Clinical trial NCT02222337: Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers
Official title: Nueva Vida Intervention: Improving QOL in Latina Breast Cancer Survivors and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Breast Cancer
Keywords: behavioral intervention
quality of life
breast cancer
Latina
caregiver
PCORI
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Nueva Vida, Inc.
name: Latinas Contra Cancer
name: Gilda's Club NYC
name: SHARE
First posted: 2014-08-21
Enrollment: 272
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

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:

1. Inability to understand spoken English and/or Spanish and/or
2. Cognitive impairment that precludes informed consent (determined by the PIs or Co-Investigators who are mental health professionals).

Primary outcomes:
measure: PROMIS Physical Functioning
timeFrame: 6 months
measure: PROMIS Satisfaction With Social Roles
timeFrame: 6 months
measure: PROMIS Anxiety
timeFrame: 6 months
measure: PROMIS Depression
timeFrame: 6 months
measure: PROMIS Fatigue
timeFrame: 6 months
Secondary outcomes:
measure: Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale)
timeFrame: 6-months
measure: Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI)
timeFrame: 6 Months
measure: Satisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL)
timeFrame: 6-months
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Latinas Contra Cancer
state: California
city: Washington
country: United States
facility: Nueva Vida
state: District of Columbia
city: New York
country: United States
facility: Gilda's Club New York City
state: New York
city: New York
country: United States
facility: SHARE
state: New York
Study officials:
affiliation: Georgetown University
name: Kristi D Graves, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rush CL, Darling M, Elliott MG, Febus-Sampayo I, Kuo C, Munoz J, Duron Y, Torres M, Galvan CC, Gonzalez F, Caicedo L, Napoles A, Jensen RE, Anderson E, Graves KD. Engaging Latina cancer survivors, their caregivers, and community partners in a randomized controlled trial: Nueva Vida intervention. Qual Life Res. 2015 May;24(5):1107-18. doi: 10.1007/s11136-014-0847-9. Epub 2014 Nov 8.