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| ID | Type | Description | Link |
|---|---|---|---|
| STU00203197 | Other Identifier | Northwestern ID | |
| 1R01CA206456-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Northwestern University | OTHER |
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to look at the effects of a 10-week stress management in-person group program. The program will study emotions, stress, and stress management techniques (such as relaxation and coping techniques) on quality of life, distress, depression, and physical health in Spanish- speaking, Hispanic/Latino men diagnosed with Prostate Cancer (PC).
This 5-year study evaluates the effects of a 10-week group-based linguistically translated and culturally adapted cognitive-behavioral stress and self-management (C-CBSM) intervention on symptom burden and health related quality of life (HRQoL) in Hispanic men treated for localized prostate cancer (PC). About 80% PC cases are diagnosed as early disease and have a 5- and 10-year survival rate of almost 100% and 99%, respectively.1 Most patients receive active treatment (~70%) leading to prolonged treatment-related side effects and dysfunction persisting well beyond primary treatment. Survival is offset by chronic side effects such as sexual and urinary dysfunction, pain and fatigue that can lead to poor psychosocial functioning, impaired intimacy and social functioning, and masculinity concerns. Hispanic PC survivors report lower physical and social functioning, poorer emotional well-being and greater sexual and urinary dysfunction, even after accounting for SES and disease severity. These sequelae can lead to elevated glucocorticoid release and inflammatory cytokines that have a direct effect on these symptoms and can interfere with physiological pathways necessary for recovery of sexual and urinary functioning. We have shown that CBSM reduces symptom burden and improves HRQoL in bilingual Hispanic PC survivors. In a pilot we showed that a linguistic translation of CBSM with attention to sociocultural processes improved symptom burden and HRQoL in Spanish monolingual PC survivors. We have also shown that CBSM is associated with reduced glucocorticoid resistance and inflammatory gene expression pathways in circulating leukocytes among breast cancer survivors. We propose to (a) deliver a culturally adapted C-CBSM intervention in Spanish that places greater emphasis on salient sociocultural determinants of symptom burden and HRQoL in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo), (b) incorporate a neuroimmune model of symptom regulation and management, and (c) test the efficacy of C-CBSM, relative to standard non-culturally adapted CBSM, in two diverse Hispanic communities (Chicago & Miami). We will test our aims in 200 Hispanic men post-treatment for localized PC with elevated symptom burden in a 2 x 4 randomized design with condition (C-CSBM vs. CBSM) as the between groups factors, and time (baseline, post-intervention & 6- and 12-months post intervention) as the within groups factor.
Our Primary Aim is to determine whether randomization to C-CBSM, relative to standard CBSM, is associated with reduced symptom burden and improved HRQoL. Our Secondary Aims evaluate whether C-CBSM leads to greater improvements in the intervention targets (e.g., stress management, psychological distress & interpersonal disruption), and physiologic adaptation (i.e., glucocorticoid receptor sensitivity & inflammatory gene expression). We will also evaluate psychosocial and physiological mechanisms as mediators of C-CBSM's effects on our primary outcomes. We also explore several moderators (e.g., SES, acculturation, treatment, Hispanic origin) of CCBSM's effect on primary outcomes and the effects of C-CBSM on cardiometabolic health (e.g., lipids, fasting glucose) via reduced inflammation.
Primary Aim:
Aim 1: Determine whether participation in C-CBSM is associated with significantly greater reductions in symptom burden and improvements in HRQoL relative to participation in CBSM.
Secondary Aims:
Aim 2: Determine whether participation in C-CBSM is associated with significantly greater improvements in intervention targets (i.e., improved stress management, and reduced psychological distress and interpersonal disruption) relative to participation in the CBSM condition.
Exploratory Aims:
Aim 3: Explore whether participation in C-CBSM is associated with significantly greater activation of leukocyte glucocorticoid receptor and less inflammatory gene expression profiles relative to CBSM.
Aim 4: Explore whether C-CBSM related improvements in symptom burden and HRQoL are mediated by improvements in intervention targets and gene expression profiles.
Aim 5: Explore moderators of C-CBSM (e.g., SES, treatment type, acculturation, Hispanic ancestry) and CCBSM's effects on cardiometabolic markers via reduced inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cultural-Cognitive Behavioral Stress Management (CCBSM) | Experimental | Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention. |
|
| Cognitive Behavioral Stress Management (CBSM) | Active Comparator | Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cultural CBSM | Behavioral | The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Symptom Burden as Measure by EPIC-S. | Symptom Burden will be measured using the 5-item sexual domain of the Expanded Prostate Cancer Index Composite (EPIC) - Short Form (EPIC-S). All items are transformed to a 0-100 scale and averaged to calculate the domain summary scores, where higher scores indicate better functioning and less bother. | Baseline, Month 3, Month 6, Month 12 |
| Change in HRQoL as Measured by the FACT Questionnaire. | HRQoL will be measured using Functional Assessment of Cancer Therapy - Prostate (FACT-P) including 4 domains of the FACT-General (FACT-G). The questionnaire has 39 items, with the total score ranging from 0-156. Higher scores indicate better function. | Baseline, Month 3, Month 6, Month 12 |
| Change in Symptom Burden as Measure by EPIC-UIN. | Symptom Burden will be measured using the 9-item urinary domain of the Expanded Prostate Cancer Index Composite (EPIC) - Short Form (EPIC-UIN). All items are transformed to a 0-100 scale and averaged to calculate the domain summary scores, where higher scores indicate better functioning and less bother. | Baseline, Month 3, Month 6, Month 12 |
| Change in HRQoL as Measured by the PROMIS Fatigue Questionnaire | HRQoL will be measured using Patient-Reported Outcome Measurement Information System (PROMIS) short form for Fatigue Questionnaire. The PROMIS Fatigue measure generates t-scores with a mean of 50 and a standard deviation of 10. Scores typically range from approximately 30 to 80. Higher scores indicate greater fatigue. | Baseline, Month 3, Month 6, Month 12 |
| Change in HRQoL as Measured by the PROMIS Pain Questionnaire | HRQoL will be measured using the PROMIS short form for Pain Interference Questionnaire. The items are item banks, and scoring is done via a computer adaptive test (CAT), which utilizes item response theory (IRT) to calculate a score that is then transformed into a T-score with a mean of 50 and a standard deviation of 10. Scores typically range from approximately 30 to 80. Items are administered in an iterative approach where subsequent items are calibrated on prior ones. Once standard error reaches 2 or less, the CAT stops administering items. Higher scores indicate greater pain interference. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Stress Management Skills as Measured by MOCS-A | Stress management skills will be measured using the Measure of Current Status Part A (MOCS-A) Questionnaire. MOCS-A is a 13-item questionnaire with a total score ranging from 0 - 52 with the higher score indicating greater stress management skills. | Baseline, Month 3, Month 6, Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
History of non-skin cancer within the last 2 years.
Prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) within the past six months, as these conditions can interfere with adequate participation in our experimental conditions may be exclusionary, per P.I. discretion, based on a case-by-case review;
Active alcohol dependence within the past six months may be exclusionary, per P.I. discretion, based on a case-by-case review;
Active substance dependence within the past six months may be exclusionary, per P.I. discretion, based on a case-by-case review; and
Acute or chronic immune system medical conditions, medications or conditions that impact immune and endocrine function (e.g., Chronic Fatigue Syndrome (CFS), Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions), per PI discretion based on a case by case review.
Individuals scoring >3 on the SPMSQ will be excluded or per PI discretion based on a case by case review.
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| Name | Affiliation | Role |
|---|---|---|
| Frank Penedo, Ph.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States | ||
| Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38429598 | Derived | Pedreira PB, Fleszar-Pavlovic SE, Walsh EA, Noriega Esquives B, Moreno PI, Perdomo D, Heller AS, Antoni MH, Penedo FJ. Familism, family cohesion, and health-related quality of life in Hispanic prostate cancer survivors. J Behav Med. 2024 Aug;47(4):595-608. doi: 10.1007/s10865-024-00479-1. Epub 2024 Mar 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cultural-Cognitive Behavioral Stress Management (CCBSM) | Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention. Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo). |
| FG001 | Cognitive Behavioral Stress Management (CBSM) | Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention. Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cultural-Cognitive Behavioral Stress Management (CCBSM) | Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention. Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo). |
| 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 | Change in Symptom Burden as Measure by EPIC-S. | Symptom Burden will be measured using the 5-item sexual domain of the Expanded Prostate Cancer Index Composite (EPIC) - Short Form (EPIC-S). All items are transformed to a 0-100 scale and averaged to calculate the domain summary scores, where higher scores indicate better functioning and less bother. | Not all participants completed every assessment/timepoint and some were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, Month 3, Month 6, Month 12 |
|
1 year
Grade 1 Mild; asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated Grade 5 Death related to AE
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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 | Cultural-Cognitive Behavioral Stress Management (CCBSM) | Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention. Cultural CBSM: The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injury | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frank Penedo | University of Miami | 305-284-4290 | fpenedo@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 14, 2025 | Aug 14, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 17, 2022 | Apr 23, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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|
| Standard CBSM | Behavioral | The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. |
|
| Baseline, Month 3, Month 6, Month 12 |
| Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section I-II | Psychological distress will be measured using the Memorial Anxiety Scale for Prostate Cancer Patients (MAX-PC) Questionnaire. The MAX-PC sections I-II is a 14-item questionnaire with a total score ranging from 0-42 with the higher score indicating increased distress. | Baseline, Month 3, Month 6, Month 12 |
| Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section III | Psychological distress will be measured using the Memorial Anxiety Scale for Prostate Cancer Patients (MAX-PC) Questionnaire. The MAX-PC section III is a 4-item questionnaire with a total score ranging from 0-12 with the lower score indicating increased distress. | Baseline, Month 3, Month 6, Month 12 |
| Change in Psychosocial Distress as Measured by the PROMIS Depression Questionnaire | PROMIS-Depression is a 28-item questionnaire with a total score ranging from 28-140 with the higher score indicating increased symptoms of depression. | Baseline, Month 3, Month 6, Month 12 |
| Change in Psychosocial Distress as Measured by the PROMIS Anxiety Questionnaire | PROMIS-Anxiety is a 29-item questionnaire with a total score ranging from 29-145 with the higher score indicating increased symptoms of anxiety. | Baseline, Month 3, Month 6, Month 12 |
| Change in Interpersonal Function as Measured the SIP Questionnaire | Sickness Impact Profile (SIP) is a 20-item questionnaire responded with a yes or no. The total number of yes responses will be scored as 1 point with the total score ranging from 0-20 with the higher score indicating poor interpersonal function. | Baseline, Month 3, Month 6, Month 12 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| BG001 | Cognitive Behavioral Stress Management (CBSM) | Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention. Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Cognitive Behavioral Stress Management (CBSM) | Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention. Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. |
|
|
| Primary | Change in HRQoL as Measured by the FACT Questionnaire. | HRQoL will be measured using Functional Assessment of Cancer Therapy - Prostate (FACT-P) including 4 domains of the FACT-General (FACT-G). The questionnaire has 39 items, with the total score ranging from 0-156. Higher scores indicate better function. | Not all participants completed every assessment/timepoint and some were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, Month 3, Month 6, Month 12 |
|
|
|
| Primary | Change in Symptom Burden as Measure by EPIC-UIN. | Symptom Burden will be measured using the 9-item urinary domain of the Expanded Prostate Cancer Index Composite (EPIC) - Short Form (EPIC-UIN). All items are transformed to a 0-100 scale and averaged to calculate the domain summary scores, where higher scores indicate better functioning and less bother. | Not all participants completed every assessment/timepoint and some were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, Month 3, Month 6, Month 12 |
|
|
|
| Primary | Change in HRQoL as Measured by the PROMIS Fatigue Questionnaire | HRQoL will be measured using Patient-Reported Outcome Measurement Information System (PROMIS) short form for Fatigue Questionnaire. The PROMIS Fatigue measure generates t-scores with a mean of 50 and a standard deviation of 10. Scores typically range from approximately 30 to 80. Higher scores indicate greater fatigue. | Not all participants completed every assessment/timepoint and some were lost to follow-up. | Posted | Mean | Standard Error | T-score | Baseline, Month 3, Month 6, Month 12 |
|
|
|
| Primary | Change in HRQoL as Measured by the PROMIS Pain Questionnaire | HRQoL will be measured using the PROMIS short form for Pain Interference Questionnaire. The items are item banks, and scoring is done via a computer adaptive test (CAT), which utilizes item response theory (IRT) to calculate a score that is then transformed into a T-score with a mean of 50 and a standard deviation of 10. Scores typically range from approximately 30 to 80. Items are administered in an iterative approach where subsequent items are calibrated on prior ones. Once standard error reaches 2 or less, the CAT stops administering items. Higher scores indicate greater pain interference. | Not all participants completed every assessment/timepoint and some were lost to follow-up. | Posted | Mean | Standard Error | T-score | Baseline, Month 3, Month 6, Month 12 |
|
|
|
| Secondary | Change in Stress Management Skills as Measured by MOCS-A | Stress management skills will be measured using the Measure of Current Status Part A (MOCS-A) Questionnaire. MOCS-A is a 13-item questionnaire with a total score ranging from 0 - 52 with the higher score indicating greater stress management skills. | Not all participants completed every assessment/timepoint and some were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, Month 3, Month 6, Month 12 |
|
|
|
| Secondary | Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section I-II | Psychological distress will be measured using the Memorial Anxiety Scale for Prostate Cancer Patients (MAX-PC) Questionnaire. The MAX-PC sections I-II is a 14-item questionnaire with a total score ranging from 0-42 with the higher score indicating increased distress. | Not all participants completed every assessment/timepoint and some were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, Month 3, Month 6, Month 12 |
|
|
|
| Secondary | Change in Prostate Cancer-specific Psychological Distress as Measured by MAX-PC - Section III | Psychological distress will be measured using the Memorial Anxiety Scale for Prostate Cancer Patients (MAX-PC) Questionnaire. The MAX-PC section III is a 4-item questionnaire with a total score ranging from 0-12 with the lower score indicating increased distress. | Not all participants completed every assessment/timepoint and some were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, Month 3, Month 6, Month 12 |
|
|
|
| Secondary | Change in Psychosocial Distress as Measured by the PROMIS Depression Questionnaire | PROMIS-Depression is a 28-item questionnaire with a total score ranging from 28-140 with the higher score indicating increased symptoms of depression. | Not all participants completed every assessment/timepoint and some were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, Month 3, Month 6, Month 12 |
|
|
|
| Secondary | Change in Psychosocial Distress as Measured by the PROMIS Anxiety Questionnaire | PROMIS-Anxiety is a 29-item questionnaire with a total score ranging from 29-145 with the higher score indicating increased symptoms of anxiety. | Not all participants completed every assessment/timepoint and some were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, Month 3, Month 6, Month 12 |
|
|
|
| Secondary | Change in Interpersonal Function as Measured the SIP Questionnaire | Sickness Impact Profile (SIP) is a 20-item questionnaire responded with a yes or no. The total number of yes responses will be scored as 1 point with the total score ranging from 0-20 with the higher score indicating poor interpersonal function. | Not all participants completed every assessment/timepoint and some were lost to follow-up. | Posted | Mean | Standard Error | score on a scale | Baseline, Month 3, Month 6, Month 12 |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 3 |
| 100 |
| EG001 | Cognitive Behavioral Stress Management (CBSM) | Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention. Standard CBSM: The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. | 0 | 88 | 3 | 88 | 7 | 88 |
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
|
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| D052801 |
| Male Urogenital Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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