Prehabilitation Program Aims to Improve Outcomes for Older Patients with Ovarian or Pancreatic Cancer

Frailty and loss of muscle mass are correlated with lower cancer survival in patients 65 and older. Cleveland Clinic Cancer Institute is conducting a clinical trial to demonstrate whether early interventions with prehabilitation can improve outcomes and quality of life for senior patients.

Background

Many older patients with pancreatic or ovarian cancer undergo chemotherapy to shrink their tumor and then proceed to surgery. However, sarcopenia and malnutrition are common among older patients. Deconditioning leads to surgical complications, lengthy recovery times and delays in chemotherapy.

“There is a dire need to help optimize patients’ functional ability prior to surgery,” explains Mariam AlHilli, MD, with Cleveland Clinic Cancer Institute's Subspecialty Care for Women's Health department. “An exercise program and physical therapy can help patients withstand the stressors of surgery and may improve their immunity and ability to fight cancer. Nutrition also plays a major role in patients' recovery and ability to withstand chemotherapy treatment. Yet these interventions are sparsely used in clinical practice.”

This topic has yet to be studied rigorously, so the researchers are evaluating how much prehabilitation can prepare older patients physically, nutritionally and emotionally for surgery and chemotherapy.

“There is a misconception that older patients with these types of cancer are not able to engage in exercise by virtue of their age or disease,” says Dr. AlHilli. “People often think these patients are too sick or debilitated to undergo a prehabilitation program, but that’s not always true. In fact, many have minimal symptoms early on. Sometimes, they’re diagnosed by coincidence, and they do have the strength to tolerate physical therapy and other interventions. Our goal is to gather this data and help change that perception.”

Another key consideration is the psychological benefits of improving a patient's positivity and outlook toward their diagnosis through exercising and engaging with the community.

Study logistics

The researchers are working in collaboration with Cleveland Clinic’s Successful Aging program. When a patient 65 and older is first diagnosed with ovarian or pancreatic cancer, they will be invited to participate in the study. If they decide to do so, a team of geriatricians, dietitians, exercise physiologists, and physical medicine and rehabilitation specialists will conduct a full assessment to gain an understanding of their physical function, nutritional status as well as their emotional well-being. Interventional supports offered as a result of the assessment include:

Physical therapy. Patients will work with an exercise physiologist at the Langston Hughes Community Health & Education Center to help them improve functionality prior to surgery. The physiologist will guide them in strength training, and will track their progress.

Nutrition support. Appetite loss and the inability to take in enough nutrition are common for older patients with cancer. Nutritional supplements, as well as personal guidance, are provided to ensure the patient is receiving proper nutrients.

Psychosocial support. Patients facing cancer often have many psychosocial needs. Through the program, patients have access to social workers who can help with issues such as anxiety and depression. Patients may also visit the Taussig Cancer Center for support services such as one-on-one mentoring, yoga, reiki and meditation.

Palliative care. People often mistakenly believe palliative care is only provided at end of life, but these services are beneficial at any time in a patient's cancer journey to provide symptom management, care coordination, support with decision-making, and spiritual care.

As part of the study, Cleveland Clinic is providing patients with complimentary transportation to and from prehabilitation appointments.

Supporting clinical trial equity

The study is part of Cleveland Clinic Cancer Institute’s efforts to improve the equity of clinical trials. Older patients are one population that is often left out of clinical trials, and the organization is working to change that.

“A significant number of patients with cancer are elderly, but oftentimes they're not included in clinical trials because they're thought not to be ideal candidates,” says Dr. AlHilli. “But age should not be the determinant of whether a patient is a candidate for a trial or not and whether they'll benefit from a treatment, as there is a great deal of variability in how an older patient is functioning. Many trials tend to focus on optimizing endpoints of studies by including ‘ideal’ patients, but it's better to include a general pool of patients so we can really apply the results to the real world."

Next steps

The initial plan is to enroll roughly 120 patients in the study. The researchers anticipate that they will see meaningful improvements in physical strength and improvements in patients’ quality of life. During the study, they aim to assess whether they can achieve the following goals:

• Improving functional outcomes by 60% (measured during a six-minute walk test and grip strength tests)
• Reducing the rate of postoperative complications, length of hospital stays and time to return to post-operative chemotherapy by 40%
• Improving quality of life scores between baseline and end of study by 20%

If the researchers are able to demonstrate improvements in patients’ quality and life and outcomes, the plan is to conduct a larger trial. The hope is that with this data, prehabilitation will be adopted more routinely in practice, and that these interventions will be covered by insurance.