part feels good. As you think of ways to make a difference, clinical research may not be the first thing that comes to mind. However, you may be shocked to learn just how much of an impact participating in a trial has.   Clinical Research Changes Lives  Clinical research is the process of making sure new medical discoveries are safe and effective. Participants — everyday people who either have a medical condition or who participate as healthy volunteers — make this process possible.  When you participate in clinical research, you can be a part of:   These positive effects ripple throughout communities. As a clinical trial participant, you can give the gift of health to a wide range of people. A new treatment that you contribute to through clinical research could save or improve the life of a friend or family member; it could also help a stranger across the country or make life better for future generations.   Paying It Forward  Even as clinical trials continue to improve medicine, the sad truth is that many people still can’t get the care that a lot of us may take for granted. Imagine if you could be a part of developing new treatments while also improving vaccine access for children in need. By participating in a clinical trial that partners with Greater Gift, you can do just that.   Greater Gift is a non-profit that spreads awareness of the benefits of clinical research and expresses gratitude for everyone involved in the process. They pay the gift of health forward by giving vaccines to children in developing countries through Gavi, The Vaccine Alliance. Greater Gift also partners with Feeding America to provide meals for children facing hunger. Through the clinical operations giving program, researchers can choose to donate on behalf of participants or other contributors.   Make an Impact on Global Health  If you are a research sponsor, partnering with Greater Gift can extend the impact of your trial. Showing gratitude makes a big difference for clinical trial participants. After all, these volunteers make research possible, and a simple thank you goes a long way in showing them you appreciate their contribution. When you pair this gratitude with a donation that pays their impact forward, it has an even greater effect.   If you are a potential clinical trial participant, you can help Greater Gift by increasing awareness of their mission. You can also donate to boost Greater Gift’s reach in bringing clinical research to more underrepresented communities. This work is only possible with the help of donors and sponsors.   A great place to start getting familiar with research is through our resource library. We’ve collected information from a variety of sources from trial participants to national health organizations and put it in one convenient place. Once you’ve learned more about how clinical research works, spread the word with our shareable assets. These graphics make it easy to amplify awareness among your friends, family, and professional network. It only takes a few minutes, but the effect can be significant.  

Improving Your Access to Clinical Trials — And Why It Matters
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Improving Your Access to Clinical Trials — And Why It Matters

By: Scott Stout, MedVector Think of the biggest medical breakthroughs of the modern era. Anything you can name, from the end of smallpox to the recent development of COVID-19 vaccines, owes its existence to clinical research.   Clinical research uncovers new or improved treatments for both rare and common conditions, and clinical trials confirm their efficacy and safety in humans. Both clinical research and clinical trials are essential for moving medicine forward, saving lives, and increasing quality of life for you, your loved ones, and your community.   By understanding what clinical research is, why it matters, and how to break down barriers to participation, you can become part of this essential process of discovery. And why should you consider it? Participating in a clinical trial can help improve the health of people everywhere, and it’s easier than you may think.   What Is Clinical Research?   Clinical research is a scientific process that examines new treatment options and/or new observations about health and illness in people. Clinical research can also include observational studies. These studies look at medical data and/or biological samples, but do not test new treatments. Then, through clinical trials, researchers confirm potential benefits and identify risks of new drugs and therapies before making them available to the public.   The clinical trial process happens in phases. Every step of the way, researchers must follow strict standards to prove efficacy and patient safety. Once a clinical trial demonstrates a new treatment is safe and effective, patients everywhere can begin to access its benefits.   Why Are Clinical Trials Important? Clinical trials are the backbone of medical progress. They take discoveries from the lab into practice, bringing the latest developments in medicine and technology to communities like yours. Without clinical trials, medicine simply couldn’t evolve, and, more importantly, treatments that save and improve lives wouldn’t be able to reach the people who need them.  How You Benefit From Clinical Trials   The benefits of clinical trials for science as a whole are clear, but what about the benefits for people who participate in these trials?   Clinical trial participants benefit in many ways. You:   Barriers to Clinical Trial Accessibility   If clinical trials are so essential, why have 91% of Americans never participated in one?  Some barriers to trial access and participation include:   But what if the doctors you already know and trust could offer clinical trials as a care option? Even considering the barriers to clinical research, studies suggest 75% of patients would participate in a clinical trial if it were recommended by their doctor. Knowing this, an obvious conclusion to patient-centric participation in clinical research is … our doctors.   However, not all doctors want to get involved in research, and the ones that attempt to do so typically stop. Underenrollment, paperwork, and strict compliance guidelines create additional work, requiring doctors to dedicate a significant portion of their resources to keep running trials, let alone be profitable.   Why Don’t Doctors Just Refer Their Patients to Clinical Trials? In a perfect world, doctors would refer their patients into clinical trials, but even after addressing the awareness problems, several factors prevent this:   Clinical Trials as a Care Option  We know that patients want to hear about clinical trials from their trusted doctors, but current avenues to provide access are not ideal: either become an investigator or refer a patient (customer) to another doctor. So how do we bridge this gap and align the interests of patients, clinical trial sites, and treating physicians?   A decentralized clinical trial (DCT) gives patients access to clinical trials from alternative locations, such as their home or local clinic, but in an industry that values “caution” over “innovation,” the process of putting DCTs into practice has been painfully slow.  At the peak of the COVID-19 pandemic, telemedicine, a decentralization tool in the telehealth family, became common practice and has continued to be widely used. Telehealth is the delivery of health care services or monitoring by video, messaging, or other options that don’t require a physical visit to a doctor’s office. A unique benefit for clinical research is that telehealth enables a patient to be in two places at once: physically at their doctor’s office, while virtually at a clinical trial site. This concept allows patients to access advanced medicines from a variety of locations including, not only treating physician’s offices, but also local labs or pharmacies.  Even more importantly, by enabling treating physicians to “host” clinical trial appointments from their local practice, it reduces the referral concerns of patient leakage, lost revenue, and control of care. Under this model, patients have increased access to research while their doctors become part of the referral, continuing to be the primary caregiver for the patient.  Get Involved in Clinical Research  If you’re a patient interested in moving the needle toward clinical research as a care option, you can start by talking to your doctor. Ask them if they’re familiar with clinical trials and if they’re aware of the new technologies bringing them to local communities like yours. Even if they aren’t currently involved in research, this question could spark your doctor’s natural curiosity and pave the way for future access to new care options, which is good for everyone!   Our website also has a variety of resources for you to explore, including tools to search for trials near you. As clinical research continues to evolve and become more accessible, you can help be part of the future of medicine by getting involved. 

LGBTQIA+ Research Participation: Why It Matters and How You Can Help
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LGBTQIA+ Research Participation: Why It Matters and How You Can Help

Have you ever wondered how new medicines and treatments are developed? The answer is clinical trials. These studies test how well new medical approaches work, and they are an important step in bringing new treatments to people who need them.   For these trials to work best, research participation needs to include all kinds of people: from different racial or ethnic backgrounds, across different regions, and different sexual orientations and gender identities. That’s where you come in. If you’re part of the LGBTQIA+ community, your participation in clinical trials is more important than you might realize. Your experience and your health matter. By participating in clinical trials, you can help shape the future of health care for yourself and your community, now and for generations to come.   Why LGBTQIA+ Trial Participation Matters  Historically, LGBTQIA+ individuals have often been left out of medical research. This means that fewer LGBTQIA+ people have been involved in studies compared to the percentage of people who are part of the community overall.   This lack of representation has a real impact. LGBTQIA+ people often face unique health challenges. For example, studies show higher rates of certain cancers and mental health conditions in some LGBTQIA+ groups. By participating in clinical trials, you can help researchers better understand these differences and develop treatments that work for everyone.  There are also some health concerns that are specific to LGBTQIA+ individuals. For instance, transgender people may have unique needs related to hormone therapy or gender-affirming surgeries. When LGBTQIA+ people are included in research, it helps health care providers offer more informed, compassionate care to all patients, including those with diverse sexual orientations or gender identities.  Challenges and Solutions in LGBTQIA+ Clinical Research Participation  LGBTQIA+ individuals may face some unique challenges when it comes to clinical trials. But for each challenge, researchers, organizations, and communities are working on solutions, as reported by Citeline:   By getting involved in clinical trials, you can also be part of the solution! Your participation helps researchers learn how to make trials more inclusive and accessible. It also sends a message that LGBTQIA+ health deserves attention.  Benefits of Participating in Clinical Trials  We’ve talked about why your participation matters for the LGBTQIA+ community as a whole, but there are also many potential benefits for you as a participant:  Every clinical trial is different, and the benefits can vary. It’s important to discuss the potential benefits and risks with the research team.  How to Get Involved in Clinical Trials  Ready to take part in a trial? Here are some ways to get started:   Remember, you always have the power to choose which studies you want to be part of and to ask for what you need during the process.  You Can Make a Difference  LGBTQIA+ participation in clinical trials is crucial for advancing health care that truly serves everyone. While there may be challenges in participating, there are also organizations and researchers working hard to make clinical trials more accessible and inclusive. By getting involved, you can become part of this positive change.  Whether you decide to participate in a clinical trial, share this information with others, or simply learn more about LGBTQIA+ health research, you’re taking an important step. Every action, no matter how small, contributes to a future where health care truly serves all of us. 

Tips for Searching for Clinical Trials as a Caregiver
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Tips for Searching for Clinical Trials as a Caregiver

If you are a caregiver, you aren’t alone; according to the Caregiver Action Network, over 65 million people in the U.S. (about 29% of the population) provide care for a chronically ill, disabled, or elderly family member or friend. The role caregivers play is different for everyone, whether it involves helping with a few tasks or full-time, live-in care. Across this spectrum, it’s clear that caregiving is essential for our communities and deserves recognition and support.   Caregivers help their loved ones in many ways, but one that may not come to mind at first is finding clinical trials. Enrolling the person you are caring for in a clinical trial can help them find new ways to manage their health, while also benefiting others with the same condition. If you’re interested in learning more about how clinical trials work and your role in finding a trial as a caregiver, the information in this article can help you get started.   What You Should Know About Clinical Trials  Before we explore more details about finding clinical trials as a caregiver, we should first discuss what clinical trials are.  A clinical trial is the process of testing a new treatment option, such as a medication or device. Trials happen in different phases, starting with smaller groups and progressing to larger ones. Throughout every step of the process, researchers follow strict standards to make sure they collect accurate data and keep participants safe. If the trial shows the new treatment is effective, it can be approved to become available to more people.   What does this mean for your loved one? Clinical trials often provide access to treatments that are not available anywhere else, giving them a new option to manage their condition. In addition to the personal benefits, taking part in a trial is also a valuable gift to others with the same condition. It gives hope for new treatment options that wouldn’t be possible without research.   How to Find a Clinical Trial Once you’ve decided that you’re interested in a clinical trial for someone close to you, the next step is exploring trials that could be a good fit. The process can seem overwhelming at first, but the good news is that there are many resources that can guide your journey and support you along the way.   Your loved one’s doctor is a great starting point for discussing clinical trials. Although not all doctors are involved in clinical trials, they will be able to answer some of your questions about the process and how it could fit with any current treatment(s). In some cases, they could recommend a trial that they are involved in or familiar with.   Even if your loved one’s doctor is not involved in trials, there are still many ways to find options. Sites like Carebox, Antidote, and ClinicalTrials.gov are great resources for searching for trials. You can look based on a condition and see key details about the trials within these tools.   From Searching to Finding the Right Fit  During this process, there are many elements to consider when deciding whether a trial is a good fit for the person in your care.   Each trial has different rules for who can participate. This may include how far along the disease is, whether your loved one has or does not have certain symptoms, other conditions, age, and a variety of other factors. Be sure to have their medical history available as you search. If you have any questions about whether a trial could be a good fit, reach out to the contact for that trial. They can talk through requirements with you and give you more details about the kind of participants the trial is looking for.   You should also consider the impact participation may have on you as a caregiver. Is the trial nearby? Will you need to travel to take your care recipient to appointments? Are there options to participate from home? This can help you plan to make sure participating is manageable not only for your loved one, but also for you. Many organizations in the clinical research community are working to improve access. The trial organizers may be able to point you in the direction of resources to help make participation easier, such as patient advocacy networks or support groups for caregivers.  Answers to Your Clinical Trial Questions Throughout the process of finding trials for someone in your care, communication is key. If you have questions, be sure to speak up. Researchers understand the key role participants play, and they should support you in finding the answers you need.   Our Resource Library is also a valuable tool for finding more information about clinical trials. Whether you are actively searching for trials for your loved one or are just starting to look into clinical research, you can make a life-changing impact by learning more and spreading the word.  

Redefining Clinical Trial Accessibility in the Age of DCTs
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Redefining Clinical Trial Accessibility in the Age of DCTs

You want to increase clinical research participation, but access issues keep getting in the way. How can people take part in clinical trials if they don’t know about them, can’t physically reach them, or don’t have the resources to participate remotely?   Uncover solutions to the research accessibility problem in the Clincial Trials For All discussion, “Redefining Clinical Trial Accessibility in the Age of DCTs.” Featuring Lightship patient advocacy and patient experience experts Samantha Eells, Sabina Kineen, Mel Mann, and Allison Rosen and hosted by Alec McChesney, director of business development at SCORR Marketing, this discussion is a must-watch for anyone interested in making research more equitable, diverse, and widespread.   Watch the recording now to explore: