**Access to Clinical Trials Closer to Home Using Telehealth Tele-health**

**Access to Clinical Trials Closer to Home Using** 

DOI: 10.5772/intechopen.70205

Sabe Sabesan and John Zalcberg

Sabe Sabesan and John Zalcberg Additional information is available at the end of the chapter

Additional information is available at the end of the chapter

http://dx.doi.org/10.5772/intechopen.70205

#### **Abstract**

The purpose of this chapter is to outline key considerations for increasing access to clinical trials for people with cancer living in rural and remote locations, and outline the contribution of tele-health models to facilitate study activity across rural and remote locations. Regional and rural group of the Clinical Oncology Society of Australia (COSA), the peak multidisciplinary cancer clinician body in Australia, has developed the Australasian Teletrial Model in collaboration with its stakeholders to improve rural access to clinical trials. Benefits of this model are not limited to regional, rural and remote systems. This model has the potential to connect larger centres even within the same city and improve the rate of recruitment of highly specialised clinical trials, including rare cancer trials. This model has been developed in consideration of the requirements for the proper conduct of clinical trials ensuring the protection of the rights and safety of trial participants and quality data for the demonstration of safe and efficacious cancer treatments. Ethical and safe conduct of clinical trials using this model requires that the following aspects are considered and addressed by implementation plans.

**Keywords:** clinical trials, tele-medicine, rural, tele-trials, tele-oncology

### **1. Introduction**

Access to specialist cancer care services is a significant issue faced by residents of rural, remote, indigenous and some regional communities in countries with large rural and outer metropolitan populations [1]. For these communities, the lack of access to specialist services may be due to a lack of specialist oncologists locally, limited scope of practice of other rural health professionals and/or overall rural workforce shortages. Poor access to such specialised health care services could be one of the contributors to the disparity in survival and

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© 2016 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons

disease-related outcomes that exist between metropolitan and non-metropolitan patients [2–5], although the authors acknowledge this issue as complex and may also relate to other factors such as behavioural or cultural factors.

It is recommended by leading authorities, such as the National Comprehensive Cancer Network (www.nccn.org) and Cancer Research UK [6], that support for the provision of clinical trials to people diagnosed with cancer is a core component of providing optimal cancer care through specialist cancer centres, hospitals and other treatment facilities. Indeed, in many cases such guidelines recommend participation in clinical trials as the best option for many cancer patients.

Clinical trials offered to people diagnosed with cancer may include new and experimental drug therapies or imaging technologies, minimally invasive diagnostic or surgical techniques, or supportive care interventions. However, as with access to specialist care, patients living outside of major metropolitan centres face many barriers in accessing clinical trials. Barriers to participation include the limited availability of trial sites closer to home and the increased cost and inconvenience of travel to major centres where the trials are taking place [7, 8].

When a patient is assessed as fit for chemotherapy or targeted therapy, medical oncologists write the care plan and send the prescriptions to rural sites where chemotherapy is given by chemotherapy-competent nurses. Where electronic systems are available, care plans are made and approved online. For oral chemotherapy, authority scripts are sent by medical oncologists to patients, rural hospitals or the local pharmacy after appropriate education by medical oncologists, nurses or pharmacists. Prior to the clinic, informed consent for participation in

**Figure 1.** A model of a rural specialist unit with specialist support via tele-medicine model of care. Sabesan et al. EJCC,

Access to Clinical Trials Closer to Home Using Tele-health

http://dx.doi.org/10.5772/intechopen.70205

159

While the models mentioned above are largely medical tele-health models, models such as the Queensland Remote Chemotherapy Supervision (QReCS) model [19] enables rural generalist nurses to administer chemotherapy at rural sites with the support of the rural generalist doctors and pharmacists, under the supervision of medical oncologists and chemotherapy-competent nurses from larger centres using tele-medicine and tele-nursing respectively (**Figure 2**) [20].

the tele-oncology clinic is obtained from the patients.

**1.2. Remote chemotherapy supervision model**

**Figure 2.** Remote chemotherapy supervision model.

2015.

While it may be reasonable to establish clinical trials units in large regional cancer treatment centres, the logistics of maintaining a suitably trained workforce and undertaking the ethical and regulatory responsibilities of clinical trials may be difficult in smaller rural and regional sites with limited resources and low patient numbers.

Tele-oncology models of care have been shown to satisfy many specialist health care needs of rural and regional patients in countries with large rural populations [1]. Using tele-oncology models, many cancer centres have been able to facilitate the administration of complex chemotherapy in rural and regional areas [9–11]. Around the world, such centres have implemented safe and successful tele-oncology models that are acceptable to patients, families and health professionals, saved money for health service provision and enhanced the capabilities of rural health systems in oncology services to provide cancer care [10, 12–17]. In addition, cancer services can be delivered to rural patients closer to home in a timely manner [18]. Teleoncology models of care may outline a system-level intervention to address issues of equity and access to clinical trials. For example, adopting this model would enable rural and regional sites with limited resources to provide access to Phase III comparative effectiveness studies and potentially trials of new and novel therapies for the local population.

This document outlines a feasible and effective tele-health strategy to increase access to clinical trials closer to home, while at the same time ensuring the proper conduct of cancer clinical trials.

#### **1.1. Overview of established clinic and treatment models of tele-oncology in Australia and globally**

Similar to most of the specialist tele-health models around the world, the Townsville teleoncology [15] model enables medical oncologists from Townsville, Australia to provide their services to rural sites, using traditional videoconferencing technology or web-based systems (**Figure 1**). At larger rural centres, rurally-based doctors, chemotherapy-competent nurses and allied health workers accompany patients during tele-consultations. At other rural sites, patients are accompanied by either a doctor or a nurse for post-treatment reviews, toxicity reviews or follow-up visit(s) tele-consultations [12].

**Figure 1.** A model of a rural specialist unit with specialist support via tele-medicine model of care. Sabesan et al. EJCC, 2015.

When a patient is assessed as fit for chemotherapy or targeted therapy, medical oncologists write the care plan and send the prescriptions to rural sites where chemotherapy is given by chemotherapy-competent nurses. Where electronic systems are available, care plans are made and approved online. For oral chemotherapy, authority scripts are sent by medical oncologists to patients, rural hospitals or the local pharmacy after appropriate education by medical oncologists, nurses or pharmacists. Prior to the clinic, informed consent for participation in the tele-oncology clinic is obtained from the patients.

#### **1.2. Remote chemotherapy supervision model**

disease-related outcomes that exist between metropolitan and non-metropolitan patients [2–5], although the authors acknowledge this issue as complex and may also relate to other

It is recommended by leading authorities, such as the National Comprehensive Cancer Network (www.nccn.org) and Cancer Research UK [6], that support for the provision of clinical trials to people diagnosed with cancer is a core component of providing optimal cancer care through specialist cancer centres, hospitals and other treatment facilities. Indeed, in many cases such guidelines recommend participation in clinical trials as the best option for

Clinical trials offered to people diagnosed with cancer may include new and experimental drug therapies or imaging technologies, minimally invasive diagnostic or surgical techniques, or supportive care interventions. However, as with access to specialist care, patients living outside of major metropolitan centres face many barriers in accessing clinical trials. Barriers to participation include the limited availability of trial sites closer to home and the increased cost

While it may be reasonable to establish clinical trials units in large regional cancer treatment centres, the logistics of maintaining a suitably trained workforce and undertaking the ethical and regulatory responsibilities of clinical trials may be difficult in smaller rural and regional

Tele-oncology models of care have been shown to satisfy many specialist health care needs of rural and regional patients in countries with large rural populations [1]. Using tele-oncology models, many cancer centres have been able to facilitate the administration of complex chemotherapy in rural and regional areas [9–11]. Around the world, such centres have implemented safe and successful tele-oncology models that are acceptable to patients, families and health professionals, saved money for health service provision and enhanced the capabilities of rural health systems in oncology services to provide cancer care [10, 12–17]. In addition, cancer services can be delivered to rural patients closer to home in a timely manner [18]. Teleoncology models of care may outline a system-level intervention to address issues of equity and access to clinical trials. For example, adopting this model would enable rural and regional sites with limited resources to provide access to Phase III comparative effectiveness studies

This document outlines a feasible and effective tele-health strategy to increase access to clinical trials closer to home, while at the same time ensuring the proper conduct of cancer clinical trials.

**1.1. Overview of established clinic and treatment models of tele-oncology in Australia** 

Similar to most of the specialist tele-health models around the world, the Townsville teleoncology [15] model enables medical oncologists from Townsville, Australia to provide their services to rural sites, using traditional videoconferencing technology or web-based systems (**Figure 1**). At larger rural centres, rurally-based doctors, chemotherapy-competent nurses and allied health workers accompany patients during tele-consultations. At other rural sites, patients are accompanied by either a doctor or a nurse for post-treatment reviews, toxicity

and inconvenience of travel to major centres where the trials are taking place [7, 8].

and potentially trials of new and novel therapies for the local population.

factors such as behavioural or cultural factors.

sites with limited resources and low patient numbers.

reviews or follow-up visit(s) tele-consultations [12].

many cancer patients.

158 Clinical Trials in Vulnerable Populations

**and globally**

While the models mentioned above are largely medical tele-health models, models such as the Queensland Remote Chemotherapy Supervision (QReCS) model [19] enables rural generalist nurses to administer chemotherapy at rural sites with the support of the rural generalist doctors and pharmacists, under the supervision of medical oncologists and chemotherapy-competent nurses from larger centres using tele-medicine and tele-nursing respectively (**Figure 2**) [20].

**Figure 2.** Remote chemotherapy supervision model.
