Prehabilitation pathways for patients with advanced ovarian cancer - Belfast

Project Title: Prehabilitation pathways for patients with advanced ovarian cancer

Project Lead & Pilot location: Dr Stephen Dobbs, Consultant Gynaecologist & Gynaecological Oncologist Belfast City Hospital – Northern Ireland

Inequality Criteria: Age, minority groups and location

Objective Criteria: Improve survival rates & access to care as well as improve patient experience

Prehabilitation Pathways for Patients with Advanced Ovarian Cancer

Full Case Study (10 minute read)

Outline

Currently, elderly, frail patients may not be considered suitable for standard treatment of surgery + chemotherapy and could be disadvantaged because of this. A dedicated prehabilitation clinic was established in Belfast Trust in 2022 for patients with advanced ovarian cancer in Northern Ireland. The clinic aimed to improve patient fitness before surgery and chemotherapy, ensuring equal access to services.

The programme was specifically designed to identify frailty at an early stage in their local Unit and provide a clear diagnosis and management pathway through the Regional Multi-disciplinary Team Meeting and to improve the overall health of patients prior to and during their treatment (chemotherapy +/- cytoreductive surgery).

The clinic implemented personalised interventions from physiotherapy, nutrition, and psychology. Physiotherapy focused on improving strength and mobility, nutrition optimised dietary plans, and psychology addressed emotional well-being. The objectives were to enhance treatment outcomes, tolerability, and reduce complications, ultimately optimising patients' health and well-being during their treatment journey.

Project Design and Implementation

The Ovarian Cancer Audit Feasibility Pilot demonstrated that older women in Northern Ireland were significantly less likely to receive surgery or chemotherapy as part of their treatment. Among women aged 70-79, 21% did not receive either treatment modality, while among women over 79, the proportion increased to 60%. This highlights a significant disparity in access to appropriate treatment based on age.

The decision to offer primary surgery instead of tissue biopsy and neo-adjuvant chemotherapy in ovarian cancer is based on several factors. First, it depends on the disease burden and the potential for achieving complete cytoreduction, which means removing all visible disease within the abdomen and pelvis (R0 resection). Additionally, the patient's fitness level to undergo extensive cytoreductive surgery is considered. Given the complex and aggressive nature of ovarian cancer debulking surgery, it is crucial that the patient's pre-operative fitness is at a sufficiently high level to withstand the procedure.

If patients are deemed unsuitable for primary cytoreductive surgery due to co-morbidities or the distribution of disease observed on CT scan, they are referred to the medical oncology team. In such cases, consideration is given to neo-adjuvant chemotherapy, which involves administering chemotherapy before surgery. The aim of neo-adjuvant chemotherapy is to reduce tumour size and improve the patient's fitness for subsequent surgery. After completing 3-4 cycles of chemotherapy, delayed cytoreduction may be offered. However, if patients are still considered unfit for delayed cytoreduction after receiving neo-adjuvant chemotherapy, they may proceed with a full course of 6 cycles of chemotherapy without undergoing surgery. This approach is chosen when the patient's overall health or disease characteristics make surgical intervention impractical or risky.

The decision-making process regarding primary surgery, delayed cytoreduction, or chemotherapy-only treatment is guided by a thorough assessment of the patient's disease stage, fitness level, and individual circumstances. The goal is to optimise treatment strategies to achieve the best possible outcomes for patients with ovarian cancer. Furthermore, over a quarter (28%) of ovarian cancers diagnosed each year in the UK are found in women over the age of 75, and two-thirds of these cases present with advanced disease. In Northern Ireland, approximately 80% of ovarian cancer patients come from outside the Belfast Trust, resulting in potential delays in referrals to specialist teams due to capacity issues. This combination of advanced disease and pathway delays, particularly for older women with pre-existing frailty, further diminishes their chances of being eligible for surgery or chemotherapy.

Despite the launch of prehabilitation guidelines by the Department of Health in 2019, Northern Ireland currently lacks a planned, coordinated, and commissioned prehabilitation service. Research has indicated that without prehabilitation and rehabilitation programs, functional recovery is significantly delayed, particularly for older patients. It has been found that six months postoperatively, only 50% of patients have achieved pre-operative functional levels without such interventions.

Implementing a prehabilitation model for patients with advanced ovarian cancer in Northern Ireland can address these challenges and disparities. By providing targeted prehabilitation interventions, such as physiotherapy, nutrition, and psychological support, it is possible to improve patients' fitness levels, enhance their treatment eligibility, and promote better overall outcomes and quality of life.

Data and Measures

Data Collection:

A customised prehab database was developed using MS Access to capture data on measures and interventions. The database, located on a shared drive, was password-protected and accessible to the prehab team. The measures were scheduled to be captured at Baseline (prior to treatment), Mid-chemotherapy, and 1 month post final chemotherapy. Any deviations from the schedule were recorded, including patients who started chemotherapy before baseline prehab or had assessments at different cycles. Information on patients who discontinued prehab due to disease progression, death, or confirmed benign/borderline disease after surgery was also captured.

Rationale for choice of measures:

Measures were selected based on their validity and relevance to the interventions being studied, providing valuable insights into frailty, functional capacity, nutritional status, and psychological well-being. Note that at the baseline face to face prehab visit, patients have a triple screening assessment by the nurse, physio and dietician. These assessments enable an individualised intervention pathway to be assigned to each patient.

The chosen measures for the study included:

The Rockwood Frailty Scale (RFS), 6-minute walk test (6MWT), 30-second Chair to Stand test (30CTS), grip strength, and ECOG performance status for the exercise intervention. RFS assesses frailty on a scale of 1 to 9, while the other measures evaluate functional exercise capacity, lower extremity strength, forearm muscle strength, and overall physical ability.

For the nutritional intervention:

The measures consist of BMI, MUST score, and mid-arm circumference. MUST score identifies malnutrition risk using BMI, unplanned weight loss, and acute illness. Mid-arm circumference serves as an additional indicator of nutritional status.

The psychological intervention:

Involves Holistic Need Assessment (HNA), Distress thermometer, and EQ-5D-5L anxiety/depression score. HNA addresses holistic needs, while the Distress thermometer and EQ-5D-5L measure distress levels and anxiety/depression, respectively.

Additional measures:

These included health-related quality of life assessed using the EuroQol EQ-5D-5L instrument. This instrument evaluates a patient's overall health status across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels indicating the severity of problems. The resulting 5-digit number or single index value reflects the patient's health state compared to the general population. Changes in the index value can measure the impact of interventions. The EQ Visual Analogue Scale (EQ VAS) was also used to measure the patient's self-rated health on a vertical visual scale ranging from 0 (worst health) to 100 (best health).

Results:

Summary:

1. Between February 2022 and January 2023, 76 women with ovarian cancer were referred to the prehabilitation clinic.
2. Of these, 6 patients (8%) had benign or borderline tumours confirmed at surgery and discontinued prehabilitation.
3. The median age of the remaining 70 patients was 69 years. Of these patients 92% had advanced FIGO Stage III or IV disease and high-grade serous histology (89%).

Baseline assessments - Exercise:

• 22% of women had mild or moderate frailty according to the Rockwood frailty score (RFS), while 17% were in the vulnerable group.
• Just over half of the patients (58%) had reduced exercise capacity for their age based on the 6-minute walk test (6MWT), and 25% had considerably reduced exercise capacity (6MWT <250m).
• The combination of RFS and 6MWT determined the pathway for exercise intervention: one-quarter specialised exercise, half targeted exercise, and the remainder in the universal pathway.
• 25% of patients in the universal exercise pathway declined referral to Macmillan Move More, opting for advice on a Home Exercise Programme (HEP) and pedometer use.
• In the targeted exercise pathway, 42% of patients declined referral to virtual exercise coaching.

Uptake of Referrals to Macmillan Support and Information Centre (MSIC) & other support services:

• 42% of women in the universal psychological wellbeing pathway declined referral to counselling services, while 10% in the targeted pathway declined referral.

Nutrition:

The MUST score indicated that 30% of patients were at high risk of malnutrition (specialised pathway), 20% at medium risk (targeted pathway), and 46% at low risk (universal pathway).

Psychological Wellbeing:

• The distress thermometer showed that one-third of patients had moderate distress, and another one-third had severe distress.
• Using the combination of the HNA and distress thermometer, 84% of patients were assigned to the universal psychological intervention pathway, 15% to the targeted pathway, and less than 2% to the specialised pathway.

Outcome Measures

By the time of writing this report, 35 patients had reached the mid-chemo assessment. However, only 18 of them had reached the 1-month post final chemo assessment, which marks the end of the program.

Exercise Intervention (1-month post final chemo, N=18):

• RFS: 31% of patients had an improved RFS, 67% maintained their baseline score, and 1 patient's score deteriorated.
• 6MWT: Two-thirds of patients showed an improvement of at least 14m, considered the minimum clinically important difference. 14% showed no significant change, and 20% had decreased performance.
• 30 sec Chair to Stand Test (30-CST): 79% of patients achieved an increase of 2 repetitions, which is considered the minimal clinically important difference.
• Grip strength: 37% of patients had improved grip strength, 19% maintained their strength, and 44% had reduced grip strength.

Nutritional Intervention (1-month post final chemo, N=18. Use of oral nutritional supplements/food fortification):

• Baseline MUST score patients were at Medium (41%) or High risk of malnutrition (12%): BMI remained stable in 65% of patients, increased in 29%, and decreased in 6%.

Psychological Intervention (1-month post final chemo, N=18):

• Distress levels dropped by 3 or more points on the 10-point scale in 41% of patients.
• EQ-5D-5L Anxiety/Depression scores: 53% of patients had lower scores for anxiety/depression, indicating improved mental health.

Other Prehabilitation Measures:

• Patient-reported Health Score:
  • EQ VAS: 47% of patients reported a 20% or more improvement in their self-rated health.
  • EQ-5D-5L Overall Health State: Almost half (47%) of patients' health index scores improved.

Discussion Points from Pilot Outcomes:

1. Baseline assessment of 70 patients revealed evidence of frailty, reduced exercise capacity, risk of malnutrition, and elevated stress levels in a considerable proportion of women about to undergo major cytoreductive surgery or start chemotherapy for ovarian cancer.
2. The lower-than-expected uptake of exercise referrals, particularly in the targeted pathway, highlights issues related to the acceptability and motivation for prehabilitation in ovarian cancer. Other studies have shown willingness to engage in exercise despite a lack of participation in structured exercise programs.
3. Barriers to engagement in exercise included significant fatigue, abdominal/pelvic pain, ascites, and shortness of breath at baseline assessment. As a response, the protocol was modified to re-offer exercise referrals at the mid-chemotherapy assessment. This raises the question of whether delaying exercise introduction until chemotherapy starts to reduce symptoms may be more appropriate for patients with severe symptoms at diagnosis.
4. Appointment burden and travel times were identified as patient factors, particularly for those living a considerable distance from the centre in Belfast.
5. The results from post-prehabilitation assessments are encouraging, showing improved exercise capacity, physical resilience, and enhanced nutritional and psychological status.
6. The short duration of the project and the tight time frame for this report resulted in a limitation, with only a quarter of the patients' post-prehabilitation assessments available for analysis. To address this limitation, the plan is to capture the results for the full cohort of patients in a supplementary report.

Impact & results

Project successes:

The project achieved several notable successes. Despite a tight timeframe, the team successfully recruited staff, established a clinic, developed a standard operating procedure (SOP), and defined interventions and pathways within six weeks of project approval. The support of senior management and the dedication of the team members played a crucial role in these achievements.

Effective communication and collaboration resulted in seamless integration of prehabilitation into the Multi-disciplinary Team (MDT) and received positive feedback from both patients and staff based in local Units. The medical advisor's efforts in developing a customised database were instrumental in overcoming IT challenges. Furthermore, the project secured support from local councils, enabling access to the Move More Exercise Programme at no additional cost.

The clinic consistently operated well throughout the year, and despite staffing issues, the team managed to ensure continuous service provision by arranging cover. Regular communication and the commitment of the staff were pivotal in maintaining the clinic's functionality.

In a recent milestone, the project obtained recurring funding from commissioners, which was made possible through the support of Improve UK. This achievement paves the way for the continued implementation of the prehabilitation model, ensuring its sustainability and long-term impact.

Lessons learned – challenges and changes:

• Tight deadline for project establishment, requiring adjustments to recruitment timelines, organising appropriate clinic accommodation and equipment acquisition by working alongside supportive senior management.
• Staffing Resilience: We faced challenges in ensuring adequate staffing coverage for the clinic. Initially, three members were recruited without considering leave or sickness cover. When one team member went on long-term sick leave, it placed additional pressure on the remaining staff and impacted clinic capacity. This lack of resilience persisted throughout the project. To address this issue, our evaluation will recommend a return to a prehabilitation model integrated within the service for better resilience.
• Administrative Support: We lacked dedicated administrative staff and had to rely on existing employees to handle administrative tasks. However, issues with sickness and leave led to a lack of cross-cover, requiring the project nurse to take on additional administrative responsibilities. Efforts to find additional cover were not always successful.
• Data collection: Challenges arose in collecting the necessary information for the project. Despite agreeing on a dataset and specific collection points we had to make changes due to difficulties accessing relevant information. For example, the pre-surgery assessment point for patients going directly to surgery was removed in week eight due to logistical challenges with performing the assessment on the day of surgery.
• Patient Experience: Throughout the project, various patient experience factors were identified. As the clinic was regional, patients expressed concerns about travel distance and preferred phone assessments. However, face-to-face appointments were required for project evaluation purposes. We attempted to schedule prehabilitation appointments on the same day as surgical appointments to minimise hospital visits, but this resulted in long and tiring days for patients. While limited changes could be made during the pilot, our future model aims to incorporate virtual dietetic and physiotherapy appointments to address these issues.
• Project Time: Lack of a dedicated project manager and unaccounted hours for the project nurse posed challenges in managing the pilot. Co-leads had to juggle project responsibilities with their existing roles, while additional funding was successfully obtained from Improve UK to cover the nurse's hours and alleviate workload burdens.
• Electronic Holistic Needs Assessment (eHNA) Checklist Completion: Difficulties arose in obtaining completed eHNA checklists from patients before their appointments. This resulted in significant nursing assessment time needed during the clinic visits to complete the eHNA checklist, leading to longer appointments.

Despite these challenges, the project team worked closely, made necessary adjustments, and sought external funding to overcome obstacles. The project continued to progress, with the clinic successfully established and services delivered to patients. The evaluation process will help identify areas for improvement and inform future modifications to address the identified challenges.

Limitations

Despite challenges, the prehabilitation team successfully developed and implemented the service. The short timeframe for establishing the clinic facilitated quick problem-solving and teamwork. Continuity in staff members contributed to better decision-making. Collaboration among various staff groups was crucial, leading to permanent funding for the project. The use of a bespoke database proved invaluable for tracking patient metrics and identifying high-risk groups. Patient involvement played a vital role, with a representative providing input on materials and feedback. Monthly project meetings served as a platform for issue highlighting, decision-making, and service adaptation based on patient feedback.

These lessons learned will guide future improvements and developments in the prehabilitation service for advanced ovarian cancer patients.

Baseline assessment: The baseline assessment of the 70 patients participating in the pilot revealed several important details about their condition. It showed that a considerable proportion of women diagnosed with advanced ovarian cancer exhibited signs of frailty, indicating a decreased ability to perform daily activities independently. Additionally, the assessment highlighted reduced exercise capacity, indicating a lower level of fitness and physical endurance among the patients. The risk of malnutrition was also identified, suggesting potential challenges in maintaining adequate nutritional intake. Furthermore, the assessment indicated elevated stress levels, which could have a significant impact on the emotional well-being of the patients.

Barriers to exercise engagement: The pilot identified various barriers that hindered patients' engagement in exercise programs. Acceptability and motivation issues were prominent factors, suggesting that some patients may have been hesitant or lacked the motivation to participate in structured exercise programs. Fatigue, a common symptom experienced by ovarian cancer patients, was found to be a significant barrier, making it challenging for individuals to engage in physical activity. Abdominal/pelvic pain, ascites (abnormal accumulation of fluid in the abdomen), and shortness of breath were also reported as barriers, indicating the physical limitations faced by some patients. In response to these findings, adjustments were made to the protocol, including offering exercise referral at a later stage of treatment to address these challenges.

Appointment burden and travel times: Patients residing at a considerable distance from the clinic in Belfast encountered difficulties related to appointment burden and travel times. The need to travel long distances for clinic visits added to the burden on patients, potentially leading to increased stress and fatigue. Moreover, the logistics of traveling for appointments may have been challenging, particularly for those with limited mobility or access to transportation. These factors highlighted the importance of considering the geographical accessibility of the prehabilitation program to ensure equitable access for all patients.

Post-prehabilitation assessments: The post-prehabilitation assessments conducted after the completion of the program demonstrated promising outcomes. Patients showed improvements in their exercise capacity, indicating enhanced fitness levels and physical endurance. The assessments also revealed increased physical resilience, suggesting that patients were better equipped to cope with the physical demands of their condition and treatment. Furthermore, the post-prehabilitation assessments showed enhancements in nutritional status, indicating improvements in patients' ability to maintain adequate nutrition. Additionally, positive changes in psychological well-being were observed, suggesting improved emotional and mental health outcomes. However, it is important to note that due to the short duration of the project and time constraints, only a quarter of the patients' post-prehabilitation assessments were available for analysis. To provide a more comprehensive understanding of the outcomes, further analysis of the full cohort of patients is planned in a supplementary report.

Conclusion:

The prehabilitation project for women with advanced ovarian cancer has successfully achieved its aims and objectives. We have developed, set up, and implemented a new service within our MDT to run a prehabilitation clinic that has demonstrated the effectiveness of a personalised combined psychological, exercise and nutritional programme.

A significant observation from the project is that patients referred from outside the cancer centre often experience longer waiting times before receiving care. These patients, upon diagnosis of advanced ovarian cancer, tend to be frailer and may be less suitable candidates for major cytoreductive surgery.

To address this disparity, the project aimed to establish a centralised prehabilitation clinic that offers equal access to all patients, regardless of their referral source. This approach ensures that all patients can benefit from the expertise and services provided by the clinic. By developing a centralised clinic, the project mitigated the impact of delayed referrals and provide timely bespoke interventions to improve patient outcomes.

Project Outputs e.g. protocols, information for patients etc

These outputs contributed to the effectiveness and evaluation of the project.

The project produced several outputs, including:

1. Standard Operating Procedure (SOP): An overview of the program, interventions, measures, and operational details.
2. Information leaflet for patients: Provided to patients at the local unit before referral for treatment, offering information on prehabilitation.
3. Physiotherapy intervention booklet: Given to patients at the clinic along with pedometers and a theraband.
4. Bespoke database: Established to record patient details, assessment information, and facilitate referrals to local exercise coordinators.
5. Patient portal: Tested as an app to provide patients with relevant treatment-related information, still in progress for future implementation.
6. Patient experience survey: Developed and being finalised to support project evaluation.