They have been heralded as the invisible army: An “unseen, unpaid, and indispensable” force who support patients going through their treatments – and often playing a crucial role in making that treatment a success. Sometimes patients are too sick, too young, or too elderly to take charge of their own health and care needs. They need a voice, and assistance, which caregivers can provide.
Caregivers also often act as the proxy for many patients in navigating the complex world of clinical trials and need to be considered in the process. So, what do we know about the caregiver’s role and typical experience in trials, and how can we best support them?
"Family caregivers have an immeasurable impact on the lives of those they assist, but their hours are long and their work is hard. Many put their own lives on hold to lift up someone close to them."
Connecting Patients with Trials
One of the more visible roles that caregivers play is in linking up their loved one with a suitable clinical trial. This role is expanding, with many organizations (often founded by patients and caregivers themselves) springing up to help connect potential trial participants with the healthcare professionals running these trials.
Industry is also embracing this expanding role of caregivers, acknowledging the invaluable insight they can provide to improve the trial experience. In a recent article, Kevin Hudziak, Innovation Lead at Eli Lilly, discussed how Lilly “needs to engage more effectively with caregivers and understand their perspectives, as they are critical to supporting the patient on their journey.” They are using storytelling as a tool in providing and sharing content that is relevant to patients and caregivers alike, including sharing caregiver stories.
The caregiver’s role does not stop once they’ve supported their friend or family member in joining a trial. In many cases, their role increases and they are critical to the success of a patient’s participation in a clinical trial, explains John Schall, CEO of the National Family Caregivers Association.
“The caregiver is the closest and most constant observer of the patient. It is important that the caregiver knows what side effects, physical changes, and cognitive changes to watch for. Even if a change does not seem like something to report, it may in fact be critical.”
Indeed, patients have shown improved adherence to dietary restrictions, better adherence to medication, and were more likely to complete a self-management programme after hospital discharge when a caregiver was present. One study also showed that the type of caregiver - whether they are a spouse or other partner, such as an adult child - can actually positively impact the results of trials and the interpretations of those results.
Ensuring that the needs of caregivers are considered, and that they are fully involved and informed about your trial, offers patients the best possible chance of having a positive trial experience and might even improve their outcomes too.
How Best to Support Caregivers?
Given their vital role in supporting patients on trials, what have we learnt about supporting caregivers?
Firstly, it is essential that patient information is not only communicated in a way that meets patient preferences, but that is geared towards caregivers too. Gail Hunt, President and CEO of the National Alliance for Caregiving, says it’s important to “speak not only in patient-centered language, but also caregiver-centered language.” This means, for example, asking the caregiver whether they are able and/or willing to perform certain duties when discussing the protocol.
In this whitepaper, research suggests that it’s not only healthcare professionals (HCPs) that overlook the role of the carer; the healthcare communications sector proactively talks to patients, doctors, nurses, and pharmacists, but rarely to the carer.
At Longboat, we ensure that our clinical trial patient engagement also speaks to caregivers, and that they can get access to all the same trial content as patients. We link patients and caregivers to online resources for support, information around the trial’s design, the condition and the treatment, as well as support around visit attendance planning and preparation. Our goal is to centralize as much information as possible about the patient’s participation in the study to support them in their work.
But, in addition to ensuring that their unique information needs are met, Hunt has some other recommendations to help support caregivers, including providing guidance on how to be an effective observer — what to look out for, how to identify it, and how to respond to it – as well as preparing both caregiver and patient for the emotional aspect of ending treatment, when the clinical trial ends.
- Caregivers have long been the unseen heroes of clinical trials, but are becoming recognized as a crucial stakeholder
- Ensuring that trial information and communications are fit-for-purpose for caregivers as well as patients is an essential part of your clinical trials communication strategy
- Consider not just providing information but practical ongoing support to help caregivers to support patients in adhering to the protocol
- Cover all aspects of the trial – from how to take medication, to spotting signs and symptoms, and how to cope when the trial ends.