An interventional study of Nueva Vida Intervention in Quality of Life and Breast Cancer, sponsored by Georgetown University. Completed at 4 sites in United States. Open to participants aged Up to 85 Years. Per ClinicalTrials.gov, last updated 2019-06-03.
Sponsored by Georgetown University · Not applicable, Interventional, and Supportive care
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 272 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
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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 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.
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.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months
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.
Time frame: 6-months
Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI)
Self-efficacy; cancer survivors' confidence in coping with cancer and its treatment
Time frame: 6 Months
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
Time frame: 6-months
| Milestone | Nueva Vida Intervention | Usual Care |
|---|---|---|
| Started | 140 | 132 |
| Completed | 114 | 108 |
| Not completed | 26 | 24 |
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
| units on a scale | Usual Care Survivors | Usual Care Caregivers | Nueva Vida Intervetion Survivors | Nueva Vida Intervention Caregivers |
|---|---|---|---|---|
| PROMIS Physical Functioning | 44.61 ± 8.71 | 53.82 ± 7.34 | 45.07 ± 9.20 | 52.99 ± 7.70 |
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
| units on a scale | Usual Care Survivors | Usual Care Caregivers | Nueva Vida Intervetion Survivors | Nueva Vida Intervention Caregivers |
|---|---|---|---|---|
| PROMIS Satisfaction With Social Roles | 52.84 ± 10.11 | 58.64 ± 5.93 | 54.07 ± 9.87 | 59.45 ± 6.75 |
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
| units on a scale | Usual Care Survivors | Usual Care Caregivers | Nueva Vida Intervetion Survivors | Nueva Vida Intervention Caregivers |
|---|---|---|---|---|
| PROMIS Anxiety | 53.93 ± 12.04 | 48.41 ± 8.61 | 50.90 ± 11.99 | 48.70 ± 8.76 |
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
| units on a scale | Usual Care Survivors | Usual Care Caregivers | Nueva Vida Intervetion Survivors | Nueva Vida Intervention Caregivers |
|---|---|---|---|---|
| PROMIS Depression | 47.43 ± 9.46 | 43.95 ± 7.16 | 47.35 ± 11.13 | 44.49 ± 7.48 |
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
| units on a scale | Usual Care Survivors | Usual Care Caregivers | Nueva Vida Intervetion Survivors | Nueva Vida Intervention Caregivers |
|---|---|---|---|---|
| PROMIS Fatigue | 49.07 ± 12.85 | 53.06 ± 12.38 | 47.83 ± 10.48 | 46.68 ± 10.77 |
Communication with providers in terms of overall satisfaction with communication. Range for subscale is 1-5; higher scores indicate higher communication satisfaction.
| units on a scale | Nueva Vida Intervention | Usual Care |
|---|---|---|
| Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale) | 3.52 ± 1.94 | 3.23 ± 1.69 |
Self-efficacy; cancer survivors' confidence in coping with cancer and its treatment
| units on a scale | Nueva Vida Intervention | Usual Care |
|---|---|---|
| Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI) | 106.96 ± 19.59 | 107.96 ± 17.35 |
Satisfaction with health care received by the breast cancer survivor from her oncology health care providers or general health care providers
| units on a scale | Nueva Vida Intervention | Usual Care |
|---|---|---|
| Satisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL) | 35.04 ± 4.48 | 34.63 ± 4.38 |
Collected over Adverse event data were collected from time of enrollment through 6-month follow-up (3 years).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nueva Vida Intervention | 1/140 (0.7%) | 0/140 (0%) | 0/140 (0%) |
| Usual Care | 2/130 (1.5%) | 0/130 (0%) | 0/130 (0%) |
Two participants enrolled in the study but withdrew prior to the baseline interview (thus, N = 130). Baseline analysis was conducted by 1) randomization, and 2) participant type. Data was missing for certain measures; numbers analyzed are adjusted accordingly.
| Age, Categorical(Participants) | Nueva Vida Intervention | Usual Care | Total |
|---|---|---|---|
| Survivors — <=18 years | 0 | 0 | 0 |
| Survivors — Between 18 and 65 years | 59 | 56 | 115 |
| Survivors — >=65 years | 10 | 9 | 19 |
| Caregivers — <=18 years | 0 | 0 | 0 |
| Caregivers — Between 18 and 65 years | 61 | 57 | 118 |
| Caregivers — >=65 years | 6 | 6 | 12 |
| Sex: Female, Male(Participants) | Nueva Vida Intervention | Usual Care | Total |
|---|---|---|---|
| Survivors — Female | 70 | 65 | 135 |
| Survivors — Male | 0 | 0 | 0 |
| Caregivers — Female | 42 | 38 | 80 |
| Caregivers — Male | 28 | 27 | 55 |
| Ethnicity (NIH/OMB)(Participants) | Nueva Vida Intervention | Usual Care | Total |
|---|---|---|---|
| Survivors — Hispanic or Latino | 70 | 65 | 135 |
| Survivors — Not Hispanic or Latino | 0 | 0 | 0 |
| Survivors — Unknown or Not Reported | 0 | 0 | 0 |
| Caregivers — Hispanic or Latino | 69 | 64 | 133 |
| Caregivers — Not Hispanic or Latino | 0 | 1 | 1 |
| Caregivers — Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Nueva Vida Intervention | Usual Care | Total |
|---|---|---|---|
| Survivors — American Indian or Alaska Native | 0 | 0 | 0 |
| Survivors — Asian | 0 | 0 | 0 |
| Survivors — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Survivors — Black or African American | 3 | 5 | 8 |
| Survivors — White | 22 | 17 | 39 |
| Survivors — More than one race | 28 | 31 | 59 |
| Survivors — Unknown or Not Reported | 17 | 11 | 28 |
| Caregivers — American Indian or Alaska Native | 0 | 0 | 0 |
| Caregivers — Asian | 0 | 0 | 0 |
| Caregivers — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Caregivers — Black or African American | 0 | 1 | 1 |
| Caregivers — White | 19 | 21 | 40 |
| Caregivers — More than one race | 25 | 22 | 47 |
| Caregivers — Unknown or Not Reported | 26 | 21 | 47 |
| Satisfaction with Care Experience of Care and Health Outcomes (ECHOS-NHL)(units on a scale) | Nueva Vida Intervention | Usual Care | Total |
|---|---|---|---|
| Mean | 33.68 ± 5.87 | 34.35 ± 4.88 | 34 ± 5.41 |
| Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI)(units on a scale) | Nueva Vida Intervention | Usual Care | Total |
|---|---|---|---|
| Mean | 100.07 ± 21.28 | 101.60 ± 19.11 | 100.81 ± 20.2 |
| Communication - Patient Satisfaction with Care (PSQ-18 Communication Subscale)(units on a scale) | Nueva Vida Intervention | Usual Care | Total |
|---|---|---|---|
| Mean | 2.28 ± 0.91 | 2.28 ± 0.93 | 2.28 ± 0.92 |
| PROMIS Anxiety(units on a scale) | Nueva Vida Intervention | Usual Care | Total |
|---|---|---|---|
| Survivors | 54.3 ± 12.97 | 52.94 ± 9.95 | 53.65 ± 11.59 |
| Caregivers | 51.9 ± 9.76 | 50.35 ± 9.26 | 51.15 ± 9.52 |
4 further baseline measures are reported on the registry.
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