Breast NeoplasmsNCT02931552
Nuevo Amanecer II: Translating a Stress Management Program for Latinas
A study testing Nuevo Amancer-II Stress Management Program in people with Breast Neoplasms and Psychology, Social, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms, Psychology, Social
- What is being tested?
- Nuevo Amancer-II Stress Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Terminal illness
- Stage IV breast cancer (distant metastasis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translating a Stress Management Program for Latinas
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.
Read the detailed description
The purpose of this study is to adapt Nuevo Amanecer (NA-I) for use in rural populations and test the effects of the new adapted program, NA-II, in a 6-month RCT among 150 rural, low literacy Latinas with non-metastatic breast cancer. Primary outcomes will consist of quality of life and distress. In an ancillary study, the investigators will compare the intervention and wait-list control groups on biomarkers of stress (hair and saliva cortisol) and aging (telomere length from saliva). Finally, to facilitate statewide dissemination of Nuevo Amanecer-II (NA-II), the investigators will develop a guide to implementation for community-based organizations.
The investigators will adapt NA-I to be appropriate for rural and low-literacy Latinas with breast cancer. Needed program adaptations will be identified through a formative evaluation consisting of semi-structured interviews with key informants (e.g., rural Latina breast cancer survivors, advocates, health care providers) and iterative consultations with community representatives in three rural areas with large Latino populations. Results will be applied by the study team and community advisors to adapt NA-I to create NA-II and create the implementation guide.
The investigators will identify key individual, organizational, and community factors that facilitate implementation and support scalability and statewide dissemination through a process evaluation where the investigators will track key implementation activities and debrief program participants, interventionists, and advocates. Products will include NA-II interventionist and participant manuals and a guide to implementation for organizations seeking to replicate the program.
- Conditions
- Breast Neoplasms, Psychology, Social
- Being tested
- Nuevo Amancer-II Stress Management Program
- Keywords
- Breast cancer, Latinas, Peer support counselor, Spanish speaking, Community based, Rural
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuevo Amancer-II Stress Management ProgramBehavioural
Also called Nuevo Amanecer II (A New Dawn) cognitive-behavioral 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline and 6 month assessment
Change in Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
Measured: Baseline and 6 month assessment
Secondary outcomes (8)
Change Anxiety Score, a Subscale of the Brief Symptom Inventory (BSI)
Measured: Baseline and 6 month assessment
Change Somatization Score, a Subscale of the Brief Symptom Inventory (BSI)
Measured: Baseline and 6 month assessment
Change in Personal Health Questionnaire Depression Scale (PHQ-8) Score
Measured: Baseline and 6 month assessment
Change Perceived Stress Scale (PSS-10) Score
Measured: Baseline and 6 month assessment
Change MOS Health Distress Scale Score
Measured: Baseline and 6 month assessment
Change in long-term stress level measured by cortisol levels collected from hair sample.
Study staff will collect hair sample pre-intervention (baseline) and at the 6-month follow-up. All hair samples will then be picked up by San Francisco State University Health Equity Research Laboratory (HER) staff for cortisol characterization.
Measured: Baseline and 6 month assessment
Change in telomere length, a measure of biological aging, in DNA collected from saliva sample.
Study staff will collect a saliva sample pre-intervention (baseline) and at the 6-month follow-up. All saliva samples will then be picked up by San Francisco State University Health Equity Research Laboratory (HER) staff to process to extract DNA and measure telomeres.
Measured: Baseline and 6 month assessment
Change in diurnal cortisol rhythm to assess regulatory patterns through saliva samples collected over 3 days, 3 times/day.
Participants will collect nine saliva samples pre-invention (baseline) and at the 6-month follow-up. The first two samples will be taken within the first half hour of waking (first upon awakening and 30 minutes after waking). Participants will collect the last sample right before they go to bed. All saliva samples will then be picked up by San Francisco State University Health Equity Research Laboratory (HER) staff for cortisol characterization.
Measured: Baseline and 6 month assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- California Breast Cancer Research Program, National Institute on Aging (NIA), Circulo de Vida Cancer Support and Resource Center, Cancer Resource Center of the Desert, Family Service Agency of the Central Coast, Kaweah Delta Health Care District, San Francisco State University
- Responsible party
- Sponsor
- Investigators
- Steven Gregorich, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931552
- Sponsor's protocol ID
- 16-18737
- Other IDs
- 21OB-0135, 4P30AG015272-20
- Status last verified
- Apr 2019
- First submitted
- 11 Oct 2016
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35967922Bonilla 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.
PubMed 34998436Bonilla 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.
PubMed 33563263Samayoa 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.
PubMed 32132128
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating a Stress Management Program for Latinas
- ClinicalTrials.gov ID
- NCT02931552
- Acronym / sponsor ID
- 16-18737
- Conditions
- Breast Neoplasms, Psychology, Social
- Keywords
- Breast cancer, Latinas, Peer support counselor, Spanish speaking, Community based, Rural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- California Breast Cancer Research Program, National Institute on Aging (NIA), Circulo de Vida Cancer Support and Resource Center, Cancer Resource Center of the Desert, Family Service Agency of the Central Coast, Kaweah Delta Health Care District, San Francisco State University
- Study start
- Sep 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to adapt Nuevo Amanecer (NA-I) for use in rural populations and test the effects of the new adapted program, NA-II, in a 6-month RCT among 150 rural, low literacy Latinas with non-metastatic breast cancer. Primary outcomes will consist of quality of life and distress. In an ancillary study, the investigators will compare the intervention and wait-list control groups on biomarkers of stress (hair and saliva cortisol) and aging (telomere length from saliva). Finally, to facilitate statewide dissemination of Nuevo Amanecer-II (NA-II), the investigators will develop a guide to implementation for community-based organizations.
The investigators will adapt NA-I to be appropriate for rural and low-literacy Latinas with breast cancer. Needed program adaptations will be identified through a formative evaluation consisting of semi-structured interviews with key informants (e.g., rural Latina breast cancer survivors, advocates, health care providers) and iterative consultations with community representatives in three rural areas with large Latino populations. Results will be applied by the study team and community advisors to adapt NA-I to create NA-II and create the implementation guide.
The investigators will identify key individual, organizational, and community factors that facilitate implementation and support scalability and statewide dissemination through a process evaluation where the investigators will track key implementation activities and debrief program participants, interventionists, and advocates. Products will include NA-II interventionist and participant manuals and a guide to implementation for organizations seeking to replicate the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nuevo Amancer-II Stress Management Program | Experimental | Behavioral: Nuevo Amancer-II Stress Management ProgramNuevo 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Terminal illness
- Stage IV breast cancer (distant metastasis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nuevo Amancer-II Stress Management ProgramAlso: Nuevo Amanecer II (A New Dawn) cognitive-behavioral stress management programParticipant 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. | Behavioural | Nuevo Amancer-II Stress Management Program |
Primary outcome
Change in Physical Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and 6 month assessment
Change in Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)
Time frame: Baseline and 6 month assessment
8 secondary outcomes
Change Anxiety Score, a Subscale of the Brief Symptom Inventory (BSI)
Time frame: Baseline and 6 month assessment
Change Somatization Score, a Subscale of the Brief Symptom Inventory (BSI)
Time frame: Baseline and 6 month assessment
Change in Personal Health Questionnaire Depression Scale (PHQ-8) Score
Time frame: Baseline and 6 month assessment
Change Perceived Stress Scale (PSS-10) Score
Time frame: Baseline and 6 month assessment
Change MOS Health Distress Scale Score
Time frame: Baseline and 6 month assessment
Change in long-term stress level measured by cortisol levels collected from hair sample.
Time frame: Baseline and 6 month assessment
Change in telomere length, a measure of biological aging, in DNA collected from saliva sample.
Time frame: Baseline and 6 month assessment
Change in diurnal cortisol rhythm to assess regulatory patterns through saliva samples collected over 3 days, 3 times/day.
Time frame: Baseline and 6 month assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Derived from this study: PubMed 35967922Samayoa 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.
- Derived from this study: PubMed 34998436Bonilla 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.
- Derived from this study: PubMed 33563263Bonilla 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.
- Derived from this study: PubMed 32132128Samayoa 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.
- Individual participant dataSharing planned: No
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Gregorich, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nuevo Amancer-II Stress Management Program in people with Breast Neoplasms and Psychology, Social, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Well-being Score, a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (time frame: Baseline and 6 month assessment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02931552, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.