An interventional study of Interactive Voice Response Symptom Management and Tailored Newsletters in Prostate Cancer, sponsored by VA Office of Research and Development. Completed at 4 sites in United States. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-05-07.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Supportive care
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.
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.
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Exclusion Criteria:
The intervention will consist of two components, both with content design based on established theories for self-management support: 1) automated telephone monitoring of PC survivor symptoms and goals for symptom reduction, based on a patient empowerment approach, and 2) personally tailored newsletters that 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. Intervention-group participants will receive four automated assessment and self-management support calls over a 3-month period (at baseline, 1-month, 2-month, 3-months). Information collected during automated phone assessments will be used to construct tailored newsletters, which will be sent following each automated call.
Behavioral: Interactive Voice Response Symptom Management · Behavioral: Tailored Newsletters
Because of the strong evidence documenting symptom burden in PC survivors, the investigators believe that providing control subjects with some information about symptom self-management is warranted. The investigators further believe, based on the investigators' prior experience conducting RCTs, that offering some type of educational material for Veterans randomized to the control arm will increase their willingness to enroll in the study (as opposed to a pure usual care arm where they would not receive any such materials). Therefore, survivors randomized to the control condition will receive written material at the time of enrollment designed to educate them about PC symptoms and symptom management. Material will be approximately six pages in length, also written at or below an 8th grade reading level, and will include a summary of common symptoms experienced by prostate cancer survivors.
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.
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.
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: 5 Months
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.
Time frame: 5 Months
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.
Time frame: 5 Months
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.
Time frame: 5 Months
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.
Time frame: 5 Months
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.
Time frame: 12 Months
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.
Time frame: 12 Months
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.
Time frame: 12 Months
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.
Time frame: 12 Months
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.
Time frame: 12 Months
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.
Time frame: 5 months
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.
Time frame: 12 months
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.
Time frame: 5 months
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.
Time frame: 12 months
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.
Time frame: 5 months
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.
Time frame: 12 months
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.
Time frame: 5 months
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.
Time frame: 12 months
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.
Time frame: 5 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
| Milestone | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| Started | 278 | 278 |
| Completed | 261 | 269 |
| Not completed | 17 | 9 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative | 60.1 ± 28.2 | 61.4 ± 28.9 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive | 72.7 ± 20.0 | 72.5 ± 20.1 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| The Expanded Prostate Cancer Index (EPIC) - Bowel Health | 76.5 ± 21.7 | 77.6 ± 22.2 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| The Expanded Prostate Cancer Index (EPIC) - Sexual Health | 21.6 ± 25.5 | 21.8 ± 26.3 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| The Expanded Prostate Cancer Index (EPIC) - General Health | 71.0 ± 20.9 | 67.9 ± 21.5 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| The Expanded Prostate Cancer Index (EPIC) - EPIC-26 Mean | 60.8 ± 16.5 | 60.9 ± 16.7 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative | 63.4 ± 29.5 | 61.8 ± 28.5 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive | 77.4 ± 19.7 | 74.5 ± 20.2 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| The Expanded Prostate Cancer Index (EPIC) - Bowel Health | 80.6 ± 19.0 | 79.8 ± 21.6 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| The Expanded Prostate Cancer Index (EPIC) - Sexual Health | 25.8 ± 26.5 | 25.1 ± 28.7 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| The Expanded Prostate Cancer Index (EPIC) - General Health | 74.8 ± 21.3 | 71.2 ± 21.9 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative | 62.8 ± 29.7 | 63.6 ± 29.3 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive | 76.3 ± 19.0 | 75.1 ± 20.0 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| The Expanded Prostate Cancer Index (EPIC) - Bowel Health | 79.2 ± 20.7 | 81.0 ± 21.7 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| The Expanded Prostate Cancer Index (EPIC) - Sexual Health | 29.3 ± 29.7 | 26.5 ± 30.9 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| The Expanded Prostate Cancer Index (EPIC) - General Health | 75.8 ± 18.6 | 73.5 ± 20.7 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| Confidence in Symptom Self-Management | 13.1 ± 2.1 | 13.1 ± 2.1 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| Confidence in Symptom Self-Management | 13.5 ± 1.9 | 12.9 ± 2.2 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| Cancer Control | 9.6 ± 2.1 | 9.6 ± 2.2 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| Cancer Control | 9.4 ± 1.7 | 9.4 ± 1.8 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| Cancer Outlook | 7.2 ± 2.2 | 7.3 ± 2.3 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| Cancer Outlook | 7.1 ± 2.0 | 6.8 ± 2.2 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| Perceived Efficacy in Patient-Physician Interactions (PEPPI) - 5-item Short Form | 21.8 ± 3.9 | 21.9 ± 3.8 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| Perceived Efficacy in Patient-Physician Interactions (PEPPI) - 5-item Short Form | 21.5 ± 4.3 | 21.7 ± 4.5 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| Brief Cope - 6 Items | 2.8 ± 0.9 | 2.6 ± 1.0 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| Brief Cope - 6 Items | 2.7 ± 0.9 | 2.6 ± 1.0 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| Veteran Quality of Life Scale (VR-12) - Physical Health, 2 Items | 2.2 ± 0.7 | 2.3 ± 0.7 |
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.
| score on a scale | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| Veteran Quality of Life Scale (VR-12) - Emotional Health, 3 Items | 3.7 ± 0.6 | 3.6 ± 0.7 |
Collected over Adverse event data was collected from the start of recruitment on 4/17/15 through the final 12-month assessment on 2/2/18.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IVR Intervention | 1/278 (0.4%) | 3/278 (1.1%) | 0/278 (0%) |
| Enhanced Usual Care | 3/278 (1.1%) | 1/278 (0.4%) | 0/278 (0%) |
| Event | IVR Intervention | Enhanced Usual Care |
|---|---|---|
| Hip arthroplastySurgical and medical procedures | 1/278 | 0/278 |
| Subdural hematomaNervous system disorders | 0/278 | 1/278 |
| Kidney FailureRenal and urinary disorders | 1/278 | 0/278 |
| StrokeVascular disorders | 1/278 | 0/278 |
| Age, Categorical(Participants) | IVR Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 74 | 88 | 162 |
| >=65 years | 204 | 190 | 394 |
| Age, Continuous(years) | IVR Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Mean | 67.2 ± 5.7 | 66.2 ± 7.1 | 66.7 ± 6.4 |
| Sex: Female, Male(Participants) | IVR Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 278 | 278 | 556 |
| Race/Ethnicity, Customized(Participants) | IVR Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| White | 199 | 186 | 385 |
| Black | 74 | 83 | 157 |
| Other | 9 | 15 | 24 |
| Hispanic | 4 | 5 | 9 |
| Region of Enrollment(Participants) | IVR Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| United States | 278 | 278 | 556 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Apr 2015 to primary completion in Feb 2018, 33 months.
Results were first posted in Apr 2019, 1 year 2 months after primary completion.
Of 1,018 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 87. This study's 33 months is below that.
Counting every sponsor, half of 1,063 studies reached it within 45 months; a quarter within 22 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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