Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers
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|ClinicalTrials.gov Identifier: NCT02222337|
Recruitment Status : Active, not recruiting
First Posted : August 21, 2014
Last Update Posted : June 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Quality of Life Breast Cancer||Behavioral: Nueva Vida Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||272 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Nueva Vida Intervention: Improving QOL in Latina Breast Cancer Survivors and Their Caregivers|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||January 24, 2017|
|Estimated Study Completion Date :||December 2017|
Active Comparator: Nueva Vida Intervention
Nueva Vida Intervention consists of 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.
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.
No Intervention: Usual Care
Usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.
- Patient Reported Outcomes Measurement Information System (PROMIS) physical functioning [ Time Frame: 6 months ]Measure Quality of Life physical functioning
- PROMIS satisfaction with social roles [ Time Frame: 6 months ]Quality of Life: social roles
- PROMIS anxiety [ Time Frame: 6 months ]Quality of life: Anxiety
- PROMIS depression [ Time Frame: 6 months ]Quality of life: depression
- Communication [ Time Frame: 6-months ]Communication with providers; communication between survivor and caregiver
- Satisfaction with Care [ Time Frame: 6-months ]Satisfaction with health care received by the breast cancer survivor from her oncology health care providers or general health care providers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222337
|United States, California|
|Latinas Contra Cancer|
|San Jose, California, United States, 95110|
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20007|
|United States, New York|
|Gilda's Club New York City|
|New York, New York, United States, 10014|
|New York, New York, United States, 95110|
|Principal Investigator:||Kristi D Graves, Ph.D.||Georgetown University|