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| ID | Type | Description | Link |
|---|---|---|---|
| 15BB-1301 | Other Grant/Funding Number | California Breast Cancer Research Program |
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| Name | Class |
|---|---|
| California Breast Cancer Research Program | OTHER |
| Circulo de Vida Cancer Support and Resource Center | OTHER |
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The purpose of this study is to test whether a new program Nuevo Amanecer (A New Dawn), improves the quality of life of Latinas diagnosed with breast cancer. Trained Latina counselors who have had breast cancer provide support to recently diagnosed women. The investigators call these counselors peer support counselors.
This study will assess the effectiveness of a cognitive-behavioral stress management (CBSM) intervention for newly diagnosed Latina breast cancer patients. In our prior work, the investigators established the appropriate content of the intervention, the need for early intervention, and the value of culturally competent peer support. In this study the investigators will adapt an evidence-based CBSM intervention designed to meet these needs. This study will use a randomized controlled trial (RCT) design with a wait-listed usual care control group to adapt the intervention and test its effectiveness in improving breast cancer specific quality-of-life, and decreasing anxiety and breast cancer specific distress. The new, adapted intervention will be called "Nuevo Amanecer" (A New Dawn).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer Support Program | Experimental | Nuevo Amanecer is the peer support program. Participants receive the peer support program as soon as possible after randomization. |
|
| Wait-list Control | No Intervention | Waits six months, and at the end of the six months is offered the option of participating in the peer support program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Support Program | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: physical well-being subscale. Of 7 items, 1 was dropped because it was conceptually different from other items on that scale. Modified subscale was scored by summing items. Possible score ranges for physical well-being were 0-24. Higher scores indicated greater well-being. | Baseline and 6 month assessment |
| Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: social/family well-being subscale. Of 7 items, 2 were dropped because the items were conditional on having a partner (resulting in lots of missing data). Modified subscale was scored by summing items. Possible score ranges for social/family well-being were 0-20. Higher scores indicated greater well-being. | Baseline and 6 month assessment |
| Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: emotional well-being subscale. Of 6 items, 1 was dropped because of low item-scale correlations and it was conceptually different from the other items on that scale (only positively worded item on the scale). Modified subscale was scored by summing items. Possible score ranges for emotional well-being were 0-20. Higher scores indicated greater well-being. |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety a Subscale of the Brief Symptom Inventory (BSI) | BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for anxiety were 0-4. Higher scores indicated more distress. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Gregorich, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | California | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34998436 | Derived | Bonilla J, Alhomsi A, Santoyo-Olsson J, Stewart AL, Ortiz C, Samayoa C, Torres-Nguyen A, Palomino H, Coleman V, Urias A, Gonzalez N, Cervantes SA, Duron Y, Napoles AM. Sharing research results with Latina breast cancer survivors who participated in a community-engaged behavioral RCT study: a descriptive cross-sectional survey study. Trials. 2022 Jan 8;23(1):25. doi: 10.1186/s13063-021-05945-8. | |
| 33937611 |
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Participants were recruited from February 2011 through November 2013 via flyers and word of mouth at clinics in five Northern California counties by community recruiters.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nuevo Amanecer Peer Support Program | Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship. Peer Support Program:
|
| FG001 | Wait-list Control | Waits six months, and at the end of the six months is offered the option of participating in the peer support program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Assessment |
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| 3 Month Assessment |
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| 6 Month Assessment |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nuevo Amanecer Peer Support Program | Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship. Peer Support Program:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: physical well-being subscale. Of 7 items, 1 was dropped because it was conceptually different from other items on that scale. Modified subscale was scored by summing items. Possible score ranges for physical well-being were 0-24. Higher scores indicated greater well-being. | Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 month assessment |
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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 | Nuevo Amanecer Peer Support Program | Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship. Peer Support Program:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anna Maria Napoles | University of California San Francisco | 415-476-6290 | anapoles@ucsf.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
|
| Baseline and 6 month assessment |
| Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: breast cancer concerns subscale. Of 7 items, 2 were dropped because of low item-scale correlations and were conceptually different from the other items on that scale. Modified subscale was scored by summing items. Possible score ranges for emotional well-being were 0-28. Higher scores indicated greater well-being. | Baseline and 6 month assessment |
| Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: functional well-being subscale. Of 7 items, 3 were dropped because items were conceptually different and did not converge psychometrically with the other items on that scale; the remaining 4 items were specific to enjoyment of life, thus we renamed the subscale to "Enjoyment of Life". Modified subscale was scored by summing items. Possible score ranges for enjoyment of life were 0-16. Higher scores indicated greater well-being. | Baseline and 6 month assessment |
| Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to each of the FACT-B subscale. The total overall score is based on the sum of modified subscales (see above primary outcomes for modifications to subscales). Possible score ranges for the total overall score were 0-108. Higher scores indicated greater well-being. | Baseline and 6 month assessment |
| Baseline and 6 month assessment |
| Depression a Subscale of the Brief Symptom Inventory (BSI) | BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for depression were 0-4. Higher scores indicated more distress. | Baseline and 6 month assessment |
| Somatization a Subscale of the Brief Symptom Inventory (BSI) | BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for somatization were 0-4. Higher scores indicated more distress. | Baseline and 6 month assessment |
| Breast Cancer-Specific Distress of the Intrusive Thoughts Scale | Breast cancer-specific distress was measured with the 7 item Intrusive Thoughts Scale (anchored to the breast cancer experience), a subscale of the revised Impact of Event Scale (RIES). Response options were 0=not at all, 1=rarely, 2=sometimes, and 3=often. Using the published scoring algorithm, items were summed after recoding responses to 0, 1, 3, and 5. Possible score ranges were 0-35. Higher scores indicate greater distress. | Baseline and 6 month assessment |
| Derived |
| Chacon L, Santoyo-Olsson J, Samayoa C, Alhomsi A, Stewart AL, Ortiz C, Escalera C, Napoles AM. Self-Efficacy for Coping with Breast Cancer Treatment Among Spanish-Speaking Latinas. Health Equity. 2021 Apr 26;5(1):245-252. doi: 10.1089/heq.2020.0152. eCollection 2021. |
| 33563263 | Derived | Bonilla J, Escalera C, Santoyo-Olsson J, Samayoa C, Ortiz C, Stewart AL, Napoles AM. The importance of patient engagement to quality of breast cancer care and health-related quality of life: a cross-sectional study among Latina breast cancer survivors in rural and urban communities. BMC Womens Health. 2021 Feb 9;21(1):59. doi: 10.1186/s12905-021-01200-z. |
| 28275966 | Derived | Napoles AM, Santoyo-Olsson J, Stewart AL, Ortiz C, Garcia-Jimenez M. Evaluating the Implementation of a Translational Peer-Delivered Stress Management Program for Spanish-Speaking Latina Breast Cancer Survivors. J Cancer Educ. 2018 Aug;33(4):875-884. doi: 10.1007/s13187-017-1202-y. |
| 25905829 | Derived | Napoles AM, Ortiz C, Santoyo-Olsson J, Stewart AL, Gregorich S, Lee HE, Duron Y, McGuire P, Luce J. Nuevo Amanecer: results of a randomized controlled trial of a community-based, peer-delivered stress management intervention to improve quality of life in Latinas with breast cancer. Am J Public Health. 2015 Jul;105 Suppl 3(0 3):e55-63. doi: 10.2105/AJPH.2015.302598. Epub 2015 Apr 23. |
| 24577971 | Derived | Napoles AM, Santoyo-Olsson J, Ortiz C, Gregorich S, Lee HE, Duron Y, Graves K, Luce JA, McGuire P, Diaz-Mendez M, Stewart AL. Randomized controlled trial of Nuevo Amanecer: a peer-delivered stress management intervention for Spanish-speaking Latinas with breast cancer. Clin Trials. 2014 Apr;11(2):230-8. doi: 10.1177/1740774514521906. Epub 2014 Feb 26. |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Wait-list Control | Waits six months, and at the end of the six months is offered the option of participating in the peer support program. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Educational attainment | Number | participants |
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| Health insurance | Number | participants |
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| Breast cancer | Number | participants |
|
| Stage | Stage 0-Carcinoma in situ; Stage I, Stage II, and Stage III-Higher numbers indicate more extensive disease: Larger tumor size and/or spread of the cancer beyond the organ in which it first developed to nearby lymph nodes and/or tissues or organs adjacent to the location of the primary tumor | Number | participants |
|
| Surgery | Number | participants |
|
| Adjuvant treatment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Nuevo Amanecer Peer Support Program | Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship. Peer Support Program:
|
| OG001 | Wait-list Control | Waits six months, and at the end of the six months is offered the option of participating in the peer support program. |
|
|
|
| Secondary | Anxiety a Subscale of the Brief Symptom Inventory (BSI) | BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for anxiety were 0-4. Higher scores indicated more distress. | Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 month assessment |
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| Primary | Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: social/family well-being subscale. Of 7 items, 2 were dropped because the items were conditional on having a partner (resulting in lots of missing data). Modified subscale was scored by summing items. Possible score ranges for social/family well-being were 0-20. Higher scores indicated greater well-being. | Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 month assessment |
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| Primary | Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: emotional well-being subscale. Of 6 items, 1 was dropped because of low item-scale correlations and it was conceptually different from the other items on that scale (only positively worded item on the scale). Modified subscale was scored by summing items. Possible score ranges for emotional well-being were 0-20. Higher scores indicated greater well-being. | Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 month assessment |
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| Primary | Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: breast cancer concerns subscale. Of 7 items, 2 were dropped because of low item-scale correlations and were conceptually different from the other items on that scale. Modified subscale was scored by summing items. Possible score ranges for emotional well-being were 0-28. Higher scores indicated greater well-being. | Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 month assessment |
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| Primary | Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: functional well-being subscale. Of 7 items, 3 were dropped because items were conceptually different and did not converge psychometrically with the other items on that scale; the remaining 4 items were specific to enjoyment of life, thus we renamed the subscale to "Enjoyment of Life". Modified subscale was scored by summing items. Possible score ranges for enjoyment of life were 0-16. Higher scores indicated greater well-being. | Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 month assessment |
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| Primary | Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to each of the FACT-B subscale. The total overall score is based on the sum of modified subscales (see above primary outcomes for modifications to subscales). Possible score ranges for the total overall score were 0-108. Higher scores indicated greater well-being. | Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 month assessment |
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| Secondary | Depression a Subscale of the Brief Symptom Inventory (BSI) | BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for depression were 0-4. Higher scores indicated more distress. | Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 month assessment |
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| Secondary | Somatization a Subscale of the Brief Symptom Inventory (BSI) | BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for somatization were 0-4. Higher scores indicated more distress. | Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 month assessment |
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| Secondary | Breast Cancer-Specific Distress of the Intrusive Thoughts Scale | Breast cancer-specific distress was measured with the 7 item Intrusive Thoughts Scale (anchored to the breast cancer experience), a subscale of the revised Impact of Event Scale (RIES). Response options were 0=not at all, 1=rarely, 2=sometimes, and 3=often. Using the published scoring algorithm, items were summed after recoding responses to 0, 1, 3, and 5. Possible score ranges were 0-35. Higher scores indicate greater distress. | Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 month assessment |
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|
| 0 |
| 76 |
| 0 |
| 76 |
| EG001 | Wait-list Control | Waits six months, and at the end of the six months is offered the option of participating in the peer support program. | 0 | 75 | 0 | 75 |
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |