New Research Focuses on Breast Cancer Treatments and Quality of Life

Breast cancer and the treatments used to care for patients are often associated with adverse physical, psychosocial and mental health effects. The Maroone Cancer Center at Cleveland Clinic Florida is conducting a number of investigator-initiated research studies looking specifically at health-related quality of life (HRQoL) issues experienced by patients during and after treatment for breast cancer.

“A lot of time is invested in research to improve treatment outcomes for patients with breast and other forms of cancer, and rightly so,” says Elizabeth Stone, MD, a board-certified medical oncologist with Cleveland Clinic Florida. “But these treatments can also have significant impacts on our patients’ quality of life, and as physicians, we need to work to minimize those impacts. That is the goal of our research.”

Weight loss interventions

Obesity is associated with an increased risk of breast cancer recurrence and poorer survival outcomes.

It is also negatively related to quality of life in breast cancer survivors. Investigators at Cleveland Clinic Florida, led by Dr. Stone, are nearing accrual for a 50-patient weight loss study to determine if moderate diet and exercise interventions, under the direction of a nutritionist, can improve aspects of quality of life in patients with early-stage breast cancer.

“Research has shown that losing 5 to 10% of body weight can impact cancer recurrence in patients who are overweight or obese,” says Dr. Stone, noting that these studies usually involve intensive weight management programs. “We are looking at how less intense interventions can impact both weight and patient-reported quality of life outcomes.”

In addition to tracking weight and BMI at baseline, 3 and 6 months during active treatment, study participants also complete a standard Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire that measures five domains of HRQoL: physical, social, emotional, functional well-being and breast cancer-related issues, such as body image and hair loss concerns, among others.

Art and music therapy

Psychological and emotional distress experienced by patients at the time of a cancer diagnosis continues to affect quality of life throughout treatment and well into survivorship. In another study, Cleveland Clinic Florida researchers are investigating the use of art and music therapy to optimize a patient’s psychosocial adjustment and quality of life during active treatment for breast cancer.

Zeina Nahleh, MD, FACP, Cleveland Clinic Florida’s Regional Institute Chair for Cancer and Director of the Maroone Cancer Center, is principal investigator for the recently launched trial that will enroll 72 patients with early-stage breast cancer. After being randomly assigned to either art therapy, music therapy or standard care, participants in art and music therapy will attend in-person or virtual sessions every two weeks for 12 weeks, including two group sessions.

“Previous work by our team has suggested a beneficial effect of art therapy on reducing pain and distress for patients with cancer,” Dr. Nahleh says. “Our goal is to build on this promising work by conducting a randomized controlled trial to study the effects of art therapy and music therapy on improving quality of life, cognitive function, depression and anxiety.”

The outcome of the research will be based on patient self-reporting using scientifically validated questions, before and after the sessions. In addition to the FACT-B questionnaire, the 7-item anxiety scale (GAD-7) will screen for generalized anxiety disorder (GAD) and assess severity, and the PHQ9 (patient health questionnaire) will measure for depression and severity. Cancer-related cognitive impairment, experienced by many cancer survivors, also will be tracked using the FACT-Cognition tool.

According to Dr. Nahleh, the unique design of this trial demonstrates a decentralized clinical trial model that encompasses Cleveland Clinic Florida’s three cancer centers across southeast Florida.

“Patients can participate in interventions and electronically submit their patient-reported outcomes from the comfort of their homes, which is a new and truly patient-centric research design,” describes Dr. Nahleh. “We are leading the way in ‘virtual’ clinical trials, which is going to provide more flexibility to research participants and revolutionize how trials are conducted in the future.”

Vitamin B12 for joint pain

In a third study, to be launched later this year, the Maroone Cancer Center will enroll up to 150 patients in a phase 3 trial that compares the effect of vitamin B12 to standard of care for the treatment of aromatase inhibitors associated musculoskeletal symptoms (AIMSS) in patients with stage I-III breast cancer.

“AI-associated joint pain is an often cited cause of treatment noncompliance,” explains Dr. Nahleh, who also serves as principal investigator for this study. “Data from previous studies suggest vitamin B12 may have a potential role in reducing pain and possibly improving the quality of life for patients taking aromatase inhibitors, which we hope to confirm with this study.”

In addition to obtaining patient-reported outcomes using the brief pain inventory (BPI-SF), the study will use the FACT-Endocrine Symptoms questionnaire to track other QOL-related symptoms, including hot flashes, loss of sexual interest, vaginal dryness, and weight gain.

“Cleveland Clinic Florida is dedicated to pursuing innovative protocols to support patients during their cancer journey,” says Dr. Stone. “We hope that results from these studies will help focus efforts on integrating evidence-based modalities to reduce the burden of cancer treatments and help patients transition optimally to life after cancer.”