Results Summary
What was the research about?
Women with breast cancer face challenges that may affect their quality of life. They may feel tired, anxious, or sad. Also, family members and friends may feel stress from caring for the women and themselves. These challenges may continue after women have completed treatment. Latina women who have had breast cancer may have lower quality of life than non-Latina women with breast cancer.
In this study, the research team compared the breast cancer support Latina women and their caregivers usually get from community centers with a new program called Nueva Vida. The team looked at women and caregivers’ quality of life and how satisfied women were with their cancer care.
What were the results?
Women in the Nueva Vida program and those who got usual support didn’t differ in
- How tired, anxious, or sad they felt
- How well they could move around to perform daily tasks
- Their feelings about their social life
- Whether they felt satisfied with their cancer care
Caregivers in the Nueva Vida program and those who got usual support didn’t differ in their quality of life.
Who was in the study?
The study included 136 Latina women and 136 caregivers who spoke English or Spanish. Women were undergoing or had completed treatment for breast cancer. Women received care at four community centers that serve Latino families. The centers were in New York City; San Jose, California; and Washington, DC.
What did the research team do?
Each woman asked an adult caregiver to be in the study with them. The research team assigned each pair by chance to be in Nueva Vida or to get usual support. In Nueva Vida, a trained group leader held eight workshops weekly or biweekly over two to four months at the community centers. Five of the workshops covered
- How cancer affects families
- Coping with stress
- Talking with your caregiver
- Faith and cancer
- Balancing physical and emotional needs
Women and caregivers voted on three other topics, such as role changes and cancer myths. People chose whether they wanted to have the workshops in English or Spanish.
Those who received usual support at their center could take part in social events, support groups, and workshops on living with cancer. They could also get help making healthcare choices.
The research team gave women and caregivers surveys at the start of the study, after the final workshop, and six months later.
Latina women who had been treated for breast cancer, their caregivers, and doctors gave input during the study.
What were the limits of the study?
The study took place at community centers that serve Latino families in three cities. Results may differ in other places or at other types of centers. If women and caregivers who went to the workshops talked about them with those who didn’t, it could have affected the study results.
Future research could look at other ways to support Latina women with breast cancer and their caregivers.
How can people use the results?
Cancer centers can consider these results when looking for ways to support Latina women with breast cancer and their caregivers.
Professional Abstract
Objective
To evaluate the effectiveness of the Nueva Vida intervention on quality of life among Latina breast cancer survivors and their caregivers compared with usual support
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 136 survivor-caregiver dyads, with survivor defined as any woman who has ever received a breast cancer diagnosis |
| Interventions/ Comparators |
|
| Outcomes |
Primary: survivors’ and caregivers’ quality of life as measured by PROMIS® domains of anxiety, depression, fatigue, physical functioning, and social functioning Secondary: survivors’ satisfaction with cancer care |
| Timeframe | 6-month follow-up for primary outcome |
This randomized controlled trial compared the Nueva Vida intervention, a series of workshops designed to teach communication and stress management skills, with current cancer support at Latino-oriented community-based organizations. Participants were Latina breast cancer survivors and their caregivers.
Researchers recruited Latina women who had ever received a breast cancer diagnosis, considered survivors, from a total of four community-based cancer support organizations in New York City; San Jose, California; and Washington, DC. After enrolling in the study, survivors identified an adult caregiver to participate in the study with them. Then researchers randomized the survivor-caregiver dyads to receive either Nueva Vida or usual support, and community partners implemented the intervention.
Nueva Vida included eight two-hour workshops held weekly or biweekly over two to four months. Trained moderators led workshops in Spanish or English. Five of the eight workshops covered designated topics: effect of cancer on the family, stress management, improving communication, spirituality and cancer, and balancing physical and emotional needs. The remaining three workshops were on topics that survivors and caregivers selected.
Survivor-caregiver dyads receiving usual support could participate in services available at their community-based organizations. Services included support groups, social activities, patient navigation, and educational workshops.
The study included 136 survivor-caregiver dyads, or 272 total participants, who spoke English or Spanish.
Researchers surveyed participants by telephone at baseline, immediately after their final workshop, and again six months later. The surveys measured survivors’ and caregivers’ quality of life using the Patient-Reported Outcomes Measurement Information System (PROMIS®) domains and survivors’ satisfaction with cancer care.
Latina breast cancer survivors, caregivers, clinicians, and patient advocates helped the researchers throughout the study, including providing feedback on how to deliver the Nueva Vida intervention in ways that consider participants’ cultural differences.
Results
Survivors who attended the Nueva Vida intervention workshops and those receiving usual support did not differ significantly in anxiety, fatigue, depression, physical functioning, social functioning, or satisfaction with cancer care.
Caregivers who attended the Nueva Vida workshops and those receiving usual support did not differ significantly in any quality of life domains.
Limitations
The study took place at community-based organizations that serve Latino families in three metropolitan areas. Results may differ in other settings or types of organizations. The Nueva Vida intervention workshops and usual support took place at the same locations. It is possible that Nueva Vida participants discussed the workshops with those receiving usual support. If this happened, it could have affected results.
Conclusions and Relevance
A program designed to teach communication and stress management skills did not result in statistically significant changes in quality of life or satisfaction with cancer care for breast cancer survivors or caregivers, compared with usual support.
Future Research Needs
Future research could explore other ways of improving quality of life among Latina cancer survivors and their caregivers.
Final Research Report
View this project's final research report.
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Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:
- Reviewers inquired about the lack of attention to missing data in the report and the use of complete case analysis to compare the two study arms, as this type of analysis tends to introduce potential bias into the results. The researchers responded by analyzing their data using mixed effects models, which accounted for missing data. These models also allowed them to include almost their entire sample rather than only complete cases, giving them a more robust result. In their limitations section, the researchers also discussed the issue of the amount of missing data.
- Reviewers suggested that the effects of the intervention might have been greater if the usual care control group did not already have relatively high engagement and receive some culturally sensitive services. The reviewers suggested using a term other than, usual care, for the control arm. The researchers agreed that the quality of service their community partners provided was high and has made finding an intervention effect more challenging. They retained the term, usual care, because they had used it in previous publications, and the term is widely used. However, they also added context in the report about what usual care represented in this study.
- Reviewers noted that because the decision to control for baseline scores is a complex one in randomized controlled trials, the researchers should provide additional discussion about their choices. The researchers argued that for randomized controlled trials statisticians widely agree on controlling for baseline scores as a way to increase precision and statistical power. They added information to their analysis description about their choices for the covariates to add to their analytic model.