Although there have been significant advancements in the treatment of prostate cancer with medications, radiation, surgery and/or brachytherapy, there continue to be concerns about posttreatment side effects. Although the advancements in these treatments have aimed to limit associated adverse events, patients still frequently develop urologic (impotence, urinary incontinence) and gastrointestinal (tenesmus, hematochezia) symptoms.1,2 These treatment-related adverse events can have a significant impact on a patient’s quality of life (QoL).3 In addition to these stressors, patients may also be concerned about potential cancer recurrence.
QoL can be challenging to objectively measure, and even when it can be accurately measured, it can be even more challenging to develop new modalities targeting improvements in these patient QoL factors. Therefore, a recent prostate cancer study conducted by Skolarus and colleagues aimed to evaluate whether an automated telephone system that identified specific posttreatment symptoms coupled with a subsequent targeted newsletter could help reduce symptom burden.2
The study was a randomized, controlled trial that enrolled a total of 556 men aged between 40 and 80 years old with prostate cancer who reported persistent symptoms more than 1 year after treatment. The authors named their intervention the “Building Your New Normal” initiative, which used automated telephone technology to deliver tailored newsletters to patients regarding the self-management of their specific prostate cancer-related symptoms.
The intervention group would receive an automated telephone call and their symptoms would be assessed using the EPIC system. In addition, they were given the opportunity to choose a particular symptom domain that would generate a newsletter tailored to their specific symptoms.
This intervention group was compared with a control group that only received a single nonspecific newsletter. The authors hypothesized that the intervention group would have less symptom burden as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC) at both 5 months (primary end point) and 12 months (secondary end point) poststudy enrollment for each of the 4 symptom “domains”: sexual, bowel, urinary, and general. Each of the 4 domains was graded using a scale from 0 to 100, for which a score greater than 70 was considered clinically meaningful. A higher score indicated less symptom burden.
This program had been tested in prior studies that had a National Cancer Institute (NCI) designation.
Of the 556 patients that initially enrolled in the study, 90.7% and 81.7% provided the primary outcomes at 5 months and 12 months, respectively. It is important to note that the intervention arm had fewer patients with less than high school education (2.5% vs 9%, respectively) and more patients with college education (54.3% vs 48.2%, respectively) compared with the control arm.
Despite this discrepancy, there was no difference in baseline EPIC scores between the groups; 75.5% of patients in the intervention arm received all 4 domain newsletters. The most common initial symptom domain chosen by a patient was sexual health followed by urinary, bowel, and general. Interestingly, close to 80% of patients never chose to receive information regarding bowel symptoms.
At the primary end point of 5-month follow-up, there were no statistically significant differences between the groups in their EPIC scores (based on a significance level of P =.0125). Similarly, there were no differences in symptom self-management, perceived efficacy in patient-physician interactions (PEPPI), or cancer control and outlook.
The results were similar at 12 months except that the intervention group had slightly higher confidence in symptom management using a 5-15 scale (13.5 vs 12.9, P =.01). Interestingly, the intervention group also had slightly lower scores on the 12-item veteran QoL scale (VR-12, 2.2 vs 2.3, P =.02).
This study highlights several key points. Despite the time-intensive commitment needed for the primary end point (four 30-minute calls over 4 months), many patients remained in the study. This retention rate is impressive and does show a high level of engagement even if the differences in results were not statistically significant.
Patients appeared to be most concerned with symptoms associated with sexual health and least concerned with bowel symptoms. The authors postulated that the lack of statistical significance could have been secondary to many of these patients dealing with these symptoms for many years, so an automated system may have not been as interactive and/or intriguing for them. It is also important to note that the authors used .0125 as the level of significance based on their statistical analyses. Even though there were minimal statistical differences between the groups, the costs of the actual interventions were relatively minimal.
When reviewing this study, it is important to note some of its limitations. The patient population was drawn solely from four Veterans Affairs (VA) sites in the Midwest, which isn’t necessarily representative of all of the patients with prostate cancer in the United States. There were also some noteworthy education gaps between the 2 groups at baseline, with the intervention group having higher levels of education.
As many patients continue to develop an interest in individualized medicine, programs such as the “Building Your New Normal” could undergo improvements and transformations in the future. Obviously this type of intervention does not replace the services of a health care practitioner, but it could serve as an adjunct to improving patient realization of their symptoms and encourage them to seek out additional medical care.
It would be interesting to see if the patients who were enrolled in the intervention arm were able to possibly prevent cancer recurrence, were more adherent with follow-up visits and testing, had fewer hospital admissions, and had smaller or larger overall long-term health care costs. It would also be interesting if a similar study could be conducted using more advanced technology, such as an application that could be downloaded to a phone or tablet.
- Skolarus TA, Wittmann D, Hawley ST. Enhancing prostate cancer survivorship care through self-management. Urol Oncol. 2017;35(9):567-568.
- Skolarus TA, Metreger T, Wittmann D, et al. Self-management in long-term prostate cancer survivors: a randomized, controlled trial. J Clin Oncol. 2019;37(15);1326-1335.
- Dandapani SV, Sanda MG. Measuring health-related quality of life consequences from primary treatment for early-stage prostate cancer. Semin Radiat Oncol. 2008;18(1):67-72.
This article originally appeared on Cancer Therapy Advisor