NCT02931552

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

2.1 years

First QC Date

October 11, 2016

Last Update Submit

April 3, 2019

Conditions

Breast NeoplasmsPsychology, Social

Keywords

Breast cancerLatinasPeer support counselorSpanish speakingCommunity basedRural

Outcome Measures

Primary Outcomes (6)

  • Change in Physical Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

    Baseline and 6 month assessment

  • Change in Social/Family Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

    Baseline and 6 month assessment

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

    Baseline and 6 month assessment

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

    Baseline and 6 month assessment

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

    Baseline and 6 month assessment

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

    Baseline and 6 month assessment

Secondary Outcomes (8)

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

    Baseline and 6 month assessment

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

    Baseline and 6 month assessment

  • Change in Personal Health Questionnaire Depression Scale (PHQ-8) Score

    Baseline and 6 month assessment

  • Change Perceived Stress Scale (PSS-10) Score

    Baseline and 6 month assessment

  • Change MOS Health Distress Scale Score

    Baseline and 6 month assessment

  • +3 more secondary outcomes

Study Arms (2)

Nuevo Amancer-II Stress Management Program

EXPERIMENTAL

Nuevo Amanecer-II (NA-II) is a 10-week peer-delivered cognitive-behavioral stress management program. Participants receive the stress management program as soon as possible after randomization.

Behavioral: Nuevo Amancer-II Stress Management Program

Wait-list Control Group

NO INTERVENTION

Waits six months and at the end of the six months is offered the option of receiving the NA-II program.

Interventions

Nuevo Amancer-II Stress Management ProgramBEHAVIORAL

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.

Also known as: Nuevo Amanecer II (A New Dawn) cognitive-behavioral stress management program
Nuevo Amancer-II Stress Management Program

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identifies as Latina
  • Diagnosed with Stage 0, I, II, or III (non-metastatic) breast cancer
  • Primarily Spanish-speaking, or Spanish monolingual
  • Aged 18 or older
  • Living in surrounding areas of Tulare (Visalia, Dinuba), Santa Cruz (Eastside Santa Cruz, Watsonville, Freedom), or Imperial Valley (El Centro) counties, California.

You may not qualify if:

  • Terminal illness
  • Stage IV breast cancer (distant metastasis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, California, United States

Location

Related Publications (4)

  • Samayoa C, Santana-Ufret V, Santoyo-Olsson J, Strassle PD, Stewart A, Bonilla J, Escalera C, Mendez RM, Marquez-Magana L, Ortiz C, Ceballos RM, Napoles AM. Cortisol levels in rural Latina breast cancer survivors participating in a peer-delivered cognitive-behavioral stress management intervention: The Nuevo Amanecer-II RCT. Compr Psychoneuroendocrinol. 2022 Jun 24;11:100153. doi: 10.1016/j.cpnec.2022.100153. eCollection 2022 Aug.

    PMID: 35967922DERIVED

  • 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: 34998436DERIVED

  • 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: 33563263DERIVED

  • Samayoa C, Santoyo-Olsson J, Escalera C, Stewart AL, Ortiz C, Marquez-Magana L, Urias A, Gonzalez N, Cervantes SA, Torres-Nguyen A, Parada-Ampudia L, Napoles AM. Participant-Centered Strategies for Overcoming Barriers to Biospecimen Collection among Spanish-Speaking Latina Breast Cancer Survivors. Cancer Epidemiol Biomarkers Prev. 2020 Mar;29(3):606-615. doi: 10.1158/1055-9965.EPI-19-0942.

    PMID: 32132128DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Steven Gregorich, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

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

October 11, 2016

First Posted

October 13, 2016

Study Start

September 1, 2016

Primary Completion

October 1, 2018

Study Completion

February 1, 2019

Last Updated

April 5, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)