Nuevo Amanecer II: Translating a Stress Management Program for Latinas

NCT02931552 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2019-04-05

No results posted yet for this study

Summary

The primary aim is to assess the effectiveness of the Nuevo Amanecer-II (NA-II) cognitive-behavioral stress management program through a 6-month RCT with 150 Spanish-speaking Latinas with breast cancer in three rural settings in terms of improving quality of life (QoL) and reducing distress, compared to a usual care control group (that is offered the program at the end of the 6 months). The investigators will also test the effects of the program on biomarkers of stress (hair and saliva cortisol) and aging (telomere length from saliva). Trained Latinas, called Compañeras (Companions), who have had breast cancer deliver the stress management program in-person to Spanish-speaking Latinas with breast cancer.

Conditions

  • Breast Neoplasms
  • Psychology, Social

Interventions

BEHAVIORAL

Nuevo Amancer-II Stress Management Program

Participant meets weekly with a trained interventionist called a Compañera (a peer who has had breast cancer) to complete a structured 10-week program designed to develop cognitive and behavioral skills to manage stress and distress, improve communication with family and clinicians, and increase knowledge of self-management after breast cancer.

Sponsors & Collaborators

  • California Breast Cancer Research Program

    collaborator OTHER
  • National Institute on Aging (NIA)

    collaborator NIH
  • Circulo de Vida Cancer Support and Resource Center

    collaborator OTHER
  • Cancer Resource Center of the Desert

    collaborator UNKNOWN
  • Family Service Agency of the Central Coast

    collaborator UNKNOWN
  • Kaweah Delta Health Care District

    collaborator OTHER
  • San Francisco State University

    collaborator OTHER
  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Steven Gregorich, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-10-31
Completion
2019-02-28

Countries

  • United States

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02931552 on ClinicalTrials.gov