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.
COMPLETED
NA
151 participants
Baseline and 6 month assessment
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
| 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
| 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
| 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=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
66 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
50.8 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
50.2 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
50.5 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
76 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
75 participants
n=7 Participants
|
151 participants
n=5 Participants
|
|
Educational attainment
Less than 6th grade
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Educational attainment
6th grade to less than high school
|
15 participants
n=5 Participants
|
12 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Educational attainment
High school graduate
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Health insurance
Any private
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Health insurance
Public insurance only
|
62 participants
n=5 Participants
|
56 participants
n=7 Participants
|
118 participants
n=5 Participants
|
|
Health insurance
None
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Health insurance
Missing data
|
0 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Breast cancer
Ductal Carcinoma In Situ (DCIS)
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Breast cancer
Invasive
|
56 participants
n=5 Participants
|
55 participants
n=7 Participants
|
111 participants
n=5 Participants
|
|
Stage
0 (in situ)
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Stage
I (1)
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Stage
II (2)
|
31 participants
n=5 Participants
|
26 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Stage
III (3)
|
13 participants
n=5 Participants
|
18 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Surgery
Breast conserving
|
43 participants
n=5 Participants
|
41 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Surgery
Mastectomy
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Adjuvant treatment
Both chemotherapy and radiation
|
33 participants
n=5 Participants
|
27 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Adjuvant treatment
Only radiation
|
18 participants
n=5 Participants
|
24 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Adjuvant treatment
Only chemotherapy
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Adjuvant treatment
No treatment
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 month assessmentPopulation: 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
| 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 assessmentPopulation: 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
| 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 assessmentPopulation: 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
| 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 assessmentPopulation: 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
| 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)
Baseline
|
16.52 units on a scale
Standard Deviation 5.43
|
17.33 units on a scale
Standard Deviation 5.08
|
|
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
|
PRIMARY outcome
Timeframe: Baseline and 6 month assessmentPopulation: 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
| 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)
Baseline
|
8.92 units on a scale
Standard Deviation 3.80
|
9.22 units on a scale
Standard Deviation 3.43
|
|
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
|
PRIMARY outcome
Timeframe: Baseline and 6 month assessmentPopulation: 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
| 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 assessmentPopulation: 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
| 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 assessmentPopulation: 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
| 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 assessmentPopulation: 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
| 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 assessmentPopulation: 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
| 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
Wait-list Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place