Nueva Vida Pilot Intervention for Latina Breast Cancer Survivors and Caregivers

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Georgetown University
Sponsor:
Collaborators:
Nueva Vida, Inc.
Latinas Contra Cancer
Gilda's Club New York City
SHARE
Information provided by (Responsible Party):
Kristi Graves, PhD, Georgetown University
ClinicalTrials.gov Identifier:
NCT02222337
First received: August 19, 2014
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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 Intervention
Quality of Life
Breast Cancer
Behavioral: Nueva Vida Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Nueva Vida Intervention: Improving QOL in Latina Breast Cancer Survivors and Their Caregivers

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Patient Reported Outcomes Measurement Information System (PROMIS) physical functioning [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measure Quality of Life physical functioning

  • PROMIS satisfaction with social roles [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Quality of Life: social roles

  • PROMIS anxiety [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Quality of life: Anxiety

  • PROMIS depression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Quality of life: depression


Secondary Outcome Measures:
  • Communication [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    Communication with providers; communication between survivor and caregiver


Other Outcome Measures:
  • Satisfaction with Care [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    Satisfaction with health care received by the breast cancer survivor from her oncology health care providers or general health care providers


Estimated Enrollment: 250
Study Start Date: May 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02222337

Contacts
Contact: Kristi Graves, Ph.D. 202-687-1591 Kristi.Graves@georgetown.edu
Contact: Christina Rush, M.A. Christina.Rush@georgetown.edu

Locations
United States, California
Latinas Contra Cancer Recruiting
San Jose, California, United States, 95110
Contact: Ysabel Duron    408-280-0811    CEO@latinascontracancer.org   
United States, District of Columbia
Nueva Vida Recruiting
Washington, District of Columbia, United States, 20007
Contact: Margaret Darling    202-223-9100    mdarling@nueva-vida.org   
United States, New York
Gilda's Club New York City Recruiting
New York, New York, United States, 10014
Contact: Migdalia Torres    212-647-9700    mtorres@gildasclubnyc.org   
SHARE Recruiting
New York, New York, United States, 95110
Contact: Ivis Sampayo    845-282-0614    isampayo@sharecancersupport.org   
Sponsors and Collaborators
Georgetown University
Nueva Vida, Inc.
Latinas Contra Cancer
Gilda's Club New York City
SHARE
Investigators
Principal Investigator: Kristi D Graves, Ph.D. Georgetown University
  More Information

Additional Information:
No publications provided

Responsible Party: Kristi Graves, PhD, Assistant Professor, Georgetown University
ClinicalTrials.gov Identifier: NCT02222337     History of Changes
Other Study ID Numbers: AD-13-5635
Study First Received: August 19, 2014
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
behavioral intervention
quality of life
breast cancer
Latina
caregiver
PCORI

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

ClinicalTrials.gov processed this record on October 29, 2014