The role of caregivers in clinical trials

Caregivers are usually defined as family members or friends of a patient who provide him or her care and attention (usually unpaid and at home). Depending on the complexity of the disease and the state of health of the patient, this care can be emotionally, physically and financially exhausting. It is usually seen that aggressive diseases, such as cancer, in which the patient’s health deteriorates rapidly, cause a significant amount of stress on the caregivers. Usually, they have to spend several hours a day taking care of them and watch them deteriorate rapidly. In chronic illnesses, it has been shown that the stress is less because the care the family members or friends provide to the patient is usually fewer hours per day in a longer period of time in which the patient deteriorates gradually. This gives certain time for the caregivers to prepare for the end stages of the chronic illnesses, therefore, making it a little bit easier compared to more drastic scenarios in which the patient is expected to have a short-term survival.

In clinical trials, it is very important to consider the caregivers as well, not only the patients. It is advisable that at least two caregivers are present throughout the patient’s participation in the clinical trial. When the doctors participating in the clinical trial talk to the patient and the caregivers, it is important to always pay attention also to the caregiver, not only the patient. Doctors should let caregivers know if there are any responsibilities they should comply with regarding the patient’s care, such as, attending the protocol visits, complying with the treatment, completing patient diaries, etc. Caregivers should be given information about the disease and its course, as well as any cause in which the patient may be discontinued in the protocol, so they can prepare for further treatment if required.

In our experience at Althian, caregivers are usually family members, typically sons, daughters, and spouses. In the majority of cases, they live with the patient or spend several hours per day with him or her. The caregivers are usually the ones that ask questions about what to do next if the disease gets worse, in order to be prepared. We highly recommend to pay special attention to caregivers who live with the patient and that are dealing with a severe disease, such as cancer, as we have seen it causes a significant amount of stress on them. We recommend also to offer them psychological help if required. The role of caregivers is very important in clinical trials because ultimately, they are the ones that usually are aware of what is happening to the patient and they notice if there are any changes in the patient’s health. This in turn translates to having a better communication of any adverse events to the clinical research site and also, a better protocol compliance.