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Key Considerations for Implementing a Scalp Cooling Program

TON - December 2019, Vol 12, No 6 - Supportive Care
Dia Byrne, MSN, RN, ACNS-BC, OCN
Clinical Nurse Specialist,
St. Luke’s Health System,
Boise, ID

Although chemotherapy-induced alopecia (CIA) is often reversible, in some patients, it can have a negative impact on body image, and lead to increased psycho­social distress and/or decreased quality of life. The severity of CIA depends on several factors, including the type, dose, and schedule of chemotherapy.1

Scalp cooling is one of the few supportive care options available for patients with CIA. Recently, the benefits of this approach were confirmed by additional research that supported the US Food and Drug Administration (FDA)’s expanded clearance of the Paxman and DigniCap scalp cooling systems.2,3

When healthcare providers evaluate whether to implement scalp cooling at their institutions, it is important for them to consider several issues, including safety and efficacy, patient education and advocacy, financial impact, and resources. It is also vital that they review potential barriers to the implementation of these devices to minimize the risk for unforeseen challenges that may negatively affect the patient experience. This article explores several of these considerations with the goal of helping providers make informed decisions.

Manual Cold Caps versus Scalp Cooling Systems

The 2 main approaches to scalp cooling are: (1) commercially available devices (manual cold caps) and (2) cooling systems that are available only to institutions. Manual cold caps, which have not received FDA clearance, require the patient to switch out multiple frozen caps throughout the process. These caps are stored in a biomedical freezer or a cooler filled with dry ice. Scalp cooling systems, on the other hand, are machines that continuously circulate coolant through an attached cap.

Memorial Sloan Kettering Cancer Center, New York, NY, recently implemented a multisite scalp cooling program. Two pathways were developed: (1) a patient-driven program and (2) an organization-driven program. The patient-driven program centered around commercially available cold caps that patients purchased or rented from a vendor and brought with them to the infusion center. The organization-driven program used FDA-cleared scalp cooling machines that were leased and maintained by the institution. In a recent article in the Clinical Journal of Oncology Nursing,4 Fischer-Cartlidge and colleagues described the 2-year process of developing standardized workflows that supported both of these pathways, highlighting many challenges of implementation while acknowledging that best practices are still evolving. Selecting a feasible approach may differ among institutions based on their size, setting, demographics, and funding. As scalp cooling practices evolve and clinics gain more experience, discussions on efficacy, safety, resources, and education will continue.

Efficacy and Safety Issues

Patients purchasing or renting scalp cooling methods that are not cleared by the FDA (cold caps) cause the greatest efficacy and safety concerns. Since extrapolating the efficacy of FDA-cleared cooling machines to commercially available cold caps may be premature, it is difficult to determine whether similar benefits exist between these 2 approaches. Although cold caps have been included in some of the recent research that has been conducted, findings have yet to result in an FDA-cleared device.5,6

The means of temperature regulation is different between cooling machines and cold caps. Cooling machines are connected to the patient’s cap throughout the procedure, which ensures consistent temperature regulation and prevents overcooling. Although there is some question regarding optimal hair follicle temperature to prevent hair loss, a goal of 22°C (71.6°F) is recommended.7 Conversely, because cold caps must be changed during treatment and are stored in a biomedical freezer or a cooler filled with dry ice, they may not maintain a steady temperature and this variability may affect overall efficacy.

In addition, this patient-driven pathway is less desirable because of patient- and environment-related factors. For example, incorrect use of cold caps by patients can result in reduced efficacy or increased risk for thermal injury (eg, frostbite). Compliance with institutional cold application policies and management of dry ice within a healthcare setting can also pose challenges.

Financial Impact

The cost to patients who purchase or rent cold caps can vary depending on the vendor and length of treatment but is estimated to range between $1500 and $3000; usually in installments of $389 to $799 per month. Shipping and dry ice costs may also apply. Although some vendors provide additional patient support and training for free, others may charge an additional fee.8-10 The expense of cooling machines is estimated to range between $1800 and $2200 per patient, depending on length of treatment.11 Unfortunately, most insurance companies do not cover the cost of scalp cooling. As a result, financial disparity issues may arise if an institution cannot provide the service to all appropriate patients free of charge. In small clinic settings, the disparity among patients who can and cannot afford scalp cooling may be more apparent.

Financial toxicity is a multifactorial, complex concept. It is generally defined as adverse economic consequences resulting from medical treatment. Financial toxicity focuses predominantly on the cost of cancer therapies—specifically drug prices—but there are other contributing factors. These may include insurance, nonmedical costs, out-of-pocket (OOP) costs, or lost income related to diagnosis and treatment.12

In a study of financial burden in breast cancer survivors, 25% reported OOP expenses between $500 and $2000; 18% reported OOP expenses between $2000 and $5000; and 17% reported OOP expenses >$5000. Four years after diagnosis, 12% of these survivors reported having medical debt.13 The potential for subjective financial distress (another component of financial toxicity) is associated with poor quality of life.14,15 It is difficult to determine whether the improved quality of life resulting from scalp cooling in some patients may be overshadowed by the financial strain associated with the cost of this treatment. Hopefully, as scalp cooling practices become better defined, advocating for supportive reimbursement models will help to minimize the financial burden for patients.

Resource Challenges

Whereas a patient-driven pathway may present safety concerns, an organization-driven pathway may present increased resource challenges. For institutions that lease cooling machines, there are operational costs to consider. Revenue-related implications may include increased infusion time, which may result in fewer patients being treated in a day. Other expenses may be related to extra staff training as well as day-to-day operations (eg, setup, monitoring, cleaning, and storage of cooling machines).

As discussed in the article by Fischer-Cartlidge and colleagues,4 it is necessary to consider policy development, workflow changes, patient education, scheduling issues, facility charges, and reimbursement structures when implementing a scalp cooling program. Space and power requirements may present challenges, particularly for older buildings. Identifying mechanical and technical support for the machines, including quality checks and coolant storage, is another issue that needs to be addressed. For multisite institutions, the cost of purchasing machines for each location may be prohibitive. Larger facilities or research institutions may be better equipped and financially capable to try new technologies while best practices are still being developed. It is hoped that in the future, vendors will be able to provide more competitive pricing for their products, which may result in a more favorable value analysis for clinics interested in FDA-cleared scalp cooling.

Patient Education

Given the increase in marketing information on scalp cooling devices, as well as increased patient awareness of these options, nurses are charged with ensuring that patients have realistic expectations regarding outcomes. Scalp cooling techniques have demonstrated the ability to limit CIA, but not completely prevent hair loss. Predicting the rate of hair preservation is challenging based on the variability of how success was defined in various clinical trials. In the studies that supported the FDA clearance of scalp cooling systems, treatment success was defined as hair loss of ≤50% and was observed in 59% to 66.3% of patients receiving taxane-based therapy.2,3 Research shows hair preservation is more likely using scalp cooling versus not using scalp cooling but that 30% to 50% of patients still experience moderate hair loss.11 It is critical that nurses understand the current evidence so they can provide quality patient education that supports informed decision-making.

Helping patients understand the entire process—not just the cooling intervention—is important. Although many vendors provide this information, as well as counseling, some patients may be unaware that these resources are available. Many systems outline pre- and postcooling preparations and treatment of the scalp and hair. Before cap placement, the hair is usually wet and may need conditioner. Additional recommendations or components may include specific shampoo and conditioner, hair combing recommendations, hairbrush, towel, and heat exposure guidelines. These “extras” may or may not result in added costs for the patient, and it is unclear whether they affect the efficacy of the scalp cooling intervention.

Conclusion

Scalp cooling implementation requires an evaluation of several factors, including safety and efficacy, financial impact, resource utilization, and patient education issues. Although informal patient pathways, in which patients choose to use their own manual cooling cap system, may still be an option, the lack of manual cold cap efficacy data, stable reimbursement models, and defined clinical practice pathways are logical reasons for some institutions to postpone implementation. All members of the oncology care team play a key role in translating evidence-based practice while supporting patients who may be experiencing distress related to hair loss.

References

  1. Paus R, Haslam IS, Sharov AA, Botchkarev VA. Pathobiology of chemotherapy-induced hair loss. Lancet Oncol. 2013;30:e50-e59.
  2. Nangia J, Wang T, Osborne C, et al. Effect of a scalp cooling device on alopecia in women undergoing chemotherapy for breast cancer. The SCALP randomized clinical trial. JAMA. 2017;317:596-605.
  3. Rugo HS, Klein P, Melin SA, et al. Association between use of a scalp cooling device and alopecia after chemotherapy for breast cancer. JAMA. 2017;317:606-614.
  4. Fischer-Cartlidge E, Ross M, Hernandez K, et al. Scalp cooling: implementation of a program at a multisite organization. Clin J Oncol Nurs. 2018;22:535-541.
  5. Kargar M, Sarvestani RS, Khojasteh HN, Heidari MT. Efficacy of penguin cap as scalp cooling system for prevention of alopecia in patients undergoing chemotherapy. J Adv Nurs. 2011;67:2473-2477.
  6. Lemieux J. Reducing chemotherapy-induced alopecia with scalp cooling. Clin Adv Hematol Oncol. 2012;10:681-682.
  7. Komen MM, Smorenburg CH, van den Hurk CJ, Nortier JW. Factors influencing the effectiveness of scalp cooling in the prevention of chemotherapy-induced alopecia. Oncologist. 2013;18:885-891.
  8. Arctic Cold Caps. Services. https://arcticcoldcaps.com/services/. Accessed April 10, 2019.
  9. Chemo Cold Caps. Pricing. https://chemocoldcaps.com/fees/. Accessed April 10, 2019.
  10. Penguin Cold Caps. https://penguincoldcaps.com/us/. Accessed April 10, 2019.
  11. Paxman. www.paxmanusa.com. Accessed April 10, 2019.
  12. Zafar SY, Peppercorn JM, Schrag D, et al. The financial toxicity of cancer treatment: a pilot study assessing out-of-pocket expenses and the insured cancer patient’s experience. Oncologist. 2013;18:381-390.
  13. Jagsi R, Pottow JA, Griffith KA, et al. Long-term financial burden of breast cancer: experiences of a diverse cohort of survivors identified through population-based registries. J Clin Oncol. 2014;32:1269-1276.
  14. Rosenzweig M, West M, Matthews J, et al. Financial toxicity among women with metastatic breast cancer. Oncol Nurs Forum. 2019;46:83-91.
  15. Spencer J, Reeder-Hayes KE, Pinheiro LC, et al. Short and long term impact of financial toxicity on quality of life in the Carolina Breast Cancer Study. J Clin Oncol. 2017;35(15_Suppl):e18299.
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Last modified: April 27, 2020