There’s no question cancer care is expensive, so much so that it becomes financially “toxic” to many patients and their families, forcing them into bankruptcy, even bringing on early death when treatments, drugs or services are abandoned due to skyrocketing costs and staggering debt.
A new collaboration between Fred Hutchinson Cancer Research Center and the SWOG Cancer Research Network will road-test a program designed to curb financial toxicity before it can do this kind of harm. The intervention will give cancer patients access to proactive financial counseling and financial navigators as part of their treatment plan. They’ll also get resources to help with co-pays and nontreatment-related costs like transportation.
“There’s an abundance of literature showing that cancer care bills are too high. That’s a well-known fact,” said Dr. Veena Shankaran, principal investigator of the study and the co-director of the Hutchinson Institute for Cancer Outcomes Research. HICOR serves as a neutral provider of health economics science, providing the data to guide policy change.
“We’re focusing on things we can do to lessen financial hardship,” she said. “There’s an urgent need for interventions that address cancer patients’ and their spouses’ financial concerns.”
Shankaran said findings from the SWOG-run study could pave the way for the inclusion of financial navigation as an essential component of high-quality cancer care.
“It’s hard for clinics to justify investing in these services unless we can prove it actually helps people do better,” she said. “And the strongest way to do that is with a randomized study design.”
The five-year, multi-institutional trial, powered by a $3 million National Institutes of Health grant, will make use of the National Cancer Institute’s Community Oncology Research Program, or NCORP, and its 900-plus cancer clinics, as well as two financial nonprofits: the consumer financial counseling CENTS Program and the Patient Advocate Foundation, home to cash grants and financial navigation services.
The research team will recruit, randomize and follow 536 patient-and-caregiver “research dyads” from within the NCORP system to see if a proactive intervention can reduce the hardship and stress brought on by cancer and its financial collateral damage.
“We thought dyads were the best way to study household impact,” Shankaran said. “Also, when we involve caregivers, patients are much more engaged in the intervention.”
HICOR’s research has shown all patients — regardless of insurance type or socioeconomic status — are vulnerable to cancer’s financial burden and bite. And the symptoms are severe: debt, bankruptcy, financial worry, even cessation of treatment, which often leads to death. Patients who are overwhelmed with financial burden early in the course of their disease may also require more intense hospital-based care later, particularly at the end of life.
This intervention aims to nip all that in the bud.
The idea is to offer financial literacy training and financial navigation services (complete with grants for pharmacy co-pays) to see if this kind of practical, proactive help up front can keep cancer patients and their caregivers from being overburdened.
In previous pilot studies, HICOR researchers found that “substantial financial assistance” with out-of-pocket expenses made it possible for patients to actually afford their medications and continue with their treatment. Not surprisingly, they also worried less.
Now, the researchers will see if these programs lead to better quality of life, less hardship and fewer emergency room visits and hospitalizations with all the accompanying costs and caregiver burden.
Shankaran and the SWOG study team, including Dr. Dawn Hershman of Columbia University, Dr. Ruth Carlos of the University of Michigan, Dr. Shelby Langer of Arizona State University and Drs. Scott Ramsey and Joe Unger of Fred Hutch, hope to start recruitment in the fall, COVID-19 willing.
Their targets: cancer patients and their caregivers, regardless of preexisting financial status. This study follows earlier work, also led by Shankaran, which was the first in the NCI’s National Clinical Trials Network to look at financial toxicity. Results of that research, which examined the extent of the problem, will be announced at ASCO; this new study is testing solutions.
“We’re asking couples, ‘How likely is it for you to come up with $2,000 in 30 days?’ as a sort of qualifying question,” Shankaran said. “We’re stratifying based on this, but it’s not a requirement for inclusion. We’re trying to understand if the intervention works differently in people who do versus those who do not have these resources.”
The study is open to those with all cancer types — solid tumors as well as blood cancers — but only patients (and partners) dealing with metastatic or advanced disease are eligible. Both English and Spanish-speaking patients are sought, along with others who are medically underserved (think people of color, rural populations, etc.).
“We wanted to be inclusive of all cancers and get the people who are struggling the most,” she said. “Previous studies have shown us things are different for people dealing with metastatic disease. They have a lot more appointments, a lot more treatments. Metastatic disease requires much more care from the caregiver. And there’s no clear endpoint.”
Recruitment will be conducted through many of the same clinics within the NCORP system that participated in previous HICOR studies, with patients and their caregivers randomized into a control and an intervention arm.
At study start, participants in both arms will review a basic education video on financial concepts relevant to cancer care costs. After that, the control arm’s work will be done, while the intervention arm will just be rolling up its sleeve.
In this group, participants will be assigned a financial counselor from CENTS and a financial navigator from the Patient Advocate Foundation, or PAF, that they’ll connect with once a month for six months. Bilingual financial counselors, navigators and study materials will be available for Spanish speakers.
“The first session will always be by phone or videoconferencing,” said Shankaran. “Then they’ll be contacted monthly for six months, with each session as long as it needs to be.”
In each interaction, the financial experts will go through a checklist. If the patient’s household has no issues, it’s a short meeting. If they have lots of issues, they’ll be provided with the tools, training and resources to tackle what they can.
The financial counselors will mostly help with the big-picture view, Shankaran said. Think budget planning, financial planning, retirement, disability and employment issues. Financial navigators will tackle more immediate, practical concerns.
“They’ll be able to help with out-of-pocket costs and nonmedical expenses, providing small grants and actual resources,” she said. “They can also liaison with insurance companies.”
Help will be tailored to each household’s needs, so some people will likely need more of one service than the other.
“People who are less well-off financially, people without insurance or without good insurance, they’re going to need the resources,” she said. “There’s nothing to counsel about it if you have no money or savings.”
Participants will be surveyed before, during and after the intervention regarding their quality of life, financial stress, financial anxiety, caregiver burden and adherence to medications. Researchers will also track each patient’s hospital and ER use and review the credit reports of both patients and their partners, weighing and analyzing all data from both arms to see what the science says.
“The hypothesis is that patients may have less hospital and ER use, better access to therapies and that caregivers will be less burdened,” Shankaran said. “But this will be a five-year study and it will take a while for us to really understand the impact.”
One potential impact: more practical financial help for patients.
“Some clinics have financial navigators and counselors, but they’re not robust and they’re not consistent,” she said. “If we can prove it actually helps people do better, then I think this will have policy implications.”
But those policy changes may be much broader than emergency grants and help with financial planning.
“It goes beyond just having a navigator and counselor at every clinic,” she said. “Why do we even need them? Can’t we do better? If we show the system is so broken that people need all of this assistance just to get appropriate cancer care, shouldn’t we change the system?”
Diane Mapes is a staff writer at Fred Hutchinson Cancer Center. She has written extensively about health issues for NBC News, TODAY, CNN, MSN, Seattle Magazine and other publications. A breast cancer survivor, she blogs at doublewhammied.com and tweets @double_whammied. Email her at firstname.lastname@example.org. Just diagnosed and need information and resources? Visit our Patient Care page.