| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00564 | Registry Identifier | Clinical Trials Reporting Program (CTRP) | |
| R01CA126857 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Yoga may improve inflammation, fatigue, and depression in female breast cancer survivors.
PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving physical activity, inflammation, fatigue, and distress in female breast cancer survivors.
OBJECTIVES:
Primary
OUTLINE: Patients are stratified according to stage of cancer (stage 0 vs stage I vs stage II and stage IIIA) and prior radiation therapy (yes vs no). Patients are randomized to 1 of 2 intervention arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I: Yoga Therapy | Experimental | Patients participate in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients are also encouraged to practice yoga at home using the appropriate DVD/video segments for the month. |
|
| Arm II: Wait-List | No Intervention | Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga Therapy | Procedure | Patients will undergo yoga therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stimulated ln (TNF-a) | log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha) | Immediately post-treatment and 3 months post-treatment |
| Stimulated ln (IL-6) | log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6) | Immediately post-treatment and 3 months post-treatment |
| Stimulated ln (IL-1b) | log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b) | Immediately post-treatment and 3 months post-treatment |
| MFSI-SF Fatigue | The 30-item Multidimensional Fatigue Symptom Inventory-Short form (MFSI-SF) assesses behavioral, cognitive, physical, and affective expressions of fatigue. Items are rated on a 5-point scale indicating how true each statement was for the respondent during the last week (0=not at all; 4=extremely). The total score represents the sum of the subscales measuring general, physical, emotional, and mental fatigue, minus the vigor scale, providing a possible range of scores from -24 to 96, with higher scores indicating greater fatigue. | Immediately post-treatment and 3 months post-treatment |
| Vitality, SF-36 | The SF-36's (RAND Health Survey) energy/fatigue (vitality) scale focuses on the frequency of feelings of fatigue over the last month. Standardized scores on the RAND SF-36 vigor/vitality scale range from 0-100, with higher scores indicating less fatigue. | Immediately post-treatment and 3 months post-treatment |
| CES-D | The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale. Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms. |
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DISEASE CHARACTERISTICS:
Stage 0-IIIA breast cancer survivor
Completed cancer treatment within the past 36 months (except for tamoxifen/aromatase inhibitors)
Women who are not currently practicing yoga and have not participated in any of the following activities:
Women who typically engage in a total of 5 or more hours of vigorous physical activity per week are not eligible
No inflammatory breast cancer
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Inability to comfortably get up and down from the floor 2-3 times in a session
Breathing problems requiring use of oxygen
Problems walking without a cane or walker assistance
Prior knee or hip replacement with limited movement in the joint
Inability to comfortably lie on the stomach
Alcohol, or drug abuse
Diagnosis of any of the following conditions:
History of breast or any other cancer, except basal or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Janice Kiecolt-Glaser, PhD | Ohio State University Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210-1240 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24470004 | Result | Kiecolt-Glaser JK, Bennett JM, Andridge R, Peng J, Shapiro CL, Malarkey WB, Emery CF, Layman R, Mrozek EE, Glaser R. Yoga's impact on inflammation, mood, and fatigue in breast cancer survivors: a randomized controlled trial. J Clin Oncol. 2014 Apr 1;32(10):1040-9. doi: 10.1200/JCO.2013.51.8860. Epub 2014 Jan 27. |
| Label | URL |
|---|---|
| The Jamesline | View source |
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We assessed functional limitations during the screening session. Those who had mobility/functional limitations were dropped out before randomization.
We enrolled a sample of 200 breast cancer survivors with respect to age, stage of cancer, and treatment modalities between October 2007 and April 2012 in the Ohio State University Medical Center. Women were recruited through oncologists' referrals, community print and web-based announcements, and breast cancer groups and events.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I: Yoga Therapy | Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs. |
| FG001 | Arm II: Wait-List | Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I: Yoga Therapy | Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs. |
| BG001 | Arm II: Wait-List |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stimulated ln (TNF-a) | log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha) | Any subjects who do not have any measurements post-baseline are excluded from analyses. | Posted | Least Squares Mean | Standard Error | ln (pg/mL) | Immediately post-treatment and 3 months post-treatment |
|
Post-intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I: Yoga Therapy | Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recurrence of chronic back and/or shoulder problems | Musculoskeletal and connective tissue disorders |
We did not compare yoga to an active control group; Fatigue and depressive symptoms were not used as part of the inclusion criteria. Accordingly, our data may underestimate yoga's potential benefit.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janice Kiecolt-Glaser, Principal Investigator | Ohio State University Comprehensive Cancer Center | 614-293-3499 | Janice.Kiecolt-Glaser@osumc.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003863 | Depression |
| D005221 | Fatigue |
| D010146 | Pain |
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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| Immediately post-treatment and 3 months post-treatment |
Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| SAD | Sagittal Abdominal Diameter | Mean | Standard Deviation | cm |
|
| Ethnicity | Number | participants |
|
| CES-D depressive symptoms | The Center for Epidemiological Studies Depression Scale (CES-D) has been used extensively to measure depressive symptomatology. Each of the 20 items are rated on a four-point scale, yielding a total score that can range from 0 to 60. Higher values represent more depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| Usage of Cardiac Medication | Number | participants |
|
| CHAMPS activity | The Community Health Activities Model Program for Seniors questionnaire (CHAMPS) assessed the weekly frequency and duration of various physical activities. | Mean | Standard Deviation | total hours/week |
|
| MFSI-SF Fatigue | The 30-item Multidimensional Fatigue Symptom Inventory-Short form (MFSI-SF) assesses behavioral, cognitive, physical, and affective expressions of fatigue. Items are rated on a 5-point scale indicating how true each statement was for the respondent during the last week (0=not at all; 4=extremely). The total score represents the sum of the subscales measuring general, physical, emotional, and mental fatigue, minus the vigor scale, providing a possible range of scores from -24 to 96, with higher scores indicating greater fatigue. | Mean | Standard Deviation | units on a scale |
|
| SF-36 Vitality | The SF-36's (RAND Health Survey) energy/fatigue (vitality) scale focuses on the frequency of feelings of fatigue over the last month. Standardized scores on the RAND SF-36 vigor/vitality scale range from 0-100, with higher scores indicating less fatigue. | Mean | Standard Deviation | units on a scale |
|
| Marital Status | Number | participants |
|
| Education level | Number | participants |
|
| Employment Status | Number | participants |
|
| Income level | Number | participants |
|
| Type of Treatment | Number | participants |
|
| Cancer Stage | Number | participants |
|
| HER2 Receptor Status | Number | participants |
|
| Progesterone Receptor Status | Number | participants |
|
| Estrogen Receptor Status | Number | participants |
|
| Usage of Tamoxifen/Aromatase Inhibitors | Number | participants |
|
| Post-menopausal | Number | participants |
|
| Time since diagnosis | Mean | Standard Deviation | months |
|
| Time since treatment | Mean | Standard Deviation | months |
|
|
|
|
| Primary | Stimulated ln (IL-6) | log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6) | Any subjects who do not have any measurements post-baseline are excluded from analyses. | Posted | Least Squares Mean | Standard Error | ln (pg/mL) | Immediately post-treatment and 3 months post-treatment |
|
|
|
|
| Primary | Stimulated ln (IL-1b) | log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b) | Any subjects who do not have any measurements post-baseline are excluded from analyses. | Posted | Least Squares Mean | Standard Error | ln (pg/mL) | Immediately post-treatment and 3 months post-treatment |
|
|
|
|
| Primary | MFSI-SF Fatigue | The 30-item Multidimensional Fatigue Symptom Inventory-Short form (MFSI-SF) assesses behavioral, cognitive, physical, and affective expressions of fatigue. Items are rated on a 5-point scale indicating how true each statement was for the respondent during the last week (0=not at all; 4=extremely). The total score represents the sum of the subscales measuring general, physical, emotional, and mental fatigue, minus the vigor scale, providing a possible range of scores from -24 to 96, with higher scores indicating greater fatigue. | Any subjects who do not have any measurements post-baseline are excluded from analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Immediately post-treatment and 3 months post-treatment |
|
|
|
|
| Primary | Vitality, SF-36 | The SF-36's (RAND Health Survey) energy/fatigue (vitality) scale focuses on the frequency of feelings of fatigue over the last month. Standardized scores on the RAND SF-36 vigor/vitality scale range from 0-100, with higher scores indicating less fatigue. | Any subjects who do not have any measurements post-baseline are excluded from analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Immediately post-treatment and 3 months post-treatment |
|
|
|
|
| Primary | CES-D | The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale. Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms. | Any subjects who do not have any measurements post-baseline are excluded from analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Immediately post-treatment and 3 months post-treatment |
|
|
|
|
| 0 |
| 100 |
| 2 |
| 100 |
| EG001 | Arm II: Wait-List | Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes. | 0 | 100 | 0 | 100 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
| No |
| Superiority or Other |
| Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm. | Mixed Models Analysis | The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates. | 0.015 | Mean Difference (Final Values) | -0.16 | Standard Error of the Mean | 0.064 | 2-Sided | 95 | -0.28 | -0.031 | Yoga minus Control 3 months post-treatment | No | Superiority or Other |
| Secondary analysis on change of ln (IL-6) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD. | Mixed Models Analysis | The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates. | 0.3 | Slope | -0.022 | Standard Error of the Mean | 0.021 | 2-Sided | 95 | -0.063 | 0.019 | Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment. | No | Superiority or Other |
| Secondary analysis on change of ln (IL-6) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD. | Mixed Models Analysis | The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates. | 0.01 | Slope | -0.056 | Standard Error of the Mean | 0.022 | 2-Sided | 95 | -0.098 | -0.013 | Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment. | No | Superiority or Other |
| No |
| Superiority or Other |
| Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm. | Mixed Models Analysis | The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates. | 0.037 | Mean Difference (Final Values) | -0.23 | Standard Error of the Mean | 0.11 | 2-Sided | 95 | -0.44 | -0.014 | Yoga minus Control 3 months post-treatment | No | Superiority or Other |
| Secondary analysis on change of ln (IL-1b) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD. | Mixed Models Analysis | The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates. | 0.33 | Slope | -0.034 | Standard Error of the Mean | 0.0235 | 2-Sided | 95 | -0.10 | 0.035 | Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment. | No | Superiority or Other |
| Secondary analysis on change of ln (IL-1b) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD. | Mixed Models Analysis | The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates. | 0.03 | Slope | -0.078 | Standard Error of the Mean | 0.036 | 2-Sided | 95 | -0.15 | -0.0074 | Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment. | No | Superiority or Other |
| No |
| Superiority or Other |
| Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm. | Mixed Models Analysis | The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates. | 0.002 | Mean Difference (Final Values) | -7.0 | Standard Error of the Mean | 2.2 | 2-Sided | 95 | -11.4 | -2.7 | Yoga minus Control 3 months post-treatment | No | Superiority or Other |
| Secondary analysis on change of MFSI-SF Fatigue for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD. | Mixed Models Analysis | The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates. | 0.019 | Slope | -1.7 | Standard Error of the Mean | 0.70 | 2-Sided | 95 | -3.1 | -0.28 | Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment. | No | Superiority or Other |
| Secondary analysis on change of MFSI-SF fatigue for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD. | Mixed Models Analysis | The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates. | 0.0001 | Slope | -2.8 | Standard Error of the Mean | 0.71 | 2-Sided | 95 | -4.2 | -1.4 | Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment. | No | Superiority or Other |
| No |
| Superiority or Other |
| Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm. | Mixed Models Analysis | The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates. | 0.01 | Mean Difference (Final Values) | 6.6 | Standard Error of the Mean | 2.5 | 2-Sided | 95 | 1.5 | 11.6 | Yoga minus Control 3 months post-treatment | No | Superiority or Other |
| Secondary analysis on change of vitality (SF-36) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD. | Mixed Models Analysis | The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates. | 0.016 | Slope | 2.1 | Standard Error of the Mean | 0.85 | 2-Sided | 95 | 0.40 | 3.75 | Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment. | No | Superiority or Other |
| Secondary analysis on change of vitality (SF-36) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD. | Mixed Models Analysis | The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates. | 0.0045 | Slope | 2.5 | Standard Error of the Mean | 0.85 | 2-Sided | 95 | 0.77 | 4.14 | Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment. | No | Superiority or Other |
| No |
| Superiority or Other |
| Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm. | Mixed Models Analysis | The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates. | 0.21 | Mean Difference (Final Values) | -1.3 | Standard Error of the Mean | 0.99 | 2-Sided | 95 | -3.2 | 0.69 | Yoga minus Control 3 months post-treatment | No | Superiority or Other |
| Secondary analysis on change of CES-D for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD. | Mixed Models Analysis | The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates. | 0.051 | Slope | -0.66 | Standard Error of the Mean | 0.34 | 2-Sided | 95 | -1.3 | 0.0039 | Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment. | No | Superiority or Other |
| Secondary analysis on change of CESD for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD. | Mixed Models Analysis | The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates. | 0.098 | Slope | -0.56 | Standard Error of the Mean | 0.34 | 2-Sided | 95 | -1.2 | 0.10 | Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment. | No | Superiority or Other |