Dr. Tracy Crane Co-leads PCORI Study on Lifestyle Interventions in Older Cancer Survivors

As the co-principal investigator, Dr. Crane is approved to receive funds from the Patient-Centered Outcomes Research Institute (PCORI) for a study on lifestyle interventions in older cancer survivors and caregivers.

Tracy E. Crane, Ph.D., RDN, co-lead of the cancer control research program and director of lifestyle medicine, prevention and digital health at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, is co-principal investigator of a study on how diet and exercise impact mental and physical functioning in older cancer survivors and their caregivers.

Together, Dr. Crane and Christina Dieli-Conwright, Ph.D., M.P.H., exercise oncology and population sciences researcher at Dana-Farber Cancer Institute and associate professor of medicine at Harvard Medical School, are approved to receive a total of $7 million in funding for their study from the Patient-Centered Outcomes Research Institute (PCORI), a Washington, D.C.-based nonprofit organization that supports research designed to help patients, caregivers and clinicians make better-informed health care decisions.

“This study was selected for our funding for its potential to answer the need for real-world comparative clinical effectiveness research across the aging continuum that could inform evidence-based clinical practice for this important population,” said PCORI Executive Director Nakela L. Cook, M.D., M.P.H. “We look forward to following the study’s progress and working with Sylvester and Dana-Farber to share the results.”

Aligned with PCORI

According to co-investigator Gilberto Lopes, M.D., chief of the Division of Medical Oncology and associate director for global oncology at Sylvester, the Sylvester mission is aligned with PCORI.

“We believe that research focused on patients, looking into interventions and strategies beyond surgery, radiation and systemic treatments, is paramount so we can reach better quality of life and cure rates,” said Dr. Lopes.

Finding ways to help survivors thrive has long been a focus of Dr. Crane’s research. By 2040, there will be more than 26 million cancer survivors nationally, with almost 75% of them over age 65, the researchers noted. Following a diagnosis, older cancer patients often experience declines in mental and physical abilities. While big strides have been made in the successful treatment of cancer, survivors are at elevated risks for post-treatment functional and cognitive declines, cardiovascular disease and more.

“With the growing number of survivors, the faster biological aging of breast cancer patients, as well as the ‘silver tsunami’ phenomena, the need to determine the best way to deliver an effective lifestyle intervention is immediate and crucial. I look forward to seeing the results of this team’s work,” said study co-investigator Carmen Calfa, M.D., medical co-director, Cancer Survivorship and Translational Behavioral Sciences, associate director of community outreach and assistant professor of clinical medicine at Sylvester.

“Over the past decade, advances in cancer treatment have dramatically improved survival rates. However, consequences of treatment may linger into survivorship and may be more pronounced for older cancer survivors,” Dr. Crane said. “These risks to health and wellness are not limited to cancer survivors. Studies have found that caregivers may also experience declines in physical function and cognition.”

Along those lines, bringing together additional co-investigators, such as Drs. Lopes and Calfa and David Loewenstein, Ph.D., who can provide additional insight, is paramount for the study, Dr. Crane explained. Through a multidisciplinary study approach, the best results can be obtained.

“I am honored to be a co-investigator on this innovative study of behavioral and lifestyle interventions designed to enhance the brain health and quality of life among older adult cancer patients and their caregivers,” said Dr. Loewenstein, professor of psychiatry and behavioral sciences and director of the Center for Cognitive Neurosciences and Aging, part of the Department of Psychiatry and Behavioral Sciences at Miller School. “This is an example of team and translational science at its finest.”

Study Approach and Goals

The five-year project, “VITALITY: Comparative Effectiveness of Lifestyle Interventions for Older Cancer Survivors and Their Caregivers,” expected to begin in spring 2024, will evaluate the effectiveness of supervised and unsupervised exercise and diet interventions in pairs of older cancer patients and their caregivers. Essentially, the study will compare a “high-touch” exercise and diet intervention (virtually delivered and exercise trainer- and dietitian-supervised) to a “low-touch” intervention that involves text messaging, wearable fitness trackers and general supportive materials (without trainer or dietitian supervision).

“Our study seeks to determine the best way to deliver a lifestyle intervention,” explained Dr. Crane. “With advances in digital health, especially wearable devices, it’s important to understand how effective this lower-cost method can be versus the gold standard of one-on-one supervised programs.”

The researchers plan to recruit a total of 763 patient-caregiver pairs from each organization’s respective service area. Prospective patients must be age 65 or older and have completed treatment for lung, breast, colorectal or prostate cancer within the past year. Caregivers can be any age so long as they provide informal care for the patient.

Participants will be randomly assigned to either the supervised group, which will participate in exercise and nutrition sessions via videoconferencing to promote aerobic and resistance training and follow a Mediterranean diet pattern, or an unsupervised group whose participants will use wearable devices to track exercise activity and follow the same diet pattern. Both interventions will last six months and participants will be evaluated at six- and 12-month intervals to measure the impact on mental and physical functioning as well as physical activity and diet.

“Our research has supported the accessibility and appeal of remotely delivered lifestyle interventions for cancer survivors, as well as the remarkable value survivors put on having their caregivers involved,” Dr. Crane said.

My Wellness Research

As a national leader in digital health innovations in lifestyle research, Dr. Crane develops and leverages technology, including the recently deployed My Wellness Research platform, to support and deliver community-based research. In this study, Dr. Crane and the team will synchronize wearable fitness trackers directly into the platform to monitor participants remotely and analyze data in real time. Investigators will communicate with participants either via text message or videoconferencing, all through the centralized My Wellness Research platform.

“PCORI’s goal is to develop resources for real-world implementation, to improve patient-centered outcomes. At the end of this trial, the programs and materials we develop will go to PCORI and the broader oncology community, with the goal of making these programs and materials available to all providers,” Dr. Crane said.

The funding award has been approved pending the completion of a business and programmatic review by PCORI staff and the issuance of a formal award contract.

Tags: Cancer Control Research Program, cancer survivorship, Cancer Survivorship Program, Dr. Carmen Calfa, Dr. David Loewenstein, Dr. Gilberto Lopes, Dr. Tracy Crane, My Wellness Research, PCORI, USNWR Oncology