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.

Final Research Report

View this project's final research report.

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.

Conflict of Interest Disclosures

Project Information

Kristi Graves, PhD
Georgetown University
$2,019,316
10.25302/05.2020.AD.12115365
Nueva Vida Intervention: Improving QOL in Latina Breast Cancer Survivors and Their Caregivers

Key Dates

May 2013
September 2018
2013
2018

Study Registration Information

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Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
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Last updated: November 30, 2022