Post-PCa symptom program found feasible

Chicago-A personally tailored program for self-management of post-treatment symptoms in prostate cancer survivors is feasible, according to results of a prospective study, which also showed that the program generates strong patient interest and improvements in quality of life.

University of Michigan researchers reported the findings at the American Society of Clinical Oncology annual meeting in Chicago.

Recruiting men receiving care through the Veterans Health Administration, the study included 556 prostate cancer survivors who were 1 to 10 years post-treatment and experiencing burden from treatment-related symptoms. They were randomized to receive the tailored intervention or a single non-tailored informational newsletter.

Change in symptom burden and associated prostate cancer-related quality of life at 5 months after enrollment assessed using the 26-item Expanded Prostate Index Composite (EPIC-26) was analyzed as the primary outcome, and no statistically significant differences were found between study groups. However, a secondary outcome analysis showed that among men receiving the tailored intervention, those who identified urinary or sexual symptoms as their primary focus had statistically significant improvements from baseline in the EPIC-26 domain scores for their leading concern and in multiple other domains.

“The tailored program represents a low-cost, scalable intervention to address a large gap in care for prostate cancer survivors,” said lead author Ted Skolarus, MD, MPH, associate professor of urology, University of Michigan, and core investigator at the Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor.

“Although our study did not find significant differences in overall outcomes between the intervention and control groups, considering the improvements from baseline in specific symptom domains along with the strong interest in the study by our patient cohort, we believe population-based tailored approaches to support self-management of prostate cancer treatment-related side effects are warranted.”

Alicia K. Morgans, MD, MPH, associate professor of medicine at Northwestern University Feinberg School of Medicine, Chicago, reviewed the study in a discussion session. She concluded that its results suggest that patient-centered care at the systems level has potential to improve outcomes for men with prostate cancer.

“We know that many prostate cancer survivors experience symptoms and long-term effects from treatment that negatively affect their quality of life, and some studies have suggested that symptoms can be ameliorated or eliminated through self-management techniques. Telehealth support between clinic visits may enable systems to support patients more effectively and do so in a way that is scalable in our already burdened health care system,” she said.

How the program works

In the tailored program, which is named “Building Your New Normal,” men received a total of four automated telephone calls at monthly intervals to gather information about ongoing urinary, bowel, sexual, emotional, and general symptoms. They were asked to prioritize one symptom area, which together with information from their other responses and pertaining to branch of service, age, race, and treatment type was used to develop content for a newsletter to guide self-management. The newsletters were developed at the University of Michigan Center for Health Communications Research, which is a designated Center of Excellence for Cancer Communications by the National Cancer Institute.

Data on study participation and individual feedback showed high patient engagement and enthusiasm for the program, Dr. Skolarus said. Target enrollment was achieved relatively quickly, 85% of men in the tailored intervention group received at least three of the four possible newsletters, 89% completed the outcomes assessment at 5 months, and >80% reported satisfaction with or recommended the program.

As a next step, the authors will be analyzing medical and pharmacy claims to investigate how the tailored self-management materials might impact health care utilization. They are also planning analyses to explore the idea that the self-management engagement might have a greater positive impact if it is initiated closer to the time of prostate cancer diagnosis and treatment.

“Approximately one-third of the participants were 1 to 2 years post-treatment, one-third were 3 to 4 years post-treatment, and for the remaining men, at least 5 years had passed since they received initial treatment,” Dr. Skolarus told Urology Times. “Comments we received from men during the process evaluation indicated a desire to have had the self-management materials available earlier in their disease history.”