Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers
NCT02222337 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 272
Last updated 2019-06-03
Summary
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.
Conditions
- Quality of Life
- Breast Cancer
Interventions
- BEHAVIORAL
-
Nueva Vida Intervention
The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The specific topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.
Sponsors & Collaborators
-
Nueva Vida, Inc.
collaborator INDUSTRY -
Latinas Contra Cancer
collaborator UNKNOWN -
Gilda's Club NYC
collaborator OTHER -
SHARE
collaborator UNKNOWN -
Georgetown University
lead OTHER
Principal Investigators
-
Kristi D Graves, Ph.D. · Georgetown University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-05-31
- Primary Completion
- 2017-01-24
- Completion
- 2017-12-31
Countries
- United States
Study Locations
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