N/A
Completed N=151
Nuevo Amanecer: Promoting the Psychosocial Health of Latinas
Breast Neoplasms · Psychology, Social
Source: ClinicalTrials.gov NCT01383174 ↗
Enrolled (actual)
151
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) — 15.29; 16.76; 19.44; 18.44 units on a scale — p=0.015
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) |
15.29; 16.76; 19.44; 18.44 | 0.015 sig |
| PRIMARY Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) |
13.67; 12.66; 13.72; 14.47 | .025 sig |
| PRIMARY Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) |
12.07; 12.86; 16.39; 14.89 | .004 sig |
| PRIMARY Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) |
16.52; 17.33; 21.31; 19.92 | .013 sig |
| PRIMARY Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) |
8.92; 9.22; 9.79; 9.30 | .267 |
| PRIMARY Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) |
66.46; 68.83; 80.64; 77.02 | .030 sig |
| SECONDARY Anxiety a Subscale of the Brief Symptom Inventory (BSI) |
0.93; 1.01; 0.39; 0.58 | .465 |
| SECONDARY Depression a Subscale of the Brief Symptom Inventory (BSI) |
0.93; 0.75; 0.38; 0.46 | .045 sig |
| SECONDARY Somatization a Subscale of the Brief Symptom Inventory (BSI) |
0.93; 0.75; 0.52; 0.66 | .005 sig |
| SECONDARY Breast Cancer-Specific Distress of the Intrusive Thoughts Scale |
7.96; 8.65; 3.87; 6.27 | .226 |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01383174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.