Chronic Hepatitis C, Genotype 1
Conditions
Keywords
HCV, Genotype1, Naive, Partial responder, Relapser
Brief summary
The purpose of this study is to evaluate the impact of a physician directed education program on treatment compliance of hepatitis C patients administered triple drug therapy of pegylated interferon, ribavirin and boceprevir.
Detailed description
The new treatment paradigm for HCV in the era of protease inhibitors will add a level of complexity that was previously not seen with pegylated interferon and ribavirin. In addition to new concepts such as utilization of a lead-in period, compliance with a TID dosing regimen of a third agent, development of resistance, and futility rules and decision points have yet to be assessed in a real life practice setting. The OPTIMAL trial is designed to evaluate the impact of an education program for community sites participating in a CLDF study treating chronic HCV genotype 1 patients. Group A will be comprised of approximately 30 CLDF designated Hepatology Centers of Educational Expertise (HCEE) and Group B will be comprised of approximately 60 community sites. Group A will also deliver the educational program regarding the use of HCV protease inhibitors, and the overall treatment of HCV to approximately two (2) community sites in it's geographic region. Group B will be comprised of community sites that have no previous clinical trial experience with boceprevir or an HCV protease inhibitor. For the purpose of this study, each community site in Group B will be assigned to an HCEE.
Interventions
PROCEDUREEducational Intervention
Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes.
OTHERPatient education and management skills training
Community sites received patient education and management skills training by HCEE investigators during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes.
Sponsors
SCRI Development Innovations, LLC
Merck Sharp & Dohme LLC
Chronic Liver Disease Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic Hepatitis C (HCV) genotype 1 * Detectable HCV-RNA within 180 days of screening * Age ≥ 18 years * Weight \> 40 kg * Patient and partner(s) must agree to use acceptable methods of contraception * Written informed consent
Exclusion criteria
* Known co-infection with HIV or HBV * Previous interferon or ribavirin regimen requiring discontinuation for an adverse event considered related to ribavirin and/or interferon * Currently taking or planning on taking any prohibited medications * Evidence of decompensated liver disease including the presence of clinical ascites, bleeding varices, or hepatic encephalopathy * Diabetes and/or hypertension with clinically significant ocular examination findings * Pre-existing psychiatric condition(s) * History of severe and uncontrolled psychiatric disorders * Active alcohol or drug abuse (not including marijuana) * Pre-existing medical condition that could interfere with the patient's participation in the study * Chronic obstructive pulmonary disease * Abnormal lab values
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Duration Compliance Rate | End of treatment up to treatment week 48 | The primary objective will be to define treatment duration compliance rate (calculated as the actual treatment duration in weeks divided by the expected duration in weeks) based on individual patient treatment goals as defined in the OPTIMAL protocol for HCV patients treated with boceprevir, peginterferon and ribavirin for up to 48 weeks. Rates will be reported for HCEEs (Group A) and community sites enrolled in the Program (Group B). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug Exposure | End of treatment up to treatment week 48 | Total number of patients receiving treatment over specified time intervals. |
| Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs. | Follow-up week 24 | Rate of SVR was defined as the percentage of participants with HCV-RNA undetectable at follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. |
| Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Baseline, end of treatment, follow-up week 24 | Determination of the quality of life for HCV patients treated with boceprevir, peginterferon and ribavirin at community sites and at HCEEs. Patient scores per subscale (8) were obtained by subtracting the lowest possible raw score from the actual raw score x 100, divided by the lowest possible raw score subtracted from the highest possible raw score. Subscale scores were averaged (with standard deviation) for Group A and Group B. Composite Scores are standardized to the general US population having a mean of 50 and a standard deviation of 10. Higher score = improved quality of life. |
| Number of Participants With Adverse Events | Throughout entire study, at end of treatment and follow up week 24 | Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A - HCEE Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.
No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes. | 84 |
| Group B - Community Sites Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor
Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes. | 113 |
| Total | 197 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Investigator judgement | 0 | 2 |
| Overall Study | Lost to Follow-up | 16 | 24 |
| Overall Study | Other or Unknown | 12 | 25 |
| Overall Study | Withdrawn consent | 3 | 0 |
Baseline characteristics
| Characteristic | Total | Group A - HCEE | Group B - Community Sites |
|---|---|---|---|
| Age, Continuous | 52.0 years STANDARD_DEVIATION 11.29 | 52.3 years STANDARD_DEVIATION 11.37 | 51.7 years STANDARD_DEVIATION 11.27 |
| Hepatitis C Virus Genotype 1a | 138 participants | 62 participants | 76 participants |
| Hepatitis C Virus Genotype 1b | 57 participants | 22 participants | 35 participants |
| Hepatitis C Virus Genotype Missing | 2 participants | 0 participants | 2 participants |
| Patient Status Compensated Cirrhotic | 17 participants | 9 participants | 8 participants |
| Patient Status Historic Null Responder | 25 participants | 16 participants | 9 participants |
| Patient Status Previous Partial Responder | 17 participants | 12 participants | 5 participants |
| Patient Status Relapsed | 39 participants | 17 participants | 22 participants |
| Patient Status Treatment Naive | 99 participants | 30 participants | 69 participants |
| Race/Ethnicity, Customized Asian | 5 participants | 3 participants | 2 participants |
| Race/Ethnicity, Customized Black/African American | 42 participants | 19 participants | 23 participants |
| Race/Ethnicity, Customized Caucasian | 125 participants | 50 participants | 75 participants |
| Race/Ethnicity, Customized Latino | 21 participants | 11 participants | 10 participants |
| Race/Ethnicity, Customized Other | 4 participants | 1 participants | 3 participants |
| Sex: Female, Male Female | 95 Participants | 31 Participants | 64 Participants |
| Sex: Female, Male Male | 102 Participants | 53 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 77 / 84 | 92 / 113 |
| serious Total, serious adverse events | 6 / 84 | 8 / 113 |
Outcome results
Primary
Treatment Duration Compliance Rate
The primary objective will be to define treatment duration compliance rate (calculated as the actual treatment duration in weeks divided by the expected duration in weeks) based on individual patient treatment goals as defined in the OPTIMAL protocol for HCV patients treated with boceprevir, peginterferon and ribavirin for up to 48 weeks. Rates will be reported for HCEEs (Group A) and community sites enrolled in the Program (Group B).
Time frame: End of treatment up to treatment week 48
Population: Population analyzed represents patients who had a PCR at treatment weeks where expected duration of treatment could have been determined. Subjects who discontinued the study due to Treatment Futility were considered to have 100% treatment duration compliance.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group A - HCEE | Treatment Duration Compliance Rate | 85.4 Percentage of compliance |
| Group B - Community Sites | Treatment Duration Compliance Rate | 83.8 Percentage of compliance |
p-value: 0.4864ANOVA
Secondary
Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.
Rate of SVR was defined as the percentage of participants with HCV-RNA undetectable at follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.
Time frame: Follow-up week 24
Population: Follow-up SVR includes data collected 10 weeks or greater from last treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A - HCEE | Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs. | Positive (percent) | 23.8 percentage of participants |
| Group A - HCEE | Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs. | Negative (percent) | 48.8 percentage of participants |
| Group A - HCEE | Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs. | Missing (percent) | 27.4 percentage of participants |
| Group B - Community Sites | Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs. | Negative (percent) | 46.0 percentage of participants |
| Group B - Community Sites | Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs. | Positive (percent) | 26.5 percentage of participants |
| Group B - Community Sites | Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs. | Missing (percent) | 27.4 percentage of participants |
Secondary
Drug Exposure
Total number of patients receiving treatment over specified time intervals.
Time frame: End of treatment up to treatment week 48
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A - HCEE | Drug Exposure | Days 1-7 | 84 participants |
| Group A - HCEE | Drug Exposure | Days 15-28 | 83 participants |
| Group A - HCEE | Drug Exposure | Days 85-168 | 73 participants |
| Group A - HCEE | Drug Exposure | Days 8-14 | 84 participants |
| Group A - HCEE | Drug Exposure | Days 169-252 | 49 participants |
| Group A - HCEE | Drug Exposure | Days 29-56 | 81 participants |
| Group A - HCEE | Drug Exposure | Days >252 | 26 participants |
| Group A - HCEE | Drug Exposure | Days 57-84 | 78 participants |
| Group B - Community Sites | Drug Exposure | Days >252 | 30 participants |
| Group B - Community Sites | Drug Exposure | Days 1-7 | 113 participants |
| Group B - Community Sites | Drug Exposure | Days 8-14 | 112 participants |
| Group B - Community Sites | Drug Exposure | Days 15-28 | 110 participants |
| Group B - Community Sites | Drug Exposure | Days 29-56 | 108 participants |
| Group B - Community Sites | Drug Exposure | Days 57-84 | 100 participants |
| Group B - Community Sites | Drug Exposure | Days 85-168 | 91 participants |
| Group B - Community Sites | Drug Exposure | Days 169-252 | 75 participants |
Secondary
Number of Participants With Adverse Events
Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs
Time frame: Throughout entire study, at end of treatment and follow up week 24
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A - HCEE | Number of Participants With Adverse Events | 77 participants |
| Group B - Community Sites | Number of Participants With Adverse Events | 95 participants |
Secondary
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Determination of the quality of life for HCV patients treated with boceprevir, peginterferon and ribavirin at community sites and at HCEEs. Patient scores per subscale (8) were obtained by subtracting the lowest possible raw score from the actual raw score x 100, divided by the lowest possible raw score subtracted from the highest possible raw score. Subscale scores were averaged (with standard deviation) for Group A and Group B. Composite Scores are standardized to the general US population having a mean of 50 and a standard deviation of 10. Higher score = improved quality of life.
Time frame: Baseline, end of treatment, follow-up week 24
Population: The Quality of Life scores are derived from the responses from subjects who completed questionnaires at protocol-scheduled timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Physical Role Functioning - Baseline | 71.0 score | Standard Deviation 40.16 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Physical Component Score - Follow-up week | 49.2 score | Standard Deviation 8.75 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Physical Role Functioning - End of treatment | 47.1 score | Standard Deviation 42.96 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Emotional Role Functioning - End of treatment | 61.1 score | Standard Deviation 42.15 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Physical Role Functioning - Follow-up week | 80.7 score | Standard Deviation 31.38 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Mental Component Score - Baseline | 52.2 score | Standard Deviation 8.78 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Bodily Pain - Baseline | 63.1 score | Standard Deviation 29.62 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Mental Health - Follow-up week | 83.3 score | Standard Deviation 15.34 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Bodily Pain - End of treatment | 65.1 score | Standard Deviation 24.89 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Mental Component Score - End of treatment | 45.3 score | Standard Deviation 10.68 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Bodily Pain - Follow-up week | 76.7 score | Standard Deviation 24.33 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Mental Health - Baseline | 76.4 score | Standard Deviation 16.89 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | General Health - Baseline | 67.7 score | Standard Deviation 21.44 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Mental Component Score - Follow-up week | 54.8 score | Standard Deviation 8.49 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | General Health - End of treatment | 65.9 score | Standard Deviation 21.93 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Physical Component Score - baseline | 44.6 score | Standard Deviation 12.58 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | General Health - Follow-up week | 74.6 score | Standard Deviation 18.28 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Physical Functioning - Baseline | 76.1 score | Standard Deviation 29.27 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Vitality - Baseline | 57.5 score | Standard Deviation 23.75 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Emotional Role Functioning - Follow-up week | 85.6 score | Standard Deviation 31.66 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Vitality - End of treatment | 44.6 score | Standard Deviation 25.55 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Physical Functioning - End of treatment | 68.3 score | Standard Deviation 26.45 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Vitality - Follow-up week | 71.7 score | Standard Deviation 20.37 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Physical Component Score - End of treatment | 42.9 score | Standard Deviation 10.38 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Social Functioning - Baseline | 82.4 score | Standard Deviation 24.21 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Physical Functioning - Follow-up week | 84.2 score | Standard Deviation 24.35 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Social Functioning - End of treatment | 66.0 score | Standard Deviation 26.35 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Mental Health - End of treatment | 69.5 score | Standard Deviation 19.61 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Social Functioning - Follow-up week | 89.8 score | Standard Deviation 16.89 |
| Group A - HCEE | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Emotional Role Functioning - Baseline | 86.6 score | Standard Deviation 28.75 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Social Functioning - Follow-up week | 87.2 score | Standard Deviation 18.04 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Emotional Role Functioning - Baseline | 80.3 score | Standard Deviation 34.18 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Emotional Role Functioning - End of treatment | 64.2 score | Standard Deviation 42.76 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Emotional Role Functioning - Follow-up week | 82.0 score | Standard Deviation 32.01 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Mental Health - Baseline | 76.6 score | Standard Deviation 18.45 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Mental Health - End of treatment | 68.5 score | Standard Deviation 17.36 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Mental Health - Follow-up week | 77.2 score | Standard Deviation 15.74 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Physical Component Score - baseline | 45.5 score | Standard Deviation 11.8 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Physical Component Score - End of treatment | 43.7 score | Standard Deviation 9.21 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Physical Component Score - Follow-up week | 49.4 score | Standard Deviation 11.34 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Mental Component Score - Baseline | 51.4 score | Standard Deviation 9.08 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Mental Component Score - End of treatment | 45.2 score | Standard Deviation 10.05 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Mental Component Score - Follow-up week | 51.9 score | Standard Deviation 8.44 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Physical Functioning - Baseline | 77.1 score | Standard Deviation 26.23 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Physical Functioning - End of treatment | 70.3 score | Standard Deviation 24 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Physical Functioning - Follow-up week | 82.3 score | Standard Deviation 24.19 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Physical Role Functioning - Baseline | 68.0 score | Standard Deviation 41.22 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Physical Role Functioning - End of treatment | 47.0 score | Standard Deviation 42.76 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Physical Role Functioning - Follow-up week | 81.8 score | Standard Deviation 33.67 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Bodily Pain - Baseline | 68.9 score | Standard Deviation 29.02 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Bodily Pain - End of treatment | 66.0 score | Standard Deviation 22.04 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Bodily Pain - Follow-up week | 73.8 score | Standard Deviation 27.6 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | General Health - Baseline | 65.7 score | Standard Deviation 23.42 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | General Health - End of treatment | 69.0 score | Standard Deviation 20.05 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | General Health - Follow-up week | 74.0 score | Standard Deviation 19.24 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Vitality - Baseline | 58.2 score | Standard Deviation 23.12 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Vitality - End of treatment | 43.0 score | Standard Deviation 23.61 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Vitality - Follow-up week | 65.7 score | Standard Deviation 18.86 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Social Functioning - Baseline | 82.8 score | Standard Deviation 24.7 |
| Group B - Community Sites | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | Social Functioning - End of treatment | 67.9 score | Standard Deviation 25.86 |