According to leaders at pharmaceutical corporations, university research facilities, caregiving organizations and clinical trial associations, caregivers are an under-valued asset to the clinical trial experience. That's why John Schall, CEO of the National Family Caregivers Association, has this advice to caregivers: "Insinuate yourself into the process. Make it clear to staff that you are the caregiver. Make suggestions that it be documented in the patient's chart that you are the caregiver and want to be a part of the conversation... Very much put yourself in the middle and make it known you are a part of the process."
The caregiver is critical to the success of a patient's participation in a clinical trial, Schall emphasizes, because the caregiver is the closest and most constant observer of the patient. "It is important that the caregiver know what side effects, physical changes and cognitive changes to be watching for," he says. Even if a change does not seem like something to report, he notes, it may in fact be critical.
This lesson is one I learned the hard way: When my mother was in a clinical trial, constipation was one of the side effects of her medication -- leading to her regular use of over-the-counter laxatives. Toward the end of the trial, my mother began losing bowel control. Because the change was easily attributed to the laxatives, I never considered sharing the matter with the clinical trial leaders. As it turned out, however, the loss of bowel movement actually was a sign that her cancer had progressed.
According to Sue Sheridan, Director of Patient Engagement for Patient-Centered Outcomes Research Institute (PCORI), clinical trial leaders "need to encourage patients and caregivers to speak up," so as to help caregivers effectively support patients through the clinical trial experience. "The caregiver and patient need to know what questions to ask and what to be looking for," she emphasizes.
Gail Hunt, President and CEO of the National Alliance for Caregiving, further recommends that clinical trial leaders take the following steps:
• Speak not only in patient-centered language, but also caregiver-centered language. For example, when discussing protocol, ask the caregiver whether she is able and/or willing to perform certain duties.
• Support the caregiver in figuring out the most effective and realistic way to comply with protocol requirements.
• Explain the medical jargon used throughout the clinical trial. The caregiver needs to understand what the researcher is saying, so as to effectively communicate this information to the patient.
• Guide the caregiver on being an effective observer -- explicitly stating what to look out for, how to identify it and how to respond to it.
• Prepare the caregiver and patient for the emotional aspect of ending treatment, at the conclusion of a clinical trial.
Hunt in fact takes caregiver involvement one step further, asserting that caregivers and patients alike need to participate in the very design of a clinical trial.
"We are finding that [caregivers] are asking some of the best research questions," concurs Sheridan. Clinical trial leaders need to infuse caregiver wisdom "through this whole research process," she adds, "to help produce information that is important to caregivers and patients."
When I asked about the existence of caregiver training programs, clinical trial and caregiving leaders revealed that no such programs are formally in place at this time. They agreed, however, that such programs should exist, to help optimize the caregiver's role and, as such, the effective involvement of patients.
"Daily diaries of pain and physical symptoms get pretty complicated," elaborates Sean Mackey, Chief of the Division of Pain Management at Stanford University. Caregivers not only need to ask about and record all this information, he says, but they also need to ensure that patients take their medications at proper times throughout the day.
"There is an old adage, 'Bad data is worse that no data,'" Mackey continues. "The worst thing that can happen with these clinical trials, from a [research] standpoint, is getting inaccurate data." For this reason, he emphasizes, it is critical to properly train caregivers in managing patient information during the clinical trial process.
As someone who stumbled my way through caregiving a loved one in a clinical trial, I could not agree more. When someone's life is on the line, we must leave as little as possible in the hands of trial-and-error.