Clinical trial · Interventional
Nuevo Amanecer II: Translating a Stress Management Program for Latinas
Translating a Stress Management Program for Latinas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Psychology, Social | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nuevo Amancer-II Stress Management Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nuevo Amancer-II Stress Management Program
- description
- 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.
- interventionNames
- Behavioral: Nuevo Amancer-II Stress Management Program
- type
- NO_INTERVENTION
- label
- Wait-list Control Group
- description
- Waits six months and at the end of the six months is offered the option of receiving the NA-II program.
Primary outcomes (6)
- measure
- Change in Physical Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
- timeFrame
- Baseline and 6 month assessment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Terminal illness * Stage IV breast cancer (distant metastasis)
References
Publications (4)
- DERIVEDSamayoa 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 35967922
- DERIVEDBonilla 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
- DERIVEDBonilla 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
- DERIVEDSamayoa 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 32132128