Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers

NCT02222337 | Completed Results DMC

• 1 other identifier: AD-13-5635
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 4

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.

Conditions

Quality of Life; Breast Cancer

Keywords

behavioral intervention; quality of life; breast cancer; Latina; caregiver; PCORI

Outcome Measures

Primary Outcomes (5)

• PROMIS Physical Functioning

  Measure Quality of Life physical functioning; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-28; A higher score = higher physical functioning

  6 months

• PROMIS Satisfaction With Social Roles

  Measure Quality of Life satisfaction with social roles domain; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10; Range of the raw score = 6-30; A higher score = higher satisfaction with social roles

  6 months

• PROMIS Anxiety

  Quality of life: Anxiety; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6 to 30. A higher score = higher anxiety

  6 months

• PROMIS Depression

  Quality of life: depression; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-30; A higher score = higher depression

  6 months

• PROMIS Fatigue

  Quality of life: fatigue; 4 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 4-20; A higher score = higher fatigue

  6 months

Secondary Outcomes (3)

• Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale)

  6-months

• Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI)

  6 Months

• Satisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL)

  6-months

Study Arms (2)

Nueva Vida Intervention

ACTIVE COMPARATOR

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

Usual Care

NO INTERVENTION

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.

Interventions

Nueva Vida Intervention BEHAVIORAL

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.

Nueva Vida Intervention

Eligibility Criteria

• Age: Up to 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Georgetown University: lead
• Nueva Vida, Inc.: collaborator
• Latinas Contra Cancer: collaborator
• Gilda's Club NYC: collaborator
• SHARE: collaborator

Study Sites (4)

Latinas Contra Cancer

San Jose, California, 95110, United States

Location

Nueva Vida

Washington D.C., District of Columbia, 20007, United States

Location

Gilda's Club New York City

New York, New York, 10014, United States

Location

SHARE

New York, New York, 95110, United States

Location

Related Publications (1)

• 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.

  PMID: 25377349 BACKGROUND

Related Links

• Description of the project on the Patient Centered Outcomes Research Institute (PCORI) website

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Difficulty tracking all approached and eligible participants in terms of number of individuals who declined the study due to recruitment at multiple community events and community sites.

Results Point of Contact

• Title: Kristi Graves, PhD
• Organization: Lombardi Comprehensive Cancer Center, Georgetown University

Kristi.Graves@georgetown.edu

202-687-1591

Study Officials

• Kristi D Graves, Ph.D.

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 21, 2014
• Study Start: May 1, 2013
• Primary Completion: January 24, 2017
• Study Completion: December 1, 2017
• Last Updated: June 3, 2019
• Results First Posted: June 3, 2019

Record last verified: 2019-02

Locations

US (4)