Members of the HD community who have taken part in research understand the challenges that come with participating in a study. Whether they are observational or clinical, the studies are critical to advancing science and finding new beneficial therapies, although they each come with their own stressors. Enrolling requires participants to place a great deal of trust in the research team, clinical trial site, and study sponsor — often before the first visit even takes place. Still, given the high stakes, it’s understandable that individuals with HD are willing to take on that burden for the possibility of accessing a therapy that improves their life.
Those impacted by HD experience stress of varied intensity and type across their life course. Participating in a clinical trial potentially increases hope, but must be balanced with the realities of the health risks, time commitment, scheduling, travel, care for children, care for adults, work coverage, effort to complete all of the study protocol, and other individual factors for each participant.
Clinical trial participation selection has historically trended towards those with higher income and education due to various factors, including the greater burden of participation for those who are chronically over-stressed and under-resourced. As interventional trials for HD become more complex, potentially invasive, and ultimately demanding, considerations must be made for the participants to address their psychosocial needs in support of their participation and long-term well-being.
Many people with HD are referred to trial sites for screening through their HDSA Center of Excellence (COE) care team, a Huntington Study Group (HSG) site, advocacy organizations, support groups, families, and other relationships. Despite these supportive connections, the psychosocial stress, anxieties, and disruptions to routine that can occur as part of the process persist and necessitate individualized support.
Depending on the participant’s psychosocial resources, such as access to a mental health provider, they may have minimal knowledge of HD care and research. Additionally, some research participants reduce their use of clinical care and their supportive resources while participating in research due to two main changes: the trial limits their available time and they may have a lower perceived need, since they see their research team frequently.
The clinical trial navigation service created by HD Genetics provides participants and their study companions with one-to-one support by a licensed social worker throughout the trial.
Spearheaded by the team at HD Genetics and the Huntington Study Group, the Clinical Trial Navigator (CTN) is a role available to contract research organizations (CROs) and study sponsors, engaged when initiating trials with new sites and participants. The CTN should be clinically licensed to provide these services in the territory where the research site is located. They are experienced in HD care and research and prepared with background in behavioral health care and psychosocial support. It is critical that the CTN navigator is versatile, as they address the varied needs of participants coping with stress, anxiousness or misunderstanding through complex protocols and sometimes lengthy studies.
From the participant’s perspective, the CTN can provide accessible psychosocial support throughout the duration of the trial and can coordinate resources or provide feedback to the research team and CRO. For participants, utilizing a CTN is not required, but the offer is made by introduction through their trusted study team and funded by the study sponsor so that cost does not burden participants and discourage use of the service. From the sponsor’s perspective, a CTN offers the advantage of providing unbiased psychosocial support and assessment, all in support of the participant’s experience and retention.
The CTN is available via multiple modes of communication including call, messaging, and scheduled video chat, so that participants can communicate asynchronously at their convenience and reliably receive a response. Similarly, when consenting, the participants can agree for the CTN to communicate across their research team and CRO. Utilizing clincierge to allow them to relate their experience and, when appropriate, improve upon it for future participants.
Ensuring that participants are able to optimize their psychological well-being and function throughout a trial is part of the responsibility of study teams. Extending resources such as CTN to participants and companions respects the requirements being made of these families and conveys care for the HD community’s experience.