Decentralized Clinical Trials at Home: Commentary on Caregivers’ Burden

Abstract

Decentralized clinical trials (DCTs) provide the opportunity to bring interventional studies closer to participants in their homes or a suitable location closer to prospective participants, thus increasing participants’ diversity, accrual, retention, health care, and research access. However, little is known about the burden of caring for cancer patients participating in DCTs. This article describes how DCTs might affect the caregivers of cancer patients. The points discussed include how technological challenges for those without adequate digital literacy can overburden participants and their caregivers at home, as well as managing and optimizing research logistics and safe handling of samples. In addition, the shift in labor from the study personnel to the participants and their caregivers in a bid to complete several study procedures on their own can increase the care burden, especially if not well incentivized. Therefore, it is important to accumulate evidence on ways to optimize DCTs, especially in the home environment, without increasing the burden on caregivers, who will be an integral part of the study team and support the research at home.

Background

Decentralized Clinical Trials (DCTs) are interventional studies that are not confined to hospital walls but are brought closer to participants in their homes or a suitable location closer to prospective participants. ¹ These locations can range from community pharmacies to community health hubs and homes of patients in some instances, with care and some data collection administered remotely by the study team. The lessons learned during the pandemic have accelerated the advancement in technology and protocols to accommodate remote care and data collection to support DCT. ² The potential benefits for studies with DCT design include access to a diverse population, participant retention, reduced participation burden in terms of logistics and social determinants of health in part of the participants, and reduction in the overall cost of trials in the part of the institution.^2,3 Furthermore, DCT holds promise in reaching more diverse participants, ⁴ including the communities that traditionally have not been represented in most trials. ⁵ The recent analysis of clinical trial participation globally showed that only 7% were Blacks, while 76% of participants were White, and 11% were Asian. ⁶ The underrepresentation of Blacks has been linked to mistrust in science and investigators due to the previous overreach of clinical investigators. Another important barrier to the participation of Blacks in clinical trials is social determinants of health, including inadequate access to trials due to geographical constraints. Most academic medical centers are in urban areas, disenfranchising those living in rural communities with poor transportation logistics. ⁴ Thus, decentralization is a novel and emerging concept that holds great promise in clinical research and trials. Emerging evidence has favored the benefits of DCTs in increasing participants’ diversity, accrual, retention, health care, and research access. While the advantages of DCT in addressing clinical trial diversity cannot be contended, little attention has been paid to its impact on the shift of more responsibilities to participants and/or caregivers, especially for trials focused on cancer patients or survivors. In this paper, we provide perspectives on the burden of caregivers.

A caregiver is any relative, partner, friend or neighbor who lives with or separately from a patient and has a significant personal relationship with the patient and provides a broad range of assistance for cancer patients in this context. They may be primary or secondary caregivers and live with or separately from the person receiving care. DCTs targeting cancer patients/survivors may need the involvement of participants’ relatives and family members, who play a vital role in the physical, functional, and emotional well-being of the DCT participants. ⁷ Family caregivers provide care and support to their loved ones from diagnoses through survivorship. This role can be burdensome because caregivers share the disease burdens with their care recipients. Caregivers are also involved with maintaining the home environment and domestic activities, and sometimes also need to keep up with jobs, resulting in caregiver burden and stress, and most are unprepared for their caregiving role and do not know what to expect. ⁸ Health information and caregivers’ burden have been identified as important factors guiding treatment decision-making. ⁹

Perspectives on how DCTs Might Impact Caregivers

Increased Care Burden of Caregivers of Cancer Patients in DCT

The caregiver burden has been identified as a source of stress and anxiety ¹⁰ and is the most important concern for quality of life (QOL) throughout the cancer care continuum. ¹¹ The multidimensional aspects of caring for cancer patients can significantly increase the care burden for family caregivers, who often play a critical role in treatment and survivorship. ¹² In DCTs, most of the trial logistics shift from clinical settings to the homes of the patients, placing additional responsibility, especially complexities of intervention delievries ¹³ on caregivers who must balance their caregiving duties with the demands of the trial. Caregivers’ burden may also be affected by financial burden, ¹⁴ inadequate information, communication challenges with health care providers, cancer progression, protocols, and hospital policies. ¹⁵ Some of these burdens may be potentially addressed by considering a patient and caregiver-responsive DCT treatment at home, which can range from partial to full decentralization of study.

Advancements in technology and innovations in the health care system in terms of state-of-the-art equipment/resources, as well as an outstanding health workforce, provide the platform for successful DCTs. Therefore, DCT designs should include actionable measures put in place to ensure study activities do not increase the stress and care burden of patients and caregivers. Some considerations of DCTs should be put in perspective. Therefore, cancer-related DCT must ensure robust caregiver support through regular study team check-ins, utilizing responsive technology and artificial intelligence to promptly address any source of concerns and stress.

Logistics and Technology Challenges in DCT

As DCTs rely heavily on the regular use of computers and/or mobile devices, including equitable broadband access, digital access and literacy have become greater concerns. ¹⁶ Evidence from a DCT qualitative study highlighted participants and their caregivers can feel overburdened by the need to keep up with many technologies and devices. ¹⁷ Technological advances are leveraged to facilitate the smooth operation of DCTs; however, these must be carefully evaluated from the perspectives of patients’ and caregivers’ to avoid adding stress. Study participants and their caregivers will need to be properly trained on how to operate the devices and how to troubleshoot when necessary. ¹⁸ Setting up the home environment for DCT includes connectivity for electronic health records, real-time video conferencing, smartphone health applications, and/or remotely connectable health monitoring devices, depending on the DCT. Appropriate home setup must consider patients’ and caregivers’ literacy levels and home readiness for digital enablement. Without appropriate support, troubleshooting technology issues may increase caregivers’ burden and subsequently impact caregiving for the patient/survivor. Moreover, personalized but relevant tech support should be integrated into the DCT protocol, providing tutorials for specific apps or equipment to prevent confusion or frustration. ¹⁹

Expanded Role of Medical Management in Addition to Optimizing Research Logistics

In cancer-related DCT, the caregivers of the participants have additional roles in the health care management of their care recipients, which might include tracking health data, ensuring medication adherence, and reporting symptoms. ¹⁸ This additional role increases the time commitment requirement for caring for a loved 1 participating in DCT, resulting from the need for frequent or longer interactions with digital platforms and devices necessary to track medical data.^17,20 This can be addressed by providing user-friendly resources such as sufficient training sessions, video tutorials, and very simple guides to help caregivers. Additionally, flexible scheduling is essential to help reduce the stress for caregivers of DCT participants. The establishment of clear expectations regarding time commitments should also be communicated from the outset. Regular physical and or virtual check-ins by the care team and research staff can provide valuable support, helping to ease anxiety around self-managing certain aspects of care and research logistics.

In traditional research settings, where hospitals host research studies, the logistics of study administration of investigational products, delivery, storage, use, disposal, and return of medicinal products and devices, as well as data collection, are carried out by study personnel following protocols. ¹⁵ Issues of safe handling of samples and participants’ safety and reporting adverse events are also handled by trained professionals. However, these are not the same in DCTs. Participants and their caregivers will need to assume some of the roles of study coordinators and other professionals for data and sample collection, investigational product delivery, storage, use, and disposal, electronic data computation, video visits set up at home, etc. Balancing trial responsibilities alongside daily routines, work, family commitments, and caregiving duties can be particularly challenging. ¹⁵ However, user-friendly technology and artificial intelligence (AI), such as AI-powered apps, automated data collection methods, and flexible trial schedules, can help reduce the burden of caregivers.^20,21 Adequate accommodation for the orientation on how safety and risk mitigation conditions are met must be spelled out in the study protocol. ²² In addition, the time and effort required to ensure that all protocol requirements are met can add to the already high burden of care for caregivers. This burden may be amplified by the fact that caregivers may also have a health condition, limitations in mobility, or a cognitive disruption. The burden of study logistics can be reduced if self-samples and data collection are restricted to simple, non-invasive procedures or are done by specialized personnel who can provide home service. With respect to both product handling and biological samples, participants should be provided with comprehensive instructions, for instance, through dedicated apps or websites, with user-friendly communication tools, such as visual aids, infographics, and videos. ¹⁸

Labor Dynamics and Financial Incentives

In conventional research settings, participants are generally incentivized through financial reimbursements for the expenses directly associated with trial participation, while study staff are compensated for the services they render. However, direct costs of trial participation are arguably reduced in DCTs because participants will complete several study procedures on their own, thus creating a shift in labor from the study personnel to the participants and their caregivers. This shift in labor can increase the physical and emotional strains, thereby increasing the care burden, especially if not well incentivized, ²² as caregivers will have to manage care and research logistics of DCT at home. To avoid the exploitation of participants’ time and financial resources, there is a need to carefully assess the direct and indirect costs of the study to the participants and cover data costs, equipment, or transportation to nearby testing facilities when needed. It will also be critical that patients and family caregivers do not feel they are providing extra services for which they receive no corresponding compensation. ²³ Navigation to community and virtual support groups and contact with trial coordinators for encouragement can help mitigate feelings of isolation and reduce anxiety. It is also important to provide access to mental health resources to help manage emotional strain when necessary.

Future Directions

As important stakeholders in the health care system continue to advance innovations to drive clinical trials with state-of-the-art equipment/resources, paving the way for more decentralization across the cancer care continuum, there is a need to consider the burden to patients and their caregivers. Some studies found that the quality of caregiver’s care and support impact patient outcomes.²⁴ Caring for patients with cancer imposes considerable demands upon the caregiver’s health.²⁵ Unfortunately, little is known about the burden of caring for cancer patients participating in DCTs. It is important to accumulate evidence on how to optimize DCTs, especially in the home environment, without increasing the burden on caregivers, who will be an integral part of the study team and support the research at home. This will advance the science and design of effective DCTs for cancer patients. There is a need for health and research economics studies that would elucidate the impact of DCT on caregivers, who might have greater responsibilities to support patients’ participation and research outcomes.