Clinical trial NCT01900561: Optimizing Veteran-Centered Prostate Cancer Survivorship Care
Official title: Optimizing Veteran-Centered Prostate Cancer Survivorship Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
survivorship
intervention
telemedicine
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-07-16
Enrollment: 556
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will provide much needed information about how to optimize the quality of care and quality of life of Veterans who are survivors of prostate cancer.

Detailed description: Although there are nearly 150,000 prostate cancer survivors in the VA, there has been little research to understand and improve survivorship care for this large population of Veterans. A substantial proportion of prostate cancer survivors in the general population have significant side effects from treatment (surgery or radiation therapy) that often persist for years, including incontinence, erectile dysfunction, and metabolic syndrome, all of which can contribute to decreased quality of life. The investigators' pilot data suggests that VA prostate cancer survivors experience similar or worse symptom burden to that of the general population of survivors. To address the need to improve patient-centered survivorship care management for Veterans with prostate cancer, the investigators propose a 4 year study with two aims: 1) to conduct a randomized controlled trial to compare a personally tailored automated telephone symptom management intervention for improving symptoms and symptom self-management to usual care. The investigators expect that those in the intervention group will have more confidence in symptom self-management and better symptom self-management and prostate cancer quality of life following the intervention, and that these outcomes will translate to more efficient use of services for these Veterans, and 2) to compare utilization of services among those in the intervention group to those in the control group.

Eligibility criteria: Inclusion Criteria:

* Veteran patient at one of the four study sites (Ann Arbor VA, Cleveland VA, Pittsburgh VA, St. Louis VA)
* History of treatment for prostate cancer treated by surgery, radiation or androgen deprivation therapy between 1-10 years prior to identification

Exclusion Criteria:

* No phone number on file
* Not able to converse on the telephone in English
* Treated for metastatic disease or non-prostate cancer
* Dementia or other significant mental impairment

Primary outcomes:
measure: The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative
timeFrame: Baseline
measure: The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive
timeFrame: Baseline
measure: The Expanded Prostate Cancer Index (EPIC) - Bowel Health
timeFrame: Baseline
measure: The Expanded Prostate Cancer Index (EPIC) - Sexual Health
timeFrame: Baseline
measure: The Expanded Prostate Cancer Index (EPIC) - General Health
timeFrame: Baseline
measure: The Expanded Prostate Cancer Index (EPIC) - EPIC-26 Mean
timeFrame: Baseline
measure: The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative
timeFrame: 5 Months
measure: The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive
timeFrame: 5 Months
measure: The Expanded Prostate Cancer Index (EPIC) - Bowel Health
timeFrame: 5 Months
measure: The Expanded Prostate Cancer Index (EPIC) - Sexual Health
timeFrame: 5 Months
measure: The Expanded Prostate Cancer Index (EPIC) - General Health
timeFrame: 5 Months
measure: The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative
timeFrame: 12 Months
measure: The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive
timeFrame: 12 Months
measure: The Expanded Prostate Cancer Index (EPIC) - Bowel Health
timeFrame: 12 Months
measure: The Expanded Prostate Cancer Index (EPIC) - Sexual Health
timeFrame: 12 Months
measure: The Expanded Prostate Cancer Index (EPIC) - General Health
timeFrame: 12 Months
measure: Confidence in Symptom Self-Management
timeFrame: 5 months
measure: Confidence in Symptom Self-Management
timeFrame: 12 months
Secondary outcomes:
measure: Cancer Control
timeFrame: 5 months
measure: Cancer Control
timeFrame: 12 months
measure: Cancer Outlook
timeFrame: 5 months
measure: Cancer Outlook
timeFrame: 12 months
measure: Perceived Efficacy in Patient-Physician Interactions (PEPPI) - 5-item Short Form
timeFrame: 5 months
measure: Perceived Efficacy in Patient-Physician Interactions (PEPPI) - 5-item Short Form
timeFrame: 12 months
measure: Brief Cope - 6 Items
timeFrame: 5 months
measure: Brief Cope - 6 Items
timeFrame: 12 months
measure: Veteran Quality of Life Scale (VR-12) - Physical Health, 2 Items
timeFrame: 12 months
measure: Veteran Quality of Life Scale (VR-12) - Emotional Health, 3 Items
timeFrame: 12 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis VA Medical Center John Cochran Division, St. Louis, MO
state: Missouri
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Sarah T Hawley, PhD MPH BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Telem DA, Dimick J, Skolarus TA. Dissecting Surgeon Behavior: Leveraging the Theoretical Domains Framework to Facilitate Evidence-based Surgical Practice. Ann Surg. 2018 Mar;267(3):432-434. doi: 10.1097/SLA.0000000000002506. No abstract available.
citation: Skolarus TA, Wittmann D, Hawley ST. Enhancing prostate cancer survivorship care through self-management. Urol Oncol. 2017 Sep;35(9):564-568. doi: 10.1016/j.urolonc.2017.05.008. Epub 2017 Jun 13.
citation: Skolarus TA, Metreger T, Hwang S, Kim HM, Grubb RL 3rd, 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. doi: 10.1186/s13063-017-1925-4.
citation: Skolarus TA, Metreger T, Wittmann D, Hwang S, Kim HM, Grubb RL 3rd, Gingrich JR, Zhu H, Piette JD, Hawley ST. Self-Management in Long-Term Prostate Cancer Survivors: A Randomized, Controlled Trial. J Clin Oncol. 2019 May 20;37(15):1326-1335. doi: 10.1200/JCO.18.01770. Epub 2019 Mar 29.