Prostate Cancer
Conditions
Keywords
prostate cancer, survivorship, intervention, telemedicine
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.
Interventions
BEHAVIORALInteractive 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.
BEHAVIORALTailored 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confidence in Symptom Self-Management | 5 months | 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. |
| The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative | Baseline | 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 Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive | Baseline | 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 Expanded Prostate Cancer Index (EPIC) - Bowel Health | Baseline | 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 Expanded Prostate Cancer Index (EPIC) - Sexual Health | Baseline | 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 Expanded Prostate Cancer Index (EPIC) - General Health | Baseline | 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 Expanded Prostate Cancer Index (EPIC) - EPIC-26 Mean | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cancer Outlook | 5 months | 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. |
| Perceived Efficacy in Patient-Physician Interactions (PEPPI) - 5-item Short Form | 5 months | 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. |
| Brief Cope - 6 Items | 5 months | 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. |
| Veteran Quality of Life Scale (VR-12) - Physical Health, 2 Items | 12 months | 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. |
| Veteran Quality of Life Scale (VR-12) - Emotional Health, 3 Items | 12 months | 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. |
| Cancer Control | 5 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IVR Intervention 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. | 278 |
| Enhanced Usual Care 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. | 278 |
| Total | 556 |
Baseline characteristics
| Characteristic | IVR Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 204 Participants | 190 Participants | 394 Participants |
| Age, Categorical Between 18 and 65 years | 74 Participants | 88 Participants | 162 Participants |
| Age, Continuous | 67.2 years STANDARD_DEVIATION 5.7 | 66.2 years STANDARD_DEVIATION 7.1 | 66.7 years STANDARD_DEVIATION 6.4 |
| Race/Ethnicity, Customized Black | 74 Participants | 83 Participants | 157 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Other | 9 Participants | 15 Participants | 24 Participants |
| Race/Ethnicity, Customized White | 199 Participants | 186 Participants | 385 Participants |
| Region of Enrollment United States | 278 Participants | 278 Participants | 556 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 278 Participants | 278 Participants | 556 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 278 | 3 / 278 |
| other Total, other adverse events | 0 / 278 | 0 / 278 |
| serious Total, serious adverse events | 3 / 278 | 1 / 278 |
Outcome results
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.
Time frame: 5 months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | Confidence in Symptom Self-Management | 13.1 score on a scale | Standard Deviation 2.1 |
| Enhanced Usual Care | Confidence in Symptom Self-Management | 13.1 score on a scale | Standard Deviation 2.1 |
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.
Time frame: 12 months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | Confidence in Symptom Self-Management | 13.5 score on a scale | Standard Deviation 1.9 |
| Enhanced Usual Care | Confidence in Symptom Self-Management | 12.9 score on a scale | Standard Deviation 2.2 |
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.
Time frame: Baseline
Population: Thirty (5.4%) enrollees did not do EPIC-26, and two enrollees did only one or two subscales. EPIC-Bowel Health was not done in 32 persons.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | The Expanded Prostate Cancer Index (EPIC) - Bowel Health | 76.5 score on a scale | Standard Deviation 21.7 |
| Enhanced Usual Care | The Expanded Prostate Cancer Index (EPIC) - Bowel Health | 77.6 score on a scale | Standard Deviation 22.2 |
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.
Time frame: 12 Months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | The Expanded Prostate Cancer Index (EPIC) - Bowel Health | 79.2 score on a scale | Standard Deviation 20.7 |
| Enhanced Usual Care | The Expanded Prostate Cancer Index (EPIC) - Bowel Health | 81.0 score on a scale | Standard Deviation 21.7 |
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.
Time frame: 5 Months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | The Expanded Prostate Cancer Index (EPIC) - Bowel Health | 80.6 score on a scale | Standard Deviation 19 |
| Enhanced Usual Care | The Expanded Prostate Cancer Index (EPIC) - Bowel Health | 79.8 score on a scale | Standard Deviation 21.6 |
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.
Time frame: Baseline
Population: Average of 5 EPIC-26 subscales based on 524 person data (260 in control and 264 in IVR group): 30 (5.4%) enrollees did not do EPIC-26, and two enrollees did only one or two subscales. EPIC-Urinary Health Irritative was not done in 30 persons, Urinary Health Obstructive in 31, Bowel Health in 32, Sexual Health in 58 and General Health in 32 persons
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | The Expanded Prostate Cancer Index (EPIC) - EPIC-26 Mean | 60.8 score on a scale | Standard Deviation 16.5 |
| Enhanced Usual Care | The Expanded Prostate Cancer Index (EPIC) - EPIC-26 Mean | 60.9 score on a scale | Standard Deviation 16.7 |
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.
Time frame: 12 Months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | The Expanded Prostate Cancer Index (EPIC) - General Health | 75.8 score on a scale | Standard Deviation 18.6 |
| Enhanced Usual Care | The Expanded Prostate Cancer Index (EPIC) - General Health | 73.5 score on a scale | Standard Deviation 20.7 |
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.
Time frame: 5 Months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | The Expanded Prostate Cancer Index (EPIC) - General Health | 74.8 score on a scale | Standard Deviation 21.3 |
| Enhanced Usual Care | The Expanded Prostate Cancer Index (EPIC) - General Health | 71.2 score on a scale | Standard Deviation 21.9 |
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.
Time frame: Baseline
Population: Thirty (5.4%) enrollees did not do EPIC-26, and two enrollees did only one or two subscales. EPIC-General Health was not done in 32 persons.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | The Expanded Prostate Cancer Index (EPIC) - General Health | 71.0 score on a scale | Standard Deviation 20.9 |
| Enhanced Usual Care | The Expanded Prostate Cancer Index (EPIC) - General Health | 67.9 score on a scale | Standard Deviation 21.5 |
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.
Time frame: 5 Months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | The Expanded Prostate Cancer Index (EPIC) - Sexual Health | 25.8 score on a scale | Standard Deviation 26.5 |
| Enhanced Usual Care | The Expanded Prostate Cancer Index (EPIC) - Sexual Health | 25.1 score on a scale | Standard Deviation 28.7 |
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.
Time frame: 12 Months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | The Expanded Prostate Cancer Index (EPIC) - Sexual Health | 29.3 score on a scale | Standard Deviation 29.7 |
| Enhanced Usual Care | The Expanded Prostate Cancer Index (EPIC) - Sexual Health | 26.5 score on a scale | Standard Deviation 30.9 |
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.
Time frame: Baseline
Population: Thirty (5.4%) enrollees did not do EPIC-26, and two enrollees did only one or two subscales. EPIC-Sexual Health was not done in 58 persons.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | The Expanded Prostate Cancer Index (EPIC) - Sexual Health | 21.6 score on a scale | Standard Deviation 25.5 |
| Enhanced Usual Care | The Expanded Prostate Cancer Index (EPIC) - Sexual Health | 21.8 score on a scale | Standard Deviation 26.3 |
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.
Time frame: Baseline
Population: Thirty (5.4%) enrollees did not do EPIC-26.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative | 60.1 score on a scale | Standard Deviation 28.2 |
| Enhanced Usual Care | The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative | 61.4 score on a scale | Standard Deviation 28.9 |
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.
Time frame: 5 Months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative | 63.4 score on a scale | Standard Deviation 29.5 |
| Enhanced Usual Care | The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative | 61.8 score on a scale | Standard Deviation 28.5 |
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.
Time frame: 12 Months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative | 62.8 score on a scale | Standard Deviation 29.7 |
| Enhanced Usual Care | The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative | 63.6 score on a scale | Standard Deviation 29.3 |
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.
Time frame: 5 Months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive | 77.4 score on a scale | Standard Deviation 19.7 |
| Enhanced Usual Care | The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive | 74.5 score on a scale | Standard Deviation 20.2 |
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.
Time frame: 12 Months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive | 76.3 score on a scale | Standard Deviation 19 |
| Enhanced Usual Care | The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive | 75.1 score on a scale | Standard Deviation 20 |
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.
Time frame: Baseline
Population: Thirty (5.4%) enrollees did not do EPIC-26, and two enrollees did only one or two subscales. EPIC-Urinary Health Obstructive was not done in 31 persons.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive | 72.7 score on a scale | Standard Deviation 20 |
| Enhanced Usual Care | The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive | 72.5 score on a scale | Standard Deviation 20.1 |
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.
Time frame: 12 months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | Brief Cope - 6 Items | 2.7 score on a scale | Standard Deviation 0.9 |
| Enhanced Usual Care | Brief Cope - 6 Items | 2.6 score on a scale | Standard Deviation 1 |
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.
Time frame: 5 months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | Brief Cope - 6 Items | 2.8 score on a scale | Standard Deviation 0.9 |
| Enhanced Usual Care | Brief Cope - 6 Items | 2.6 score on a scale | Standard Deviation 1 |
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.
Time frame: 5 months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | Cancer Control | 9.6 score on a scale | Standard Deviation 2.1 |
| Enhanced Usual Care | Cancer Control | 9.6 score on a scale | Standard Deviation 2.2 |
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.
Time frame: 12 months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | Cancer Control | 9.4 score on a scale | Standard Deviation 1.7 |
| Enhanced Usual Care | Cancer Control | 9.4 score on a scale | Standard Deviation 1.8 |
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.
Time frame: 12 months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | Cancer Outlook | 7.1 score on a scale | Standard Deviation 2 |
| Enhanced Usual Care | Cancer Outlook | 6.8 score on a scale | Standard Deviation 2.2 |
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.
Time frame: 5 months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | Cancer Outlook | 7.2 score on a scale | Standard Deviation 2.2 |
| Enhanced Usual Care | Cancer Outlook | 7.3 score on a scale | Standard Deviation 2.3 |
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.
Time frame: 12 months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | Perceived Efficacy in Patient-Physician Interactions (PEPPI) - 5-item Short Form | 21.5 score on a scale | Standard Deviation 4.3 |
| Enhanced Usual Care | Perceived Efficacy in Patient-Physician Interactions (PEPPI) - 5-item Short Form | 21.7 score on a scale | Standard Deviation 4.5 |
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.
Time frame: 5 months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | Perceived Efficacy in Patient-Physician Interactions (PEPPI) - 5-item Short Form | 21.8 score on a scale | Standard Deviation 3.9 |
| Enhanced Usual Care | Perceived Efficacy in Patient-Physician Interactions (PEPPI) - 5-item Short Form | 21.9 score on a scale | Standard Deviation 3.8 |
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.
Time frame: 12 months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | Veteran Quality of Life Scale (VR-12) - Emotional Health, 3 Items | 3.7 score on a scale | Standard Deviation 0.6 |
| Enhanced Usual Care | Veteran Quality of Life Scale (VR-12) - Emotional Health, 3 Items | 3.6 score on a scale | Standard Deviation 0.7 |
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.
Time frame: 12 months
Population: N with non-missing data for the specific measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVR Intervention | Veteran Quality of Life Scale (VR-12) - Physical Health, 2 Items | 2.2 score on a scale | Standard Deviation 0.7 |
| Enhanced Usual Care | Veteran Quality of Life Scale (VR-12) - Physical Health, 2 Items | 2.3 score on a scale | Standard Deviation 0.7 |