JPM | Free Full-Text | Preventing Bone Loss in Breast Cancer Patients: Designing a Personalized Clinical Pathway in a Large-Volume Research Hospital

By inergency On Mar 30, 2024

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3.1. Analysis and Planning

In our previous model (Figure 1), post-surgery BC patients were discussed by a multidisciplinary tumor board, and those with hormone-receptor-positive tumors received indications to start adjuvant endocrine therapy. These patients continued their clinical course in one or more medical departments (Medical Oncology, Gynecological Oncology, Breast Pathology, and Medical Radiology). Some of them were referred to our outpatient clinic specialized in menopause and osteoporosis for a basal evaluation of bone status, including Dual-Energy X-ray Absorptiometry (DXA) of the lumbar spine and the hip and a panel of bone metabolism blood tests, followed by the prescription of antiresorptive treatment, if appropriate.

Patients underwent annual follow-ups with hip and spine DXA and a serum bone metabolism profile until endocrine therapy ended. A final follow-up was scheduled at the end of the AI treatment. The rest of the patients (not referred to our menopause and osteoporosis outpatient clinic) were referred to different bone health centers nearby or within our hospital.

In analyzing the previous pathway, several critical points and unmet needs were identified. Initially, there was a mismatch between different specialists due to different working hours and organization. The resulting delay in evaluation led to inconsistencies in the treatments prescribed (patients were disoriented by the different professionals approaching the problem).

Regarding the patient’s taking charge phase, the presence of a tumor board that defines treatment strategies for each patient represented a key asset. Limitations consist of the absence of defined criteria for the distribution of patients between professionals and departments. We, therefore, understood that criteria should be defined and a bone specialist (e.g., gynecologist, rheumatologist, orthopedic, or endocrinologist) should be identified and involved as early as the tumor board stage so that the bone health pathway could be defined at the same time as the therapeutic strategy.

Another limitation of this phase consisted of the lack of implementation of a structured bone pathway, which assesses bone status and treats it according to current shared guidelines, at the time of the prescription of endocrine treatment during the tumor board review.

During the basal assessment phase, the presence of an outpatient clinic for menopause and osteoporosis within the hospital represented a strength. On the other hand, limitations consisted of the lack of dedicated slots for the required diagnostic examinations and the absence of shared assessment criteria for patients’ bone status at the baseline. We also found discrepancies in the timing of patient assessment between different professionals, while the absence of a key case manager in such a pathway represented a major weakness.

In the treatment phase, a strength was noted regarding the involvement of the family physician in prescribing denosumab after receiving the treatment plan from the specialist. It was also noted that patients were educated to adopt a correct lifestyle, eat healthily, and perform physical activity. Limitations included the lack of a multidisciplinary team in prescribing treatment and the absence of the implementation of Note 79.

In 2021, n. 643 patients with a new diagnosis of BC were discussed in our multidisciplinary tumor board reviews, 34% (n. 222/643 patients) of whom underwent DXA evaluation within 30 days (Figure 2A). Only 14% (n. 93/643 patients) were prescribed antiresorptive therapies within 90 days (Figure 2B).

Regarding the follow-up phase, DXA and serum profiles of bone metabolism markers were performed annually, and if there was any change in bone status, the patient was referred to our menopause and osteoporosis outpatient clinic or to the oncologist; even in this case, we pointed out the lack of a case manager to coordinate the bone health pathway. Another limitation was the discrepancy among oncologists regarding the application of eligibility criteria for Note 79 and the timing of bone health assessment.

Additionally, some unmet needs were identified, including the lack of shared criteria between departments for evaluating whether to continue or not treatment after the end of adjuvant endocrine therapy. The lack of referring patients to dedicated bone specialists and the absence of structured protocols for other hospital specialists were noted. The need for a case manager to support the bone health pathway (e.g., filling out the treatment plan, helping manage the follow-up phase, and contributing to patient education) remained a primary issue.

Considering all these challenges, the design of a new personalized clinical pathway seemed the most appropriate organizational choice. This analysis created an opportunity to generate a defined workflow that promotes specialists’ training in and awareness of defining activities, responsibilities, and timelines focused on the proper implementation of therapeutic choices.

3.2. Action and Monitoring

As we understood there was a need for implementing a novel pathway to systematically treat patients in a more personalized manner, we also set the goal of substantially reducing BMD assessment to within 30 days and therapy prescription to within 90 days. Such a project required the introduction of the following organizational changes:

Alignment between the professionals and the design of a dedicated, transversal bone health pathway to be applied for all BC patients undergoing hormonal adjuvant therapies, in line with Note 79 (regarding the correct therapy definition) for personalized patient management and care.
Identification and integration of a bone specialist from the tumor board phase, to define every therapeutic strategy for each patient and evaluate the treatment of bone loss.
Introduction of a case manager (nurse) as a pivotal figure for interprofessional coordination, supporting therapy prescription and follow-up, as well as patient education.
Training the health professionals and administrative staff involved in activity ownership and timing, to select the best care treatment and facilitate the organizational workflow.

We designed a Diagnostic Therapeutic Assistance Pathway (DTAP) that fully implements international and local guidelines after the verification of correct therapies, along with a structured bone health treatment pathway for patients (Figure 3). The pathway includes a worktable with defined criteria presenting the treatment guidelines, to update the participating specialists. It was designed according to the value-based healthcare model, a patient-centered transversal approach to organizational processes [34].

During the tumor board review, a multidisciplinary team consisting of gynecologists, breast specialists, radiologists, and oncologists follows a shared protocol that defines the diagnostic procedures required for the basal assessment of bone health, the timing of these assessments, and the criteria for interpreting the diagnostic results. For each case discussion, if a decision is made to prescribe adjuvant endocrine treatment, the bone health pathway is activated by the case manager (in our organization, this is a nurse). Patients’ information is inserted into a computerized database for registration. The case manager then creates an Excel file containing the patient’s details and email addresses. Prior to each stage of the pathway, patients are contacted via phone and receive a comprehensive email including communications that outline the upcoming steps and provide clarity on their role in the procedure. The case manager verifies, for every BC patient who is a candidate for adjuvant endocrine treatment, whether she has been evaluated by a bone specialist (in our organization, this is a gynecologist):

(a): If the patient has not been evaluated, the case manager schedules an appointment within 30 days of the prescription of adjuvant endocrine treatment.
(b): If the evaluation is already present, the case manager assesses whether the examinations are recent and have them repeated if necessary.
(c): If no such evaluation is present, the case manager prescribes DXA of the spine and femur and a blood panel for bone metabolism assessment.

Once the patient has completed the tests, the case manager schedules a meeting at our menopause and osteoporosis outpatient clinic, where the patient is evaluated by the bone specialist.

This evaluation and eventual treatment take place within 90 days of the start of adjuvant endocrine treatment. The bone specialist evaluates diagnostic tests and, taking into account the patient’s personal history, risk factors, Note 79, and other medical guidelines, prescribes antiresorptive treatment, and, if appropriate, vitamin D and calcium supplementation. Bone health status is monitored by DXA and blood tests throughout the duration of adjuvant endocrine treatment.

At the end of the BC therapy, further assessment of bone health is conducted to decide whether antiresorptive therapy should be continued, modified, or suspended. In the case of vitamin D supplementation alone following normal BMD, the patient will continue annual follow-ups to monitor any decline in BMD status. After this evaluation, patients continue to follow-up if needed. In this scenario, we monitored the first year of the new DTAP (Figure 4A–D).

From July 2022 to June 2023, n. 915 patients were discussed in our multidisciplinary tumor board for breast cancer, 60% (n. 548/915 patients) of which underwent DXA evaluation within 30 days, and 39.5% (n. 361/915 patients) were prescribed antiresorptive therapies within 90 days, thus increasing patients’ compliance. The mean age of the patients was 53.2 years old, and the mean BMI was 23.7. Forty-eight percent of the patients were treated by chemotherapy, while 71.5% underwent radiotherapy. All patients received the standard therapy for the stage of disease with AI with or without ovarian suppression, depending on menopausal status.

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