Optimizing Veteran-Centered Prostate Cancer Survivorship Care

Prostate Cancer Clinical Trial

Official title:

Optimizing Veteran-Centered Prostate Cancer Survivorship Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900561
• Other study ID #: IIR 12-116
• Status: Completed
• Phase: N/A
• Start date: April 17, 2015
• Est. completion date: February 7, 2018

Study information

• Verified date: April 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 556
• Est. completion date: February 7, 2018
• Est. primary completion date: February 7, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Interactive Voice Response Symptom Management
The Interactive Voice Response (IVR) system will provide automated telephone monitoring of PC survivor symptoms and goals for symptom reduction, based on a patient empowerment approach.
• Tailored Newsletters
Personally tailored newsletters will incorporate elements of CBT to improve survivors' identification with the material, confidence/self-efficacy in symptom management, and to reduce common cognitive distortions related to successful implementation of behavior change. Information collected during automated phone assessments will be used to construct tailored newsletters, which will be sent following each automated call.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan
United States	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania
United States	St. Louis VA Medical Center John Cochran Division, St. Louis, MO	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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 Mar 29:JCO1801770. doi: 10.1200/JCO.18 — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative	The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.	Baseline
Primary	The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive	The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.	Baseline
Primary	The Expanded Prostate Cancer Index (EPIC) - Bowel Health	The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.	Baseline
Primary	The Expanded Prostate Cancer Index (EPIC) - Sexual Health	The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.	Baseline
Primary	The Expanded Prostate Cancer Index (EPIC) - General Health	The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.	Baseline
Primary	The Expanded Prostate Cancer Index (EPIC) - EPIC-26 Mean	The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.; The EPIC-26 mean is the average of the five EPIC subscales.	Baseline
Primary	The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative	The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.	5 Months
Primary	The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive	The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.	5 Months
Primary	The Expanded Prostate Cancer Index (EPIC) - Bowel Health	The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.	5 Months
Primary	The Expanded Prostate Cancer Index (EPIC) - Sexual Health	The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.	5 Months
Primary	The Expanded Prostate Cancer Index (EPIC) - General Health	The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.	5 Months
Primary	The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative	The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.	12 Months
Primary	The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive	The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.	12 Months
Primary	The Expanded Prostate Cancer Index (EPIC) - Bowel Health	The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.	12 Months
Primary	The Expanded Prostate Cancer Index (EPIC) - Sexual Health	The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.	12 Months
Primary	The Expanded Prostate Cancer Index (EPIC) - General Health	The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.	12 Months
Primary	Confidence in Symptom Self-Management	Confidence in symptom self-management was measured using a 5-item scale developed from our pilot work. Scores range from 5 to 15 with higher scores indicating higher level of confidence.	5 months
Primary	Confidence in Symptom Self-Management	Confidence in symptom self-management was measured using a 5-item scale developed from our pilot work. Scores range from 5 to 15 with higher scores indicating higher level of confidence.	12 months
Secondary	Cancer Control	We assessed perceived cancer control and outlook using five items from a validated measure developed to examine the psychosocial impact of prostate cancer. This measure, the Measuring Patients' Perceptions of the Outcomes of Treatment for Early PC instrument by Clark et al., includes three domains related to confidence that one's cancer is under control, worries about recurrence, and appraisals of one's coping with PC. Cancer control was assessed during the five- and 12-month follow-ups using two cancer control items from the instrument. Scores range from 2 to 10 and higher scores indicate higher confidence that cancer is under control.	5 months
Secondary	Cancer Control	We assessed perceived cancer control and outlook using five items from a validated measure developed to examine the psychosocial impact of prostate cancer. This measure, the Measuring Patients' Perceptions of the Outcomes of Treatment for Early PC instrument by Clark et al., includes three domains related to confidence that one's cancer is under control, worries about recurrence, and appraisals of one's coping with PC. Cancer control was assessed during the five- and 12-month follow-ups using two cancer control items from the instrument. Scores range from 2 to 10 and higher scores indicate higher confidence that cancer is under control.	12 months
Secondary	Cancer Outlook	We assessed perceived cancer control and outlook using five items from a validated measure developed to examine the psychosocial impact of prostate cancer. This measure, the Measuring Patients' Perceptions of the Outcomes of Treatment for Early PC instrument by Clark et al., includes three domains related to confidence that one's cancer is under control, worries about recurrence, and appraisals of one's coping with PC. Cancer outlook was assessed during the five- and 12-month follow-ups using three cancer outlook items from the instrument. Scores range from 3 to 15 and higher scores indicate more positive cancer outlook.	5 months
Secondary	Cancer Outlook	We assessed perceived cancer control and outlook using five items from a validated measure developed to examine the psychosocial impact of prostate cancer. This measure, the Measuring Patients' Perceptions of the Outcomes of Treatment for Early PC instrument by Clark et al., includes three domains related to confidence that one's cancer is under control, worries about recurrence, and appraisals of one's coping with PC. Cancer outlook was assessed during the five- and 12-month follow-ups using three cancer outlook items from the instrument. Scores range from 3 to 15 and higher scores indicate more positive cancer outlook.	12 months
Secondary	Perceived Efficacy in Patient-Physician Interactions (PEPPI) - 5-item Short Form	Self-efficacy in patient-physician interactions was assessed at 5 and 12 months using a five-item short form version of the Perceived Efficacy in Patient-Physician Interactions (PEPPI). The PEPPI was developed to measure older patients' self-efficacy in obtaining medical information and attention to their medical concerns from physicians. Scores range from 0-25 with higher scores indicating higher self-efficacy.	5 months
Secondary	Perceived Efficacy in Patient-Physician Interactions (PEPPI) - 5-item Short Form	Self-efficacy in patient-physician interactions was assessed at 5 and 12 months using a five-item short form version of the Perceived Efficacy in Patient-Physician Interactions (PEPPI). The PEPPI was developed to measure older patients' self-efficacy in obtaining medical information and attention to their medical concerns from physicians. Scores range from 0-25 with higher scores indicating higher self-efficacy.	12 months
Secondary	Brief Cope - 6 Items	We assessed participants' coping during the five- and 12-month follow-up assessments using six items from the 28-item Brief Cope instrument. This instrument measures emotion-focused, problem-focused, and dysfunctional coping and has been used in cancer survivors. Scores range from 1 to 5 with higher scores indicating better coping skills.	5 months
Secondary	Brief Cope - 6 Items	We assessed participants' coping during the five- and 12-month follow-up assessments using six items from the 28-item Brief Cope instrument. This instrument measures emotion-focused, problem-focused, and dysfunctional coping and has been used in cancer survivors. Scores range from 1 to 5 with higher scores indicating better coping skills.	12 months
Secondary	Veteran Quality of Life Scale (VR-12) - Physical Health, 2 Items	We assessed subjective physical health using 2 items from the VR-12 (SF-12 for veterans), an established measure of overall QOL that includes perceptions of one's health that may be impacted by prostate cancer. The scores range from 1- 3 and higher scores correspond to better health.	12 months
Secondary	Veteran Quality of Life Scale (VR-12) - Emotional Health, 3 Items	We assessed subjective emotional health using 3 items from the VR-12 (SF-12 for veterans), an established measure of overall QOL that includes perceptions of one's health that may be impacted by prostate cancer. The scores range from 1- 6 and higher scores correspond to better health.	12 months