Nuevo Amanecer: Promoting the Psychosocial Health of Latinas

NCT01383174 | Completed Results DMC

• 2 other identifiers: 15BB-130015BB-1301
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Psychology, Social

Keywords

Breast cancer; Latinas; Peer support counselor; Spanish speaking; Community based

Outcome Measures

Primary Outcomes (6)

• Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

  FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: physical well-being subscale. Of 7 items, 1 was dropped because it was conceptually different from other items on that scale. Modified subscale was scored by summing items. Possible score ranges for physical well-being were 0-24. Higher scores indicated greater well-being.

  Baseline and 6 month assessment

• Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

  FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: social/family well-being subscale. Of 7 items, 2 were dropped because the items were conditional on having a partner (resulting in lots of missing data). Modified subscale was scored by summing items. Possible score ranges for social/family well-being were 0-20. Higher scores indicated greater well-being.

  Baseline and 6 month assessment

• Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

  FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: emotional well-being subscale. Of 6 items, 1 was dropped because of low item-scale correlations and it was conceptually different from the other items on that scale (only positively worded item on the scale). Modified subscale was scored by summing items. Possible score ranges for emotional well-being were 0-20. Higher scores indicated greater well-being.

  Baseline and 6 month assessment

• Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

  FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: breast cancer concerns subscale. Of 7 items, 2 were dropped because of low item-scale correlations and were conceptually different from the other items on that scale. Modified subscale was scored by summing items. Possible score ranges for emotional well-being were 0-28. Higher scores indicated greater well-being.

  Baseline and 6 month assessment

• Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

  FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: functional well-being subscale. Of 7 items, 3 were dropped because items were conceptually different and did not converge psychometrically with the other items on that scale; the remaining 4 items were specific to enjoyment of life, thus we renamed the subscale to "Enjoyment of Life". Modified subscale was scored by summing items. Possible score ranges for enjoyment of life were 0-16. Higher scores indicated greater well-being.

  Baseline and 6 month assessment

• Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

  FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to each of the FACT-B subscale. The total overall score is based on the sum of modified subscales (see above primary outcomes for modifications to subscales). Possible score ranges for the total overall score were 0-108. Higher scores indicated greater well-being.

  Baseline and 6 month assessment

Secondary Outcomes (4)

• Anxiety a Subscale of the Brief Symptom Inventory (BSI)

  Baseline and 6 month assessment

• Depression a Subscale of the Brief Symptom Inventory (BSI)

  Baseline and 6 month assessment

• Somatization a Subscale of the Brief Symptom Inventory (BSI)

  Baseline and 6 month assessment

• Breast Cancer-Specific Distress of the Intrusive Thoughts Scale

  Baseline and 6 month assessment

Study Arms (2)

Peer Support Program

EXPERIMENTAL

Nuevo Amanecer is the peer support program. Participants receive the peer support program as soon as possible after randomization.

Behavioral: Peer Support Program

Wait-list Control

NO INTERVENTION

Waits six months, and at the end of the six months is offered the option of participating in the peer support program.

Interventions

Peer Support Program BEHAVIORAL

* 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

Also known as: Nuevo Amanecer (A New Dawn)

Peer Support Program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous cancer diagnosis except for non-melanoma skin cancer
• Terminal illness
• Stage IV breast cancer (distant metastasis)

Sponsors & Collaborators

• University of California, San Francisco: lead
• California Breast Cancer Research Program: collaborator
• Circulo de Vida Cancer Support and Resource Center: collaborator

Study Sites (1)

Unknown Facility

Multiple Locations, California, United States

Location

Related Publications (6)

• Bonilla J, Alhomsi A, Santoyo-Olsson J, Stewart AL, Ortiz C, Samayoa C, Torres-Nguyen A, Palomino H, Coleman V, Urias A, Gonzalez N, Cervantes SA, Duron Y, Napoles AM. Sharing research results with Latina breast cancer survivors who participated in a community-engaged behavioral RCT study: a descriptive cross-sectional survey study. Trials. 2022 Jan 8;23(1):25. doi: 10.1186/s13063-021-05945-8.

  PMID: 34998436 DERIVED

• Chacon L, Santoyo-Olsson J, Samayoa C, Alhomsi A, Stewart AL, Ortiz C, Escalera C, Napoles AM. Self-Efficacy for Coping with Breast Cancer Treatment Among Spanish-Speaking Latinas. Health Equity. 2021 Apr 26;5(1):245-252. doi: 10.1089/heq.2020.0152. eCollection 2021.

  PMID: 33937611 DERIVED

• Bonilla J, Escalera C, Santoyo-Olsson J, Samayoa C, Ortiz C, Stewart AL, Napoles AM. The importance of patient engagement to quality of breast cancer care and health-related quality of life: a cross-sectional study among Latina breast cancer survivors in rural and urban communities. BMC Womens Health. 2021 Feb 9;21(1):59. doi: 10.1186/s12905-021-01200-z.

  PMID: 33563263 DERIVED

• Napoles AM, Santoyo-Olsson J, Stewart AL, Ortiz C, Garcia-Jimenez M. Evaluating the Implementation of a Translational Peer-Delivered Stress Management Program for Spanish-Speaking Latina Breast Cancer Survivors. J Cancer Educ. 2018 Aug;33(4):875-884. doi: 10.1007/s13187-017-1202-y.

  PMID: 28275966 DERIVED

• Napoles AM, Ortiz C, Santoyo-Olsson J, Stewart AL, Gregorich S, Lee HE, Duron Y, McGuire P, Luce J. Nuevo Amanecer: results of a randomized controlled trial of a community-based, peer-delivered stress management intervention to improve quality of life in Latinas with breast cancer. Am J Public Health. 2015 Jul;105 Suppl 3(Suppl 3):e55-63. doi: 10.2105/AJPH.2015.302598. Epub 2015 Apr 23.

  PMID: 25905829 DERIVED

• Napoles AM, Santoyo-Olsson J, Ortiz C, Gregorich S, Lee HE, Duron Y, Graves K, Luce JA, McGuire P, Diaz-Mendez M, Stewart AL. Randomized controlled trial of Nuevo Amanecer: a peer-delivered stress management intervention for Spanish-speaking Latinas with breast cancer. Clin Trials. 2014 Apr;11(2):230-8. doi: 10.1177/1740774514521906. Epub 2014 Feb 26.

  PMID: 24577971 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Anna Maria Napoles
• Organization: University of California San Francisco

anapoles@ucsf.edu

415-476-6290

Study Officials

• Steven Gregorich, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: June 28, 2011
• Study Start: February 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: January 15, 2019
• Results First Posted: June 15, 2015

Record last verified: 2019-01

Locations

US (1)