Clinical Meaningfulness: Insights from a Metastatic Breast Cancer Qualitative Study

Although no curative treatment exists for metastatic breast cancer, advances in care options have significantly improved the long-term survival rate of patients. The disease now has a median survival rate of 3 years, albeit this figure is subject to disease subtype, patient characteristics, and access to healthcare services. Perhaps more importantly, treatment discussions for metastatic breast cancer continue to be informed by patient values, preferences, and care goals, as the importance of clinical meaningfulness is increasingly recognized by cancer care teams in the United States. 

Clinical meaningfulness involves ensuring treatment outcomes are relevant to what patients consider important (ie, quality of life and survival). However, it is defined differently among providers, patients, and caregivers. While some consider survival length important (eg, 6 months to 2 years), others highlight the importance of progression-free survival time and life events such as birthdays and holidays as meaningful for their cancer care journey. Clinical meaningfulness may also change over time and requires continued reassessment of what matters most to the patient.

In the context of metastatic breast cancer, clinical meaningfulness involves interventions that not only extend survival but also enhance the overall well-being of patients. This includes therapies that effectively control the progression of the disease, alleviate symptoms, minimize treatment side effects, and/or allow patients to maintain a good quality of life, for as long as possible. To ensure clinical meaningfulness, it is imperative for providers to engage patients and other key stakeholders throughout the cancer care journey.

“Clinical meaningfulness in metastatic breast cancer care must consider the individual patient’s goals, preferences, and values. Care teams need to consider multiple factors including treatment tolerability, impact on physical and emotional health, ability to maintain relationships and engage in meaningful activities, as well as overall satisfaction with care.” -Molly Kisiel, MSN, FNP-BC, Director Clinical Content, ACCC

Phase 1: Qualitative Research Study

To further explore clinical meaningfulness in comprehensive care delivery for patients with metastatic breast cancer, the Association of Cancer Care Centers (ACCC)—in partnership with the Academy of Oncology Nurses and Patient Navigators (AONN) and the Advanced Practitioner Society for Hematology and Oncology (APSHO)—participated in a multi-stakeholder collaboration with Gilead Sciences, PRECISIONheor, and Brown University to conduct a study assessing stakeholder perspectives on clinical meaningfulness and clinically meaningful outcomes in metastatic breast cancer. Patient advocacy partners included: Living Beyond Breast Cancer; Sharsheret; Touch, the Black Breast Cancer Alliance; and Dr. Susan Love Foundation for Breast Cancer Research.

The qualitative semi-structured study aimed to identify how these concepts are operationalized within current oncology clinical practice.

Study objectives included:

• Examining perspectives on clinical meaningfulness and clinically meaningful outcomes associated with metastatic breast cancer treatment
• Identifying how clinically meaningful outcomes are incorporated into treatment discussions in the clinical practice setting.

Study participant demographics included people living with metastatic breast cancer, caregivers, and providers (ie, oncologists, advanced practice providers [APPs], and oncology nurses). Twenty-two focus groups were conducted with 50 patients, 24 caregivers, 8 oncologists, 13 APPs, and 17 oncology nurses between March and June 2023 across 24 states in the US.

Study Findings

Results showed a lack of awareness among patients and caregivers on the concepts of clinical meaningfulness and clinically meaningful outcomes. Providers reported awareness of these concepts, but noted they were not used in discussions with patients on treatment recommendations. Regarding the definition of clinical meaningfulness, while some providers described it as quantitative endpoints (eg, additional months of survival, progression-free survival), participants across all groups described clinically meaningful outcomes predominantly as patients’ abilities to achieve life goals. Additionally, across all stakeholders, participants stressed that outcomes considered meaningful are highly individualized and dynamic, evolving over time as patients move through the care continuum and their life stages.

The study revealed the following recommendations:

• Providers should employ accessible and patient-friendly terminology in treatment decision-making discussions.
• Providers should take a patient centered approach during treatment decision-making discussions, with inclusive, dynamic patient-provider conversations and continuous evaluation of patient priorities across the care continuum, not just at diagnosis.
• Outcomes should be examined beyond overall survival to be considered meaningful. Other important factors include quality of life, progression-free survival, minimal or manageable side effects, and improvement in symptom burden and daily functioning.

Ensuring clinically meaningful outcomes should be the primary focus for both the care team and patients when making treatment decisions, particularly in the challenging scenario of metastatic breast cancer. It is essential to continually reassess this aspect throughout the treatment journey. Meaningful dialogues with patients and their caregivers should be integrated into the treatment plan to gauge whether adjustments are necessary based on evolving treatment goals.

Consequently, providers should actively involve the entire care team in shared decision-making processes, as patients may occasionally feel more comfortable discussing their evolving goals with other team members. In the context of ACCC members, the pursuit of clinical meaningful outcomes holds significant importance, particularly concerning patient navigation, managing financial burdens, and prioritizing quality of life for cancer patients.

Phase 2: Quantitative Survey Study

While the Phase 1 study has concluded, this important work continues. In March 2024, ACCC will collaborate with its partners on a Phase 2 Quantitative Survey to assess patient, caregiver, and oncology provider perspectives on clinical meaningfulness and novel treatments, while identifying issues of concern among stakeholders related to the treatment of metastatic breast cancer. Objectives for Phase 2 include quantifying how perspectives and opinions of stakeholders may vary by clinical and demographic characteristics, how attitudes and beliefs of providers may vary by demographic and practice characteristics, and analyzing the role oncology clinicians play in treatment decision-making and supportive care for patients with metastatic breast cancer.

For more information on the quantitative phase of this study, contact ACCC’s Provider Education Department.

References

1. Graff, S., Freeman, E., Roach, M., Wilson, R., Stemland, J., Chan, B., Katz, J., May, S. Patient-Centered Collaborative Research: Exploring Perspectives on Clinical Meaningfulness in Metastatic Breast Cancer with Clinicians, Patients, and Caregivers. JCO Oncol Prac 19, 2023, suppl 11; abstr 338
2. Graff, S. Freeman, E., Roach, M., Wilson, R., Fairley, R., Gullatte, M., Stemland, J., Chan, B., Wochal, P., Katz, J., and May, S. Understanding Clinical Meaningfulness in Metastatic Breast Cancer Treatment-Decision Making: Experiences and Perspectives of Patients, Caregivers, and Clinicians. 2023 December 6, 2023. San Antonio Breast Cancer Symposium abstract PO1-10-06

This program was made possible by support from PRECISIONheor.

This study is sponsored and funded by Gilead Sciences, Inc.