Clinical trials, mental health and digital therapy

In the breast cancer treatment paradigm, precision medicine and emerging therapies have created new opportunities to deal with the physical burden of the disease. However, issues regarding access to these innovative therapies and interventions for mental aspects of diagnosis continue to prove significantly unresolved, particularly in underserved communities nationwide, according to experts interviewed by The American Journal of Managed Care® (AJMC®).

Despite a universal decline in breast cancer death rates, black women continue to experience double the 5- and 10-year death rates compared to white women. Breaking down these notable disparities, issues regarding insurance status, financial well-being, and other social determinants of health have long been cited as contributing to negative outcomes among minorities with breast cancer.

However, biology has also been indicated as a potential reason for these disparities, in which research has shown a growing link between black women and the aggressive subtypes of the disease, such as triple negative breast cancer and cancer. inflammatory breast.

Since black women are also more likely to be diagnosed at a younger age and in more advanced stages of the disease, preventive measures, such as screening, to account for the difference in risk have long been adopted for these populations. . In addition, the applicability of emerging oncology therapies to minority groups raises concerns, as clinical trials conducted to evaluate these therapies have largely excluded these populations.

A recent article from the American Society of Clinical Oncology (ASCO) shows that black patients constituted less than 4% of all patients enrolled in several trials that have supported the approval of immune checkpoint inhibitors for cancer treatment of the lung, with a similar underrepresentation referenced for trials conducted in renal cell carcinoma and other tumor types.

Barriers to Minority Access / Participation in Breast Cancer Clinical Trials

Addressing the lack of representation of minorities in clinical trials, Megan-Claire Chase, Director of Partnerships, GRYT Health, spoke in an email exchange with AJMC® on the barriers specific to patients and clinicians that contribute to these disparities.

As a black woman and breast cancer survivor, Chase pointed to the stigma associated with clinical trials in various communities due to past experiences with Henrietta Lacks and the syphilis experiments on black men in Tuskegee from 1932 to 1972.

“There are many more atrocities like these, and these are spots that stay at the forefront of every black’s mind when he hears the words. clinical test,” she said.

With these doubts already at the forefront of minorities when considering clinical trial enrollment, Chase added that the clinician’s management when diagnosed with breast cancer, especially when trying to ask for l Help during active treatment was a traumatic experience that further contributed to his distrust of clinical trials and the healthcare system.

“I was constantly asked what type of breast cancer I had because it was not triple negative, which is most prevalent in the black community. We are not all the same. It was a bitter discovery to see that racism and prejudice also occur in cancer. “

Although not initially intending to become a patient advocate, these experiences led Chase to create a blog to highlight the challenges of being a young adult cancer survivor and to enable members of various communities to know what to do with it. ‘they and their voices matter.

Specifically, Chase listed 5 things that she believes are justified in improving trust between the medical community and various patients, from the moment they meet in conversations about participating in clinical trials:

  • LOOK AT US. Chase said doctors need to learn to speak without sounding patronizing, especially when using medical terminology. “If we don’t understand what you are saying, some of us will ask you to explain it in a different way. But not all black people or people of color will speak due to a possible lack of education, language barrier, or nervousness. “
  • LISTEN TO US. Noting the progress of her breast cancer diagnosis after 2 years of forgetting her concerns, Chase said it was because she did not have the typical breast cancer symptoms seen in a white woman. “Therefore, diversity is needed in clinical trials because we do not all have the same symptoms.”
  • BE PRESENT WITH US. Chase stressed the need for doctors to give every patient, regardless of color, their full attention at this time. “We notice their body language and their lack of eye contact. Many of us will feel rushed and not say what we wanted to say. This is a missed opportunity for physicians to build confidence among these diverse populations.
  • BELIEVE US. Chase spoke of the lack of belief about pain, stressing that “not all of us are drug seekers. We want to get to the root of the pain.
  • INCLUDE US. When considering a clinical trial, Chase said patients look to doctors for recommendations and that shouldn’t always be up to the patient to determine. “A lot of us still don’t understand to consider a trial or what that might mean for our quality of life or what you do with our information.”

Bringing the unknown voices of diverse communities heard is at the center of a recent collaboration between the Chase organization GRYT Health and Bristol Myers Squibb, which recently launched a virtual disparity-focused platform called Diversity in Oncology.

With over 281,550 new cases of invasive breast cancer and 49,290 new cases of non-invasive breast cancer believed to affect American women this year, she underscored the need to speak out and include diverse communities to have the hope of improve the health disparities present for people who are forced to experience them on a daily basis.

“Although recognition of health disparities AND action to address them is recent, we are currently witnessing serious and systematic efforts at the highest levels,” she said. “We believe that by having these necessary and courageous conversations on health equity issues and collaborating with those who experience the disparities, we will be able to co-create structural change, together.”

Mental health solutions for breast cancer patients

As health disparities increase in national conversations amid the pandemic, unmet mental health care gaps have also come to light. For breast cancer patients, these issues can often coincide due to the mental and emotional strain caused by diagnosis and subsequent care.

“My initial symptoms before I was officially diagnosed with breast cancer remained unknown for over 2 years. It was 2 years of constantly being fired and I was told I just needed to lose weight and reduce stress, ”Chase said. “When I was finally diagnosed with stage 2A invasive lobular breast cancer in September 2015, I felt validated but also overwhelmed because no one took my symptoms seriously until I felt a thickness in my skin. left breast. “

Fueling feelings of stress, anxiety and depression, the pandemic has increased the emotional burden on breast cancer patients, either those who are newly diagnosed or those who fear a recurrence.

In the management of these mental health problems, emotional support and well-being services, which are vital for survival, are frequently and generally non-existent, unaffordable, inaccessible and / or not part of cancer care for the population. general cancer, noted Betty Sanchez, MSc, MA, lawyer and patient advisor, Blue Note Therapeutics, in an email exchange with AJMC®.

Discussing her experience as a survivor of metastatic breast cancer, Sanchez said she was fortunate enough to have received in-person mental health services on-site from a local non-profit organization that has collaborated with his oncologist and his hospital care system before the pandemic. However, when COVID-19 upset all procedures and elective care, her depression and anxiety, which had been kept at bay, returned.

As seen during the pandemic, the expansion of telehealth has opened up access and opportunities to provide care to millions of patients across the U.S. healthcare system. Specific to breast cancer, in which deferred care could lead to poorer treatment outcomes, Sanchez Blue Note Therapeutics’ organization recently announced a collaboration with Memorial Sloan Kettering Cancer Center to develop an app that provides people living with with cancer care accessible and on demand to treat fear of recurrence.

“Digital therapy for cancer distress following a breast cancer diagnosis – and what follows – can have a significant impact on patient awareness that mental, emotional and health treatment services welfare is important and can be respectfully available and easily accessible, ”said Sanchez.

Noting the potential of digital therapy to remove barriers that contribute to health disparities, such as transportation and access, Sanchez added that the audio teachings and reminders available through the app can provide tailored care to culture, which can help patients learn to think, breathe, relax, reflect on sleep quality, and identify the differences between stressors and anxiety.

“With the introduction of digital prescription therapy to treat the mental health co-morbidities of cancer, providers have the opportunity to meet the needs of the whole person and in the home of their patients,” Blue Note Therapeutics said in a statement. To AJMC®.

Blue Note said its digital drug development includes a diverse set of patient advisers, partners and clinical trials designed to represent all American communities, with particular attention to barriers to equitable access to psycho-care. oncology.

“Our digital therapy provides a tool for managing the distress associated with cancer, while providing the problem-based approaches necessary to envision future medical decisions and ultimately increase overall treatment success. “

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