Breast Cancer Clinical Trial
Official title:
Nueva Vida Intervention: Improving QOL in Latina Breast Cancer Survivors and Their Caregivers
NCT number | NCT02222337 |
Other study ID # | AD-13-5635 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | December 2017 |
Verified date | February 2019 |
Source | Georgetown University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 272 |
Est. completion date | December 2017 |
Est. primary completion date | January 24, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 85 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
United States | Gilda's Club New York City | New York | New York |
United States | SHARE | New York | New York |
United States | Latinas Contra Cancer | San Jose | California |
United States | Nueva Vida | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Georgetown University | Gilda's Club NYC, Latinas Contra Cancer, Nueva Vida, Inc., SHARE |
United States,
Rush CL, Darling M, Elliott MG, Febus-Sampayo I, Kuo C, Muñoz J, Duron Y, Torres M, Galván CC, Gonzalez F, Caicedo L, Nápoles 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale) | Communication with providers in terms of overall satisfaction with communication. Range for subscale is 1-5; higher scores indicate higher communication satisfaction. | 6-months | |
Secondary | Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI) | Self-efficacy; cancer survivors' confidence in coping with cancer and its treatment | 6 Months | |
Secondary | Satisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL) | Satisfaction with health care received by the breast cancer survivor from her oncology health care providers or general health care providers | 6-months |
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