Breast Neoplasms, Psychology, Social
Conditions
Keywords
Breast cancer, Latinas, Peer support counselor, Spanish speaking, Community based
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALPeer Support Program
* Work with a trained counselor who is a breast cancer survivor * Meet 8 times in-person over the 8 week program with the counselor * Counselor helps participant develop a personalized support program to help her improve her quality of life * Receives information on breast cancer, its treatments, and stress management
Sponsors
California Breast Cancer Research Program
Circulo de Vida Cancer Support and Resource Center
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Self-identifies as Latina * Diagnosed with Stage 0, I, II, or III in the prior month * Primarily Spanish-speaking, or Spanish monolingual * Aged 18 or older * Diagnosed in Alameda, Contra Costa, San Mateo, San Francisco or Santa Clara counties, California.
Exclusion criteria
* Previous cancer diagnosis except for non-melanoma skin cancer * Terminal illness * Stage IV breast cancer (distant metastasis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | Baseline and 6 month assessment | 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. |
| Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | Baseline and 6 month assessment | 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. |
| Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | Baseline and 6 month assessment | 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. |
| Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | Baseline and 6 month assessment | 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. |
| Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | Baseline and 6 month assessment | 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. |
| Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | Baseline and 6 month assessment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression a Subscale of the Brief Symptom Inventory (BSI) | Baseline and 6 month assessment | 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. |
| Somatization a Subscale of the Brief Symptom Inventory (BSI) | Baseline and 6 month assessment | 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. |
| Breast Cancer-Specific Distress of the Intrusive Thoughts Scale | Baseline and 6 month assessment | 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. |
| Anxiety a Subscale of the Brief Symptom Inventory (BSI) | Baseline and 6 month assessment | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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:
* Work with a trained counselor who is a breast cancer survivor
* Meet 8 times in-person over the 8 week program with the counselor
* Counselor helps participant develop a personalized support program to help her improve her quality of life
* Receives information on breast cancer, its treatments, stress management, and cognitive refraining. | 76 |
| 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. | 75 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3 Month Assessment | Death | 0 | 1 |
| 3 Month Assessment | Lost to Follow-up | 2 | 0 |
| 3 Month Assessment | Refused to complete | 4 | 0 |
| 6 Month Assessment | Lost to Follow-up | 1 | 1 |
| 6 Month Assessment | Refused to complete | 4 | 0 |
Baseline characteristics
| Characteristic | Nuevo Amanecer Peer Support Program | Total | Wait-list Control |
|---|---|---|---|
| Adjuvant treatment Both chemotherapy and radiation | 33 participants | 60 participants | 27 participants |
| Adjuvant treatment No treatment | 11 participants | 24 participants | 13 participants |
| Adjuvant treatment Only chemotherapy | 14 participants | 25 participants | 11 participants |
| Adjuvant treatment Only radiation | 18 participants | 42 participants | 24 participants |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 15 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 66 Participants | 136 Participants | 70 Participants |
| Age, Continuous | 50.8 years STANDARD_DEVIATION 11.9 | 50.5 years STANDARD_DEVIATION 10.9 | 50.2 years STANDARD_DEVIATION 9.9 |
| Breast cancer Ductal Carcinoma In Situ (DCIS) | 20 participants | 40 participants | 20 participants |
| Breast cancer Invasive | 56 participants | 111 participants | 55 participants |
| Educational attainment 6th grade to less than high school | 15 participants | 27 participants | 12 participants |
| Educational attainment High school graduate | 11 participants | 24 participants | 13 participants |
| Educational attainment Less than 6th grade | 50 participants | 100 participants | 50 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 76 Participants | 151 Participants | 75 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Health insurance Any private | 11 participants | 21 participants | 10 participants |
| Health insurance Missing data | 0 participants | 7 participants | 7 participants |
| Health insurance None | 3 participants | 5 participants | 2 participants |
| Health insurance Public insurance only | 62 participants | 118 participants | 56 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 76 Participants | 151 Participants | 75 Participants |
| Region of Enrollment United States | 76 participants | 151 participants | 75 participants |
| Sex: Female, Male Female | 76 Participants | 151 Participants | 75 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Stage 0 (in situ) | 20 participants | 40 participants | 20 participants |
| Stage I (1) | 12 participants | 23 participants | 11 participants |
| Stage II (2) | 31 participants | 57 participants | 26 participants |
| Stage III (3) | 13 participants | 31 participants | 18 participants |
| Surgery Breast conserving | 43 participants | 84 participants | 41 participants |
| Surgery Mastectomy | 33 participants | 67 participants | 34 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 76 | 0 / 75 |
| serious Total, serious adverse events | 0 / 76 | 0 / 75 |
Outcome results
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.
Time frame: Baseline and 6 month assessment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nuevo Amanecer Peer Support Program | Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | Baseline | 16.52 units on a scale | Standard Deviation 5.43 |
| Nuevo Amanecer Peer Support Program | Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | 6 month | 21.31 units on a scale | Standard Deviation 3.83 |
| Wait-list Control | Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | Baseline | 17.33 units on a scale | Standard Deviation 5.08 |
| Wait-list Control | Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | 6 month | 19.92 units on a scale | Standard Deviation 5.22 |
p-value: 0.013Mixed Models Analysis
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.
Time frame: Baseline and 6 month assessment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nuevo Amanecer Peer Support Program | Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | Baseline | 12.07 units on a scale | Standard Deviation 4.91 |
| Nuevo Amanecer Peer Support Program | Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | 6 month | 16.39 units on a scale | Standard Deviation 3.3 |
| Wait-list Control | Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | Baseline | 12.86 units on a scale | Standard Deviation 5.14 |
| Wait-list Control | Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | 6 month | 14.89 units on a scale | Standard Deviation 3.95 |
p-value: 0.004Mixed Models Analysis
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.
Time frame: Baseline and 6 month assessment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nuevo Amanecer Peer Support Program | Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | Baseline | 8.92 units on a scale | Standard Deviation 3.8 |
| Nuevo Amanecer Peer Support Program | Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | 6 month | 9.79 units on a scale | Standard Deviation 3.39 |
| Wait-list Control | Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | Baseline | 9.22 units on a scale | Standard Deviation 3.43 |
| Wait-list Control | Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | 6 month | 9.30 units on a scale | Standard Deviation 3.06 |
p-value: 0.267Mixed Models Analysis
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.
Time frame: Baseline and 6 month assessment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nuevo Amanecer Peer Support Program | Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | Baseline | 15.29 units on a scale | Standard Deviation 5.78 |
| Nuevo Amanecer Peer Support Program | Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | 6 month | 19.44 units on a scale | Standard Deviation 4.26 |
| Wait-list Control | Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | Baseline | 16.76 units on a scale | Standard Deviation 5.02 |
| Wait-list Control | Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | 6 month | 18.44 units on a scale | Standard Deviation 4.58 |
p-value: 0.015Mixed Models Analysis
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.
Time frame: Baseline and 6 month assessment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nuevo Amanecer Peer Support Program | Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | Baseline | 13.67 units on a scale | Standard Deviation 4.42 |
| Nuevo Amanecer Peer Support Program | Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | 6 month | 13.72 units on a scale | Standard Deviation 4.81 |
| Wait-list Control | Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | Baseline | 12.66 units on a scale | Standard Deviation 4.25 |
| Wait-list Control | Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | 6 month | 14.47 units on a scale | Standard Deviation 3.81 |
p-value: 0.025Mixed Models Analysis
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.
Time frame: Baseline and 6 month assessment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nuevo Amanecer Peer Support Program | Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | Baseline | 66.46 units on a scale | Standard Deviation 16.92 |
| Nuevo Amanecer Peer Support Program | Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | 6 month | 80.64 units on a scale | Standard Deviation 13.64 |
| Wait-list Control | Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | Baseline | 68.83 units on a scale | Standard Deviation 15.33 |
| Wait-list Control | Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) | 6 month | 77.02 units on a scale | Standard Deviation 15.62 |
p-value: 0.03Mixed Models Analysis
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.
Time frame: Baseline and 6 month assessment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nuevo Amanecer Peer Support Program | Anxiety a Subscale of the Brief Symptom Inventory (BSI) | Baseline | 0.93 units on a scale | Standard Deviation 0.84 |
| Nuevo Amanecer Peer Support Program | Anxiety a Subscale of the Brief Symptom Inventory (BSI) | 6 month | 0.39 units on a scale | Standard Deviation 0.53 |
| Wait-list Control | Anxiety a Subscale of the Brief Symptom Inventory (BSI) | Baseline | 1.01 units on a scale | Standard Deviation 0.88 |
| Wait-list Control | Anxiety a Subscale of the Brief Symptom Inventory (BSI) | 6 month | 0.58 units on a scale | Standard Deviation 0.76 |
p-value: 0.465Mixed Models Analysis
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.
Time frame: Baseline and 6 month assessment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nuevo Amanecer Peer Support Program | Breast Cancer-Specific Distress of the Intrusive Thoughts Scale | Baseline | 7.96 units on a scale | Standard Deviation 8.46 |
| Nuevo Amanecer Peer Support Program | Breast Cancer-Specific Distress of the Intrusive Thoughts Scale | 6 month | 3.87 units on a scale | Standard Deviation 5.79 |
| Wait-list Control | Breast Cancer-Specific Distress of the Intrusive Thoughts Scale | Baseline | 8.65 units on a scale | Standard Deviation 8.91 |
| Wait-list Control | Breast Cancer-Specific Distress of the Intrusive Thoughts Scale | 6 month | 6.27 units on a scale | Standard Deviation 8.42 |
p-value: 0.226Mixed Models Analysis
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.
Time frame: Baseline and 6 month assessment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nuevo Amanecer Peer Support Program | Depression a Subscale of the Brief Symptom Inventory (BSI) | 6 month | 0.38 units on a scale | Standard Deviation 0.48 |
| Nuevo Amanecer Peer Support Program | Depression a Subscale of the Brief Symptom Inventory (BSI) | Baseline | 0.93 units on a scale | Standard Deviation 0.84 |
| Wait-list Control | Depression a Subscale of the Brief Symptom Inventory (BSI) | Baseline | 0.75 units on a scale | Standard Deviation 0.76 |
| Wait-list Control | Depression a Subscale of the Brief Symptom Inventory (BSI) | 6 month | 0.46 units on a scale | Standard Deviation 0.62 |
p-value: 0.045Mixed Models Analysis
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.
Time frame: Baseline and 6 month assessment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nuevo Amanecer Peer Support Program | Somatization a Subscale of the Brief Symptom Inventory (BSI) | Baseline | 0.93 units on a scale | Standard Deviation 0.78 |
| Nuevo Amanecer Peer Support Program | Somatization a Subscale of the Brief Symptom Inventory (BSI) | 6 month | 0.52 units on a scale | Standard Deviation 0.51 |
| Wait-list Control | Somatization a Subscale of the Brief Symptom Inventory (BSI) | Baseline | 0.75 units on a scale | Standard Deviation 0.59 |
| Wait-list Control | Somatization a Subscale of the Brief Symptom Inventory (BSI) | 6 month | 0.66 units on a scale | Standard Deviation 0.6 |
p-value: 0.005Mixed Models Analysis