Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02222337
Recruitment Status : Active, not recruiting
First Posted : August 21, 2014
Last Update Posted : June 5, 2017
Nueva Vida, Inc.
Latinas Contra Cancer
Gilda's Club New York City
Information provided by (Responsible Party):
Kristi Graves, PhD, Georgetown University

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.

Condition or disease Intervention/treatment Phase
Quality of Life Breast Cancer Behavioral: Nueva Vida Intervention Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 272 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Patient Reported Outcomes Measurement Information System (PROMIS) physical functioning [ Time Frame: 6 months ]
    Measure Quality of Life physical functioning

  2. PROMIS satisfaction with social roles [ Time Frame: 6 months ]
    Quality of Life: social roles

  3. PROMIS anxiety [ Time Frame: 6 months ]
    Quality of life: Anxiety

  4. PROMIS depression [ Time Frame: 6 months ]
    Quality of life: depression

Secondary Outcome Measures :
  1. Communication [ Time Frame: 6-months ]
    Communication with providers; communication between survivor and caregiver

Other Outcome Measures:
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

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 identifier (NCT number): NCT02222337

United States, California
Latinas Contra Cancer
San Jose, California, United States, 95110
United States, District of Columbia
Nueva Vida
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
Sponsors and Collaborators
Georgetown University
Nueva Vida, Inc.
Latinas Contra Cancer
Gilda's Club New York City
Principal Investigator: Kristi D Graves, Ph.D. Georgetown University

Additional Information:
Responsible Party: Kristi Graves, PhD, Associate Professor, Georgetown University Identifier: NCT02222337     History of Changes
Other Study ID Numbers: AD-13-5635
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Kristi Graves, PhD, Georgetown University:
behavioral intervention
quality of life
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases