BACKGROUND/RATIONALE:
Prostate Cancer (PC) is the most commonly diagnosed cancer in US veterans. Over 12,000 will be diagnosed with PC in 2016 joining more than 150,000 veteran PC survivors in the Veterans Health Administration (VA). Yet, there has been little systematic effort to understand the extent of veteran PC survivors' symptom burden (SB) or how it affects quality of life (QOL) and subsequent utilization of health services.

OBJECTIVE(S):
To determine whether a personalized automated telephone monitoring and self-management support intervention can effectively improve outcomes for veteran PC survivors.

Aim 1: To conduct a randomized controlled trial (RCT) among PC survivors with high SB comparing the impact of a personalized intervention to non-personalized information.

We hypothesized that relative to control patients (CG), veterans in the Building Your New Normal (BNN) intervention group (IG) would: 1) have higher confidence about symptom self management (SSM); and 2) report lower symptom burden (SB) and better disease-specific QOL at 5- and 12- months. We further hypothesized that the IG would have higher scores on key psychosocial indicators (subjective health and perceived cancer control).

Aim 2: To determine the intervention's impact on the use of VA services. We hypothesized that IG veterans would have a higher rate of evidence based symptom-specific service use at 12 months.

METHODS:
This was a two-armed RCT with an enrollment target of up to 325 PC survivors per arm. The IG received the BNN intervention. The CG received enhanced usual care, consisting of one non-tailored newsletter. The study protocol received ethical approval from VA Central Institutional Review Board (14-04).

We evaluated the impact of the intervention on primary outcomes of symptom burden and bother using the Expanded Prostate Cancer Index Composite (EPIC) measure and confidence in SSM, and secondary outcomes of cancer control and outlook, physician- patient interaction (PEPPI), and coping through follow up surveys at 5 and 12 months post enrollment. We assessed use of PC-related health services through administrative data. We conducted a process evaluation to assess prospects for broader dissemination and implementation.

FINDINGS/RESULTS:
There were no significant group differences at baseline. The average participant age was 66.7 years (range 49-83), most were married (54.3%), retired (62.4%), with over one-quarter identified as black race. The average time since diagnosis was 4.1 years (range 1.1-8.0). 46.2% received surgery, 56.7% radiation, and 24.8% androgen deprivation therapy. There were no group differences in any baseline screening question(s) or the EPIC. Of the 278 intervention subjects, 210 received all four newsletters (75.5%). Most chose one (93) or two (92) focus areas. The most common initial symptom focus area was sexual health, followed by urinary, bowel, and general. Sexual health was chosen at least once by three-quarters of intervention subjects.

At 5-months, mean EPIC scores were higher (i.e., less burden) in each domain in the IG, with the following adjusted mean differences: Urinary-irritative (+2.8), Urinary-obstructive (+3.1), Bowel (+0.7), Sexual (+1.4), General (+3.9). With the exception of General health (p=0.04), these were not statistically significant. We found no differences in confidence in SSM, cancer control and outlook, or PEPPI at 5-month, but.mean appraisal of coping score was higher in the IG by 0.2 (p=0.02). These results were similar at 12 months, with the exception of statistically significant higher mean score in the IG in confidence in SSM (13.5 vs. 12.9, adjusted p=0.03). At 12-months, subjective physical health was significantly lower in the IG than CG (2.2 vs. 2.3, p=0.007), but no differences in emotional health. We found significant differences by arm in EPIC domain scores of over 70 for the Urinary-irritative (p=0.02) and Urinary-obstructive domains (p=0.05).

Intervention group analyses: When evaluating change in EPIC scores from baseline to 5- and 12- months by participant primary symptom domains, we found subsequent improvement in corresponding domains averaged over 5 and 12 months. Veterans focusing on urinary health saw improvements of +3.0 EPIC points for irritative (p=0.02), and +5.6 EPIC points (p<0.001) in obstructive domains, respectively. For those focusing on bowel symptoms, +10.1 EPIC points (p<0.001); sexual symptoms, +7.2 EPIC points (p<0.001), general symptoms, +7.2 EPIC points (p=0.02). We found similar results when evaluating EPIC score changes from baseline to 5- and 12-months according to the symptom domain chosen at least once by subjects during the intervention.

Time since diagnosis was not associated with improvement in any of the EPIC domains, nor were varying degrees of "dose" (i.e., symptom area chosen more than once) for sexual or urinary health. 63% of intervention and 67% of control participants reported being very satisfied with the program. Many positive comments about the intervention were obtained from the process evaluation.

At 12 months, we identified 76 patients treated with procedures to address urinary, sexual, and bowel health with minimal differences between the CG and IG. While medications for urinary (91 control, 95 intervention, p=0.78) and sexual health (118 control, 104 intervention, p=0.82) were more common than procedures, no differences in prescriptions were noted. Nearly 70% of patients in both arms underwent PSA testing with no differences across groups (p=0.26).

IMPACT:
Although overall differences by arm were not seen, subgroup analyses revealed significant improvements in SB from baseline to follow up when evaluated according to initial symptom chosen. These findings suggest that interventions tailored to the chosen symptom have potential for positive impact in this population and reach clinically meaningful EPIC score changes. Veterans were highly engaged in the intervention and positive about it.

The intervention focused on helping Veterans who were long term PC survivors manage a symptom area of importance to them. We found an extraordinary amount of engagement with the automated symptom assessment and tailored intervention content, and BNN moved the needle on chosen symptoms in the IG. Further study regarding the implications of our intervention on health care delivery system utilization, and how the program might be modified to be more effective, appear warranted as engagement and unmet needs appear strong. Such information can provide better direction for survivors and their clinicians regarding how to optimize survivorship care both inside and outside of VA.

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External Links for this Project

NIH Reporter

Grant Number: I01HX001129-01A1
Link: https://reporter.nih.gov/project-details/8597074

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PUBLICATIONS:

Journal Articles

1. Telem DA, Dimick J, Skolarus TA. Dissecting Surgeon Behavior: Leveraging the Theoretical Domains Framework to Facilitate Evidence-based Surgical Practice. Annals of surgery. 2018 Mar 1; 267(3):432-434. [view]
2. Skolarus TA, Wittmann D, Hawley ST. Enhancing prostate cancer survivorship care through self-management. Urologic oncology. 2017 Sep 1; 35(9):564-568. [view]
3. Skolarus TA, Metreger T, Hwang S, Kim HM, Grubb RL, Gingrich JR, Hawley ST. Optimizing veteran-centered prostate cancer survivorship care: study protocol for a randomized controlled trial. Trials. 2017 Apr 18; 18(1):181. [view]
4. Skolarus TA, Metreger T, Wittmann D, Hwang S, Kim HM, Grubb RL, Gingrich JR, Zhu H, Piette JD, Hawley ST. Self-Management in Long-Term Prostate Cancer Survivors: A Randomized, Controlled Trial. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2019 May 20; 37(15):1326-1335. [view]

DRA: Health Systems, Cancer
DRE: Treatment - Comparative Effectiveness, Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: none
MeSH Terms: none