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Trial Outcomes & Findings for Nuevo Amanecer: Promoting the Psychosocial Health of Latinas (NCT NCT01383174)

NCT ID: NCT01383174

Last Updated: 2019-01-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

151 participants

Primary outcome timeframe

Baseline and 6 month assessment

Results posted on

2019-01-15

Participant Flow

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.

Participant milestones

Participant milestones
Measure
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.
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.
Baseline Assessment
STARTED
76
75
Baseline Assessment
COMPLETED
76
75
Baseline Assessment
NOT COMPLETED
0
0
3 Month Assessment
STARTED
76
75
3 Month Assessment
COMPLETED
70
74
3 Month Assessment
NOT COMPLETED
6
1
6 Month Assessment
STARTED
76
74
6 Month Assessment
COMPLETED
71
73
6 Month Assessment
NOT COMPLETED
5
1

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
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

Nuevo Amanecer: Promoting the Psychosocial Health of Latinas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Nuevo Amanecer Peer Support Program
n=76 Participants
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.
Wait-list Control
n=75 Participants
Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
Total
n=151 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
66 Participants
n=99 Participants
70 Participants
n=107 Participants
136 Participants
n=206 Participants
Age, Categorical
>=65 years
10 Participants
n=99 Participants
5 Participants
n=107 Participants
15 Participants
n=206 Participants
Age, Continuous
50.8 years
STANDARD_DEVIATION 11.9 • n=99 Participants
50.2 years
STANDARD_DEVIATION 9.9 • n=107 Participants
50.5 years
STANDARD_DEVIATION 10.9 • n=206 Participants
Sex: Female, Male
Female
76 Participants
n=99 Participants
75 Participants
n=107 Participants
151 Participants
n=206 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
76 Participants
n=99 Participants
75 Participants
n=107 Participants
151 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
White
76 Participants
n=99 Participants
75 Participants
n=107 Participants
151 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Region of Enrollment
United States
76 participants
n=99 Participants
75 participants
n=107 Participants
151 participants
n=206 Participants
Educational attainment
Less than 6th grade
50 participants
n=99 Participants
50 participants
n=107 Participants
100 participants
n=206 Participants
Educational attainment
6th grade to less than high school
15 participants
n=99 Participants
12 participants
n=107 Participants
27 participants
n=206 Participants
Educational attainment
High school graduate
11 participants
n=99 Participants
13 participants
n=107 Participants
24 participants
n=206 Participants
Health insurance
Any private
11 participants
n=99 Participants
10 participants
n=107 Participants
21 participants
n=206 Participants
Health insurance
Public insurance only
62 participants
n=99 Participants
56 participants
n=107 Participants
118 participants
n=206 Participants
Health insurance
None
3 participants
n=99 Participants
2 participants
n=107 Participants
5 participants
n=206 Participants
Health insurance
Missing data
0 participants
n=99 Participants
7 participants
n=107 Participants
7 participants
n=206 Participants
Breast cancer
Ductal Carcinoma In Situ (DCIS)
20 participants
n=99 Participants
20 participants
n=107 Participants
40 participants
n=206 Participants
Breast cancer
Invasive
56 participants
n=99 Participants
55 participants
n=107 Participants
111 participants
n=206 Participants
Stage
0 (in situ)
20 participants
n=99 Participants
20 participants
n=107 Participants
40 participants
n=206 Participants
Stage
I (1)
12 participants
n=99 Participants
11 participants
n=107 Participants
23 participants
n=206 Participants
Stage
II (2)
31 participants
n=99 Participants
26 participants
n=107 Participants
57 participants
n=206 Participants
Stage
III (3)
13 participants
n=99 Participants
18 participants
n=107 Participants
31 participants
n=206 Participants
Surgery
Breast conserving
43 participants
n=99 Participants
41 participants
n=107 Participants
84 participants
n=206 Participants
Surgery
Mastectomy
33 participants
n=99 Participants
34 participants
n=107 Participants
67 participants
n=206 Participants
Adjuvant treatment
Both chemotherapy and radiation
33 participants
n=99 Participants
27 participants
n=107 Participants
60 participants
n=206 Participants
Adjuvant treatment
Only radiation
18 participants
n=99 Participants
24 participants
n=107 Participants
42 participants
n=206 Participants
Adjuvant treatment
Only chemotherapy
14 participants
n=99 Participants
11 participants
n=107 Participants
25 participants
n=206 Participants
Adjuvant treatment
No treatment
11 participants
n=99 Participants
13 participants
n=107 Participants
24 participants
n=206 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Nuevo Amanecer Peer Support Program
n=76 Participants
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.
Wait-list Control
n=75 Participants
Waits six months, and at the end of the six months is offered the option of participating in the 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
16.76 units on a scale
Standard Deviation 5.02
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
18.44 units on a scale
Standard Deviation 4.58

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Nuevo Amanecer Peer Support Program
n=76 Participants
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.
Wait-list Control
n=75 Participants
Waits six months, and at the end of the six months is offered the option of participating in the 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
12.66 units on a scale
Standard Deviation 4.25
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
14.47 units on a scale
Standard Deviation 3.81

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Nuevo Amanecer Peer Support Program
n=76 Participants
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.
Wait-list Control
n=75 Participants
Waits six months, and at the end of the six months is offered the option of participating in the 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
12.86 units on a scale
Standard Deviation 5.14
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 3.30
14.89 units on a scale
Standard Deviation 3.95

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Nuevo Amanecer Peer Support Program
n=76 Participants
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.
Wait-list Control
n=75 Participants
Waits six months, and at the end of the six months is offered the option of participating in the 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
19.92 units on a scale
Standard Deviation 5.22
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
17.33 units on a scale
Standard Deviation 5.08

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Nuevo Amanecer Peer Support Program
n=76 Participants
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.
Wait-list Control
n=75 Participants
Waits six months, and at the end of the six months is offered the option of participating in the 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
9.30 units on a scale
Standard Deviation 3.06
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 3.80
9.22 units on a scale
Standard Deviation 3.43

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Nuevo Amanecer Peer Support Program
n=76 Participants
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.
Wait-list Control
n=75 Participants
Waits six months, and at the end of the six months is offered the option of participating in the 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
68.83 units on a scale
Standard Deviation 15.33
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
77.02 units on a scale
Standard Deviation 15.62

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Nuevo Amanecer Peer Support Program
n=76 Participants
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.
Wait-list Control
n=75 Participants
Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
Anxiety a Subscale of the Brief Symptom Inventory (BSI)
Baseline
0.93 units on a scale
Standard Deviation 0.84
1.01 units on a scale
Standard Deviation 0.88
Anxiety a Subscale of the Brief Symptom Inventory (BSI)
6 month
0.39 units on a scale
Standard Deviation 0.53
0.58 units on a scale
Standard Deviation 0.76

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Nuevo Amanecer Peer Support Program
n=76 Participants
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.
Wait-list Control
n=75 Participants
Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
Depression a Subscale of the Brief Symptom Inventory (BSI)
Baseline
0.93 units on a scale
Standard Deviation 0.84
0.75 units on a scale
Standard Deviation 0.76
Depression a Subscale of the Brief Symptom Inventory (BSI)
6 month
0.38 units on a scale
Standard Deviation 0.48
0.46 units on a scale
Standard Deviation 0.62

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Nuevo Amanecer Peer Support Program
n=76 Participants
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.
Wait-list Control
n=75 Participants
Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
Somatization a Subscale of the Brief Symptom Inventory (BSI)
Baseline
0.93 units on a scale
Standard Deviation 0.78
0.75 units on a scale
Standard Deviation 0.59
Somatization a Subscale of the Brief Symptom Inventory (BSI)
6 month
0.52 units on a scale
Standard Deviation 0.51
0.66 units on a scale
Standard Deviation 0.60

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Nuevo Amanecer Peer Support Program
n=76 Participants
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.
Wait-list Control
n=75 Participants
Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
Breast Cancer-Specific Distress of the Intrusive Thoughts Scale
Baseline
7.96 units on a scale
Standard Deviation 8.46
8.65 units on a scale
Standard Deviation 8.91
Breast Cancer-Specific Distress of the Intrusive Thoughts Scale
6 month
3.87 units on a scale
Standard Deviation 5.79
6.27 units on a scale
Standard Deviation 8.42

Adverse Events

Nuevo Amanecer Peer Support Program

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Wait-list Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Anna Maria Napoles

University of California San Francisco

Phone: 415-476-6290

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place