Breast Cancer Clinical Trial
Official title:
Nueva Vida Intervention: Improving QOL in Latina Breast Cancer Survivors and Their Caregivers
Latina breast cancer survivors report lower quality of life (QOL) than non-Latina survivors. Lower QOL can lead to poorer functional and cancer-related survival outcomes. The friends and family of Latina cancer patients are also impacted by a loved one's diagnosis of breast cancer. Through strong community-academic partnerships, the investigators seek to improve the QOL of Latina survivors and their caregivers with a culturally-relevant intervention. In this project, the investigators plan to further develop and refine the intervention and then test it through a randomized controlled trial. First, the investigators will conduct in-depth qualitative interviews with 10 survivor-caregiver dyads (pairs) to see if the intervention fits for survivors and caregivers in different parts of the country. Then, the investigators will revise the intervention. Finally, the investigators will test the intervention in a randomized controlled trial. The investigators will invite 125 survivor-caregiver dyads to be a part of our study. Half will be asked to complete the intervention and half will be offered the usual services, such as support groups. The information learned from this study could help improve the quality of life in Latina breast cancer survivors and their caregivers. Physicians, survivors, and community groups can also benefit from this study because they will have more information about the needs of Latina breast cancer survivors. The investigators hope to use the information to help other types of survivors and caregivers in the future.
What is the Nueva Vida Intervention? The "Nueva Vida Intervention: Improving Quality of Life
in Latina Breast Cancer Survivors and Their Caregivers" is a randomized controlled trial
(RCT) that was co-developed by a Latina breast cancer survivor who is trained as a mental
health professional. The program was developed for Nueva Vida, a community-based organization
(CBO) in the Washington, DC metropolitan area that serves Latina breast cancer survivors and
their families. We are comparing the intervention to the usual services provided at our four
partner community-based organizations.
How is the Nueva Vida Intervention Structured? The 8-session psycho-educational quality of
life intervention includes group-based skill-building workshops in which Latina survivors and
their caregivers are part of concurrently-held but separate groups (survivors in one room;
caregivers in another). This separation meets the needs of Latino participants by encouraging
them to freely share their experiences and feelings without worrying about upsetting the
other person. Five of the eight sessions address core topics: Introduction and The Impact of
Cancer on the Family, Stress Management, Improving Communication: Family, Friends, and
Providers, Spirituality and Cancer, and Balancing Physical and Emotional Needs.
The remaining three sessions are selected by the intervention participants based on their own
needs and interests from the following options: Anger Management, Intimacy after Cancer:
Emotional and Sexual, Trauma and Cancer, Role Changes, Understanding Distress and Depression,
Myths and Cancer, Including Others in Helping Caregivers, and Putting Our Lives in Order. At
the end of the intervention everyone participates in a graduation ceremony.
How does the Nueva Vida Intervention Reflect Latino Values? The Nueva Vida intervention
reflects Latino values, including personalismo (warm, personal relationships), familismo
(emphasizing the family unit in managing a cancer diagnosis) and framing the sessions as
workshops to avoid stigma associated with mental health care.
Where will the Nueva Vida Intervention Study take place? We will evaluate the Nueva Vida
Intervention within a multi-site RCT at four community-based organizations in Washington, DC
(Nueva Vida), New York, New York (SHARE, Gilda's Club New York City), and San Jose,
California (Latinas Contra Cancer).
What is Involved in Study Participation? Latina survivors and their caregivers will be
assigned by chance (randomized) to either the Nueva Vida Intervention or to usual care.
Survivors and caregivers assigned to usual care can take part in any and all of the services
provided at one of the four community-based organizations who are study partners. Both
survivors and caregivers will complete informed consent forms and telephone surveys at the
beginning of the study, about 4 months later, and again 6 months later. Survivors and
caregivers receive gift cards in appreciation of their time for completing the surveys.
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