N/A
N=272
Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers
Quality of Life · Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02222337 ↗Enrolled (actual)
272
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: PROMIS Physical Functioning — 44.61; 53.82; 45.07; 52.99 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nueva Vida Intervention (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Georgetown University
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PROMIS Physical Functioning |
44.61; 53.82; 45.07; 52.99 | — |
| PRIMARY PROMIS Satisfaction With Social Roles |
52.84; 58.64; 54.07; 59.45 | — |
| PRIMARY PROMIS Anxiety |
53.93; 48.41; 50.90; 48.70 | — |
| PRIMARY PROMIS Depression |
47.43; 43.95; 47.35; 44.49 | — |
| PRIMARY PROMIS Fatigue |
49.07; 53.06; 47.83; 46.68 | — |
| SECONDARY Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale) |
3.52; 3.23 | — |
| SECONDARY Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI) |
106.96; 107.96 | — |
| SECONDARY Satisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL) |
35.04; 34.63 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Survivors: Latina, has been diagnosed with breast cancer, speaks English or Spanish, has a Caregiver who is willing to participate.
- Caregivers: a primary caregiver for a Latina breast cancer survivor, speak English or Spanish
Exclusion Criteria
- Inability to understand spoken English and/or Spanish and/or
- Cognitive impairment that precludes informed consent (determined by the PIs or Co-Investigators who are mental health professionals).
Data sourced from ClinicalTrials.gov (NCT02222337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.