The New Year Brings Important Policy Changes That Benefit Patients

January 13, 2020

As we start a new year, the Cancer Support Community (CSC) is pleased to report on two exciting policy changes that promote the delivery of psychosocial care for cancer patients.

Patient Experience and Psychosocial Care

The social and emotional impact of cancer (together known as the psychosocial impact) is well known to patients and their families. It is vital that the patient experience, including the psychosocial impact of cancer, is understood, considered, and made an integral part of comprehensive cancer care. As discussed below, significant strides have been achieved to make sure that psychosocial screening and care are included in the standard of comprehensive cancer care.

A groundbreaking 2008 report from the Institute of Medicine (IOM), Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs, stated that comprehensive cancer care must include psychosocial care (such as screening patient distress and providing follow-up care). Today, the IOM, the Patient-Centered Outcomes Research Institute (PCORI), the American College of Surgeons Commission on Cancer (CoC), the American Society of Clinical Oncology (ASCO), and the Community Oncology Alliance (COA) all recognize psychosocial care as the standard of care in oncology.

In 2017, the FDA Reauthorization Act expanded the definition of “patient experience data” to include not only the physical impacts of a condition, therapy, or clinical investigation/trial, but also its psychosocial impact. This Act was groundbreaking, as it was the first time Congress fully recognized that psychological well-being must be considered as equally important to a patient’s physical well-being in clinical research.

While these advances are significant, more remains to be done so that all cancer patients get the full benefit of psychosocial care.

Government Funding Bill includes Language on Psychosocial Distress Complications

In the last days of December 2019, the Senate passed the fiscal year 2020 domestic appropriations package in order to fund the federal government. The bill included a specific provision, championed by Senator Jon Tester (D-MT), encouraging the National Cancer Institute (NCI) “to ensure that all of its designated cancer centers are managing and measuring patients for distress as an integral piece of their treatment and follow-up care.”

This language means that, as drugs and devices are used to treat or monitor people living with cancer, health care providers at NCI designated cancer centers as well as research that occurs on NIH’s own campus will be asked to capture not only the physical impacts, but also the social and emotional issues that impact the patient’s treatment and follow-up care.

CSC is grateful to Senator Tester for championing the specific inclusion of this provision within the bill and to Cancer Support Community Montana for their advocacy efforts.

“Everyone who has been affected by cancer knows the toll it takes on patients not just physically, but emotionally as well," said Senator Tester. "This funding will help us better understand the mental health effects of a cancer diagnosis and support patients who are participating in clinical trials—leading to improved outcomes for folks fighting cancer.”

The FDA and the Importance of Psychosocial Status in Clinical Trials

Dr. Stephen Hahn, a radiation oncologist who specializes in the treatment of lung cancer and sarcoma, was confirmed as the new Commissioner of the FDA in December 2019. During his confirmation hearing, Senator Tammy Baldwin (D-WI) asked Dr. Hahn for his perspective on including the assessment of a patient’s psychosocial status in clinical trials in order to achieve a better understanding of the patient experience.  Senator Baldwin also asked how Dr. Hahn  would work to ensure that the FDA works with pharmaceutical manufacturers to include comprehensive and reliable measures on patient experiences that capture physical and psychosocial symptoms in clinical trials.

Dr. Hahn said he recognized “the importance of patient psychosocial status assessment in clinical care and research” and stated that he “is committed to implement the requirements of 21st Century Cures and FDARA as well as work with FDA staff to determine additional steps that can be taken to advance patient-focused drug development. 

CSC is grateful to Gilda’s Club Madison for their advocacy efforts with Sen. Baldwin over the last several years.

CSC commends Dr. Hahn’s recognition of the importance of assessing a patient psychosocial status in clinical care and research, as well as his commitment to advancing patient-focused drug development.

What are the Next Steps?

These policy changes are important building blocks in ensuring that psychosocial care is included in the standard of care and clinical research in oncology. We also believe it is important to measure the potential psychosocial impact of a certain therapeutic intervention and will be working with the FDA to ensure that such data is collected as part of a clinical trial. We believe patients not only deserve appropriate psychosocial care in all clinical settings but also that clinical research should adequately and equitably capture the social and emotional impacts of a given treatment.

Please join CSC is advocating for change for cancer patients and for comprehensive, high-quality cancer care by joining our Grassroots Network. It is a place where you can go to stay up-to-date and learn more about key issues that are important to patients with cancer and their loved ones and also a place where you can make your voice heard at the local and national level.


Institute of Medicine, Committee on Psychosocial Services to Cancer Patients/Families in a Community Setting. Cancer care for the whole patient: meeting psychosocial health needs. Washington, DC: The National Academies Press, 2008.