Terminal Illness Care & Treatment

Psychedelics administered in controlled and therapeutic settings have, in many cases, alleviated anxiety surrounding death, increased feelings of connectedness, increased ratings of death acceptance, and induced mystical or spiritually significant experiences for individuals at the end of life. While substances such as psilocybin, which is the active ingredient in “magic mushrooms” and other psychedelic drugs, are currently being studied in clinical trials for the treatment of psychiatric disorders and chronic diseases, their potential use in end-of-life settings is not yet fully realized. 

Researchers believe that taking psychedelics provides terminally ill patients with a sense of peace and acceptance regarding the inevitability of their death. This may occur through confronting their fears, new insights into their understanding of their mortality, or an existential or spiritual experience that may help them find meaning or purpose through a new perspective. MDMA-assisted therapy has similar benefits in reducing anxiety and fear, promoting emotional resilience, gaining a sense of reconnection to life, and improving quality of life.

Although there are many promising findings surrounding the use of psychedelics among terminally ill patients, the emergence of psychedelic medicine is in its early stages, with active development resulting from ongoing research and clinical trials. Research is necessary to fully understand the potential efficacy, long-term effects, and safety of the use of psychedelic substances in individuals with life-threatening or end-stage diseases. Additionally, many regulatory and legal barriers limit the more widespread compassionate use of psychedelic-assisted therapy across patient populations. Despite these challenges, the potential benefits of using psychedelics to relieve death anxiety are slowly gaining increased interest and support among patients, researchers, and healthcare professionals. 

Sources

“Psychedelics May Lessen Fear of Death and Dying, Similar to Feelings Reported by Those Who’ve Had Near-Death Experiences”. Johns Hopkins Medicine. https://www.hopkinsmedicine.org/news/newsroom/news-releases/2022/08/psychedelics-may-lessen-fear-of-death-and-dying-similar-to-feelings-reported-by-those-whove-had-near-death-experiences 

“Facing death, returning to life: A qualitative analysis of MDMA-assisted therapy for anxiety associated with life-threatening illness”. National Library of Medicine. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9552520/

“Dying Patients Are Fighting for Access to Psychedelics”. Time. https://time.com/6208079/psychedelics-psilocybin-access-end-of-life/

Numerous studies have found that cannabis, or marijuana, can be effective in managing symptoms of loss of appetite, nausea, and pain in patients with terminal illnesses such as cancer. These benefits are largely achieved through the active compounds in cannabis, such as tetrahydrocannabinol (THC) and cannabidiol (CBD), which can provide a variety of therapeutic effects in the body. A wide range of available strains and types of cannabis results in different amounts and active compounds present in the plant itself, which can influence the effects experienced after intake. 

Opioids and other strong medications are often prescribed for pain management in patients with cancer, but sometimes result in problematic side effects such as constipation and, rarely, respiratory depression. While these side effects can be effectively managed by a knowledgeable care team, promising findings from a recent study showed that augmenting these medications with cannabis enhanced pain management while also reducing the amount of opioids needed. Constipation was also relieved due to the lower dose of opiates. Some studies have also suggested that THC and CBD can slow the growth of or destroy certain types of cancer cells in the laboratory, although these options are not approved for the management of cancer. 

Cannabis has also been used to ease existential and spiritual suffering at the end of life. Terminal illness can cause intense feelings of sorrow, hopelessness or anxiety. In some individuals, cannabis use can produce a sense of calm or euphoria which temporarily eases this emotional suffering. However, both the dosage and chemical makeup of cannabis compounds is an important consideration in this regard. Higher concentrations of THC, in particular, can actually increase anxiety in sensitive individuals, so care should be taken to ensure that the person receives an appropriate dose. 

Although ongoing research includes many promising findings regarding the use of cannabis in patients with terminal illnesses, there are still concerns about its use. For example, FDA-approved cannabinoid drugs such as Dronabinol and Nabilone provide many of the benefits discussed here, but may cause side effects such as increased heart rate, dizziness, fainting, or the worsening of anxiety or depression in some individuals. Additionally, while 38 states and the District of Columbia have legalized the use of medically approved cannabis, the federal government still designates cannabis as a Schedule I drug with “no medically acceptable use and a high potential for abuse” thus limiting the ability of federally funded research into its benefits and risks. 

Sources

“Marijuana and Cancer”. American Cancer Society. https://www.cancer.gov/about-cancer/treatment/cam/patient/cannabis-pdq

“Medicinal Cannabis Can Safely Relieve Cancer Pain and Curb Total Meds Use”. BMJ. https://www.bmj.com/company/newsroom/medicinal-cannabis-can-safely-relieve-cancer-pain-and-curb-total-meds-and-opioid-use/

“Anxiety and Cannabis, A Review of Recent Research: April 2023”. Drexel University Medical Cannabis Research Center. https://drexel.edu/cannabis-research/research/research-highlights/2023/April/anxiety_cannabis_fact_sheet/ 

Pathways: “Is Medical Marijuana Beneficial For End of Life Care?” Pathways Health.https://pathwayshealth.org/is-medical-marijuana-beneficial-for-end-of-life-care/ 

“State Medical Cannabis Laws”. National Conference of State Legislatures.  https://www.ncsl.org/health/state-medical-cannabis-laws

In the United States, hospice care is available to any individual who, in the opinion of two physicians, has a life expectancy of six months or less. Although many individuals choose hospice care after pursuing curative treatments for some period of time, prior attempts to cure an underlying illness or illnesses is not a prerequisite. Persons wishing to enter hospice must choose to forgo potentially curative treatments such as cancer chemotherapy or kidney dialysis. However, they will still receive medically necessary treatment that is aimed at symptom control and improved quality of life. 

With that being said, every person is different, and there is no pat answer as to when it is appropriate to change the goals of care. Much depends on each individual’s circumstances and what they hope to accomplish in the time they have left. One person, for example, may want to do everything possible to stay alive until their grandchild is born or their son graduates from medical school. To them, the side effects of another round of chemotherapy or additional treatments to try to buy a little bit more time may make perfect sense. Another person in a similar situation may have accepted the fact that their disease has run its course and want nothing more than to be as comfortable as possible until their life comes to a natural end. 

If you and your care partners are considering hospice, you may first wish to discuss your thoughts with a palliative care specialist who can help you define your goals and determine whether hospice care is right for you at this time. A palliative care doctor may also help you obtain a hospice referral or guide you in advocating for a referral from your treating physician if that is what you decide is best.  

According to the Center to Advance Palliative Care, palliative care is specialized medical care that aims to relieve symptoms and emotional distress in patients and families living with a serious illness. The care is typically delivered by a palliative care team that includes a physician, a nurse (or several nurses), a social worker, a chaplain and other professionals, such as physical and occupational therapists, as needed. Some teams also include a registered dietician, a psychologist or psychiatrist, and a team of integrative therapists, such as massage therapists, aromatherapists and acupuncturists. Translator services are typically available for non-English speaking patients as well. 

Unlike hospice care, which is generally reserved for patients who have fewer than 6 months to live, palliative care is appropriate for anyone living with a serious illness regardless of their prognosis. It can be started at the time of diagnosis and continued alongside curative care. 

Palliative care revolves around the patient and their family — the focus is on identifying and alleviating sources of discomfort and stress throughout the course of the disease. This requires ongoing assessment and regular follow-ups because these sources are not stagnant. What the patient and their loved ones need at the time of the diagnosis may be very different from their needs as the patient approaches the end of life. Although the scope of care they provide is very broad, issues the team can help address include the following:

• Physical issues, such as fatigue, pain, shortness of breath, nausea and vomiting, loss of appetite and difficulty sleeping. Doctors can prescribe medications to address many of these symptoms, while other healthcare professionals can add more layers of support, such as massage, nutrition counseling, positioning and breathing techniques. 

• Emotional issues, such as fear, anxiety, depression and despair. Some of these issues can be addressed with medication, and mental health professionals can provide counseling, referrals to support groups and other kinds of support as well.

• Practical concerns, such as financial worries, insurance issues, child care, housing or transportation needs. As a rule, the palliative care social worker will help the family navigate these systems, find appropriate resources and request aid. 

• Spiritual needs, which become more important to many people who are facing a serious illness. Chaplaincy services offer spiritual counseling or simply provide a safe place for the patient and their family to discuss their values and goals. 

If you believe palliative care can help you or your family cope with your illness, speak with your doctor about a referral to a palliative care team. Most medical centers in the U.S. offer a palliative care service, although many only provide care to patients who are hospitalized. With that being said, more and more centers are developing outpatient palliative care teams for  patients with serious illnesses such as cancer, heart disease or COPD. Ask your primary care doctor what’s available in your area, or, if you’re hospitalized, ask to meet with the nurse case manager to explore what options are available to you. 

Sources
“What is Palliative Care?” The Center to Advance Palliative Care.  https://getpalliativecare.org/whatis/

The federal Right-To-Try Act gives terminally ill patients access to experimental medications that are not yet FDA-approved. This law means those diagnosed with a terminal illness have a right to acquire unapproved medications or biologics that may alleviate their specific condition or prolong life. The bill was signed into law by President Donald  Trump on May 30, 2018, granting patients access to investigational drugs when all other treatments or clinical trials have been exhausted. While 38 states had previously passed similar laws, this Right-To-Try law is nationwide.

The law requires that patients meet certain qualifications to be eligible for participation: 

• The patient must be diagnosed with a terminal disease or condition 
• The patient must have exhausted all approved treatment options.
• The patient must be deemed ineligible to participate in clinical trials that might otherwise lessen or cure their disease.
• The experimental drug must have already passed FDA phase 1 clinical testing
• The pharmaceutical manufacturer must approve the use of the drug as an experimental treatment
• A treating physician or health care provider must recommend and approve the use of the drug for the patient.
• The patient must provide written informed consent regarding risks associated with the treatment

It is important to note that Right-To-Try medications do not include those that may be prescribed for off-label use by a physician, as these drugs are already approved by the FDA for other conditions.

Key considerations before you pursue right-to-try medications

Under the Right to Try Act, pharmaceutical companies and physicians are immune from liability. Therefore, patients should have a full understanding of the pros and cons associated with any experimental treatment. The information provided by pharmaceutical companies can often be technical, or contain language that is difficult for the average person to grasp. Patients should always seek advice from their healthcare provider about the risks, benefits and alternatives to any treatment they seek. 

Additionally, while the outcome of experimental therapies may be beneficial or even lifesaving for some terminally ill patients, misconceptions about their projected success rate can foster a false sense of hope. Further, since these therapies have only been tested in small clinical trials, the scope of potential side effects and toxicities is largely unknown. These effects can be significant and potentially worsen a patient’s condition or cause serious detriment to their quality of life. 

Paying for right-to-try medications

According to the FDA, drug companies do have a right to charge for investigational products. Before accessing a right-to-try treatment, patients should check with their health insurance provider to verify what will be covered and what will not. Most often, insurers, including Medicare and Medicaid, do not cover the cost of these medications.

Sources

“S.204 – Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017”. Congress.gov. https://www.congress.gov/bill/115th-congress/senate-bill/204/text

“Development & Approval Process | Drugs”. U.S. Food & Drug Administration. https://www.fda.gov/drugs/development-approval-process-drugs

“What Are “Biologics” Questions and Answers”. U.S. Food & Drug Administration. https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers

“Assessment of the Right-to-Try Law: The Pros and the Cons”. The Journal of Nuclear Medicine. https://jnm.snmjournals.org/content/59/10/1492

The FDA Expanded Access Program, also known as Compassionate Use, is an option that allows patients with terminal illnesses to try investigational medical products as treatments outside of clinical trials if there aren’t any comparable therapies that can be used instead. Investigational medical products are defined as drugs, biologics, or medical devices that are currently being tested to determine whether they are safe and appropriate for use in patient populations. Since these products are being tested, they have not yet been approved by the FDA. As a result, there aren’t any guarantees that the product will be effective in the treatment of the condition, and there is a possibility that using the product may cause adverse reactions. 

Being eligible for expanded access does not always guarantee that a patient will receive an investigational medical product. For example, sometimes there are limited amounts of medications available for compassionate use, such as if a pharmaceutical company only has enough medication for a clinical trial. Additionally, although expanded access is legal, it is limited to specific patients based on criteria. All of the following criteria must be met for expanded access to be deemed an appropriate option: 

• The patient must have a life-threatening or serious disease or condition
• The potential benefit to the patient is significant in comparison to the potential risk 
• It is not possible for the patient to enroll in a clinical trial 
• There isn’t a satisfactory or comparable alternative therapy for the disease or condition 
• Providing the investigational medical product will not interfere with any investigational trials to support product development or marketing approval for treatment indications 

It is important to note that the FDA Expanded Access Program is not the same as the Right to Try Act, which was passed in 2018. Although the Right to Try Act is another option that patients may use to have access to medications that have not yet been approved by the FDA, the eligibility criteria differ from expanded access, and medications that may be provided through Right to Try have already been used in Phase I clinical trials. 

Sources

“Compassionate Drug Use.” American Cancer Society. https://www.cancer.org/cancer/managing-cancer/making-treatment-decisions/clinical-trials/compassionate-drug-use.html 

“Expanded Access.” U.S. Food and Drug Administration. https://www.fda.gov/news-events/public-health-focus/expanded-access#:~:text=Sometimes%20called%20%E2%80%9Ccompassionate%20use%E2%80%9D%2C,trials%20when%20no%20comparable%20or 

“Expanded Access: Information for Patients.” U.S. Food and Drug Administration. https://www.fda.gov/news-events/expanded-access/expanded-access-information-patients

First, knowing why you want to participate in a clinical trial with a terminal illness and what you hope to gain from the experience can help you to decide which trial may be best for you. Are you hoping to cure your disease or slow it down? Do you want to reduce pain or other symptoms? Or, perhaps you want to participate so researchers might develop better outcomes for others with your disease in the future.

Although participation in a trial may be more difficult or challenging for terminally ill patients, exercising autonomy in decision-making when it comes to research participation can be beneficial. According to a literature review published in Sage Palliative Medicine, there are many reasons why patients with a terminal illness choose to participate in trials. These include:

• It appeals to them on some personal level
• It provides a sense of contributing to scientific research; a desire to help others
• The trial may provide tangible or potential benefits; for example, studies on aromatherapy, special mattresses, or relaxation techniques could provide more enjoyable and immediate results
• It could help ease or better manage symptoms
• Participation is easy with little risk involved
• Study is non-invasive 
• The trial provides social interaction during participation

Whatever the reason, the main objective of any trial should be to meet your own personal goals.

Before beginning your search for clinical trials

There are many factors to consider before deciding which trial may be the best fit for you. Below are a few things you should keep in mind as you begin your search.

• Eligibility – Researchers will need to determine if you meet criteria set for any trial. Gathering medical details about your diagnosis, prognosis and health records may be helpful. Sometimes previous curative treatments, side effects or current symptoms can disqualify you from participating, so it is good to have that information on hand.

• Location – You should consider how you will manage any travel that may be required for you to participate. Some trials may involve scheduled hospital visits, periodic diagnostic testing, lab work, injections or other treatments at one or multiple locations. How far or how often are you willing to travel and how will you get there and back?

• Duration – Think about the level of commitment you are willing to make and set expectations on how long you would be willing to participate. Is a one-time trial ideal, or will a weeks-long or months-long trial be something you might also consider? How long are you willing to participate on an ongoing basis?

After setting goals and assessing your ability to participate, you can contact a team running a trial that seems like a good match, or ask your doctor to do so for you. Be aware that some important details may not be readily available within the initial summary, so it is important to ask questions soon after you make contact with them.

Aside from eligibility, location and duration, here are a few additional questions you may want to ask before making a final decision to apply for the trial.

• What is the purpose of the trial?
• What are the possible risks, side effects, and potential benefits?
• What happens if I cannot or do not want to complete the trial?
• How will I, or my family, be informed about the trial results?

The medical team or board will then review your application to decide if you are an appropriate match.

How to find a clinical trial

The most comprehensive database of privately and publicly funded clinical studies around the world can be found at www.clinicaltrials.gov. You can search using a condition or disease, keywords, specific terms and/or location.

Clinical trial listing services like Third Opinion connect patients directly to clinical recruiters at no cost to you. Although most of their available trials may also be listed at clinicaltrials.gov, at these websites patients can create an account and provide details that generate a search of their database for potential matches.  

You can also search national organizations related to your illness or diagnosis that may offer additional avenues to find a relevant trial. The websites of pharmaceutical and biotechnology companies may also show trials that might interest you.  

Your health care provider may also recommend a clinical trial that will meet your needs. 

Sources
“Dying persons’ perspectives on, or experiences of, participating in research: An integrative review.” Sage Palliative Medicine. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6144348/

Although it’s not always necessary to get a second opinion, most experts agree that it is often a good idea. Even doctors who have a great deal of experience can be wrong about a diagnosis. According to one study from 2017, about one in five patients who went to Mayo Clinic for a second opinion left with a completely different diagnosis, and over 60% had their diagnosis corrected in some way.

Another small study that looked at 70 cancer patients who sought a second opinion from a National Cancer Institute-designated cancer center found that 43% of their diagnoses changed. This doesn’t mean the original doctor was incompetent, experts say. It simply points to the reality that diagnosing a serious illness can be complicated, and seeking a second opinion can make a big difference in getting the right care. Certainly, if the first doctor says the illness is terminal, it’s worth making sure they are right. 

Misdiagnosis of a serious illness can also lead to significant harm. According to a 2019 analysis of 11,000 malpractice claims reported in the journal Diagnosis, between 40,000 and 80,000 patients in the U.S. die every year because their medical diagnosis was incorrect. An additional 80,000 to 160,000 persons may suffer severe injury to their health as a result of an incorrect diagnosis, the study found. 

Finding the Best Treatment Options

A second opinion can also be helpful in identifying the best treatment strategy. Even the most competent doctors are not always informed about the latest research, especially if their experience with a particular diagnosis is limited. Further, not every healthcare provider is equipped to offer every option. “Some treatments — particularly clinical trials — may not be offered at every center,” said Dr. Anees Chagpar, MD, MBA, MPH, a breast surgeon at Yale Medicine. “So, while patients may find that two centers offer the same diagnosis and treatment, this is not always the case.”

A second opinion is particularly crucial when you feel unsure about any aspect of the diagnosis you’ve been given or the proposed treatment plan. Specifically, you should ask for a second opinion when you’ve been told you have a life-limiting illness and in the following circumstances:

• You or your doctor are unsure about the diagnosis
• You’ve been diagnosed with a rare condition
• You have several medical problems
• The proposed treatment is experimental, risky or controversial
• You’re concerned about treatment side effects
• You’re not responding to treatment as expected
• You have a choice between treatment options that vary greatly in cost
• You want to explore other treatment options
• Your health insurer requires one

Remember, this is your body and your life, so don’t be shy about asking your doctor for a referral to another specialist who’s familiar with your disease. Any competent doctor will respect your desire to make informed decisions about your care. 

Sources

“Misdiagnosis of the ‘big three’ results in ‘serious harm” . Medical News Today. https://www.medicalnewstoday.com/articles/325811#The-big-three

“Can a Second Opinion Make a Difference?” Yale Medicine. https://www.yalemedicine.org/news/second-opinions