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Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers

Nueva Vida Intervention: Improving QOL in Latina Breast Cancer Survivors and Their Caregivers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02222337
Enrollment
272
Registered
2014-08-21
Start date
2013-05-31
Completion date
2017-12-31
Last updated
2019-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Quality of Life

Keywords

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

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.

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.

Interventions

BEHAVIORALNueva 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.

Sponsors

Nueva Vida, Inc.
CollaboratorINDUSTRY
Latinas Contra Cancer
CollaboratorUNKNOWN
Gilda's Club NYC
CollaboratorOTHER
SHARE
CollaboratorUNKNOWN
Georgetown University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 85 Years
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).

Design outcomes

Primary

MeasureTime frameDescription
PROMIS Fatigue6 monthsQuality 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
PROMIS Satisfaction With Social Roles6 monthsMeasure 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
PROMIS Anxiety6 monthsQuality 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
PROMIS Depression6 monthsQuality 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
PROMIS Physical Functioning6 monthsMeasure 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

Secondary

MeasureTime frameDescription
Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI)6 MonthsSelf-efficacy; cancer survivors' confidence in coping with cancer and its treatment
Satisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL)6-monthsSatisfaction with health care received by the breast cancer survivor from her oncology health care providers or general health care providers
Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale)6-monthsCommunication with providers in terms of overall satisfaction with communication. Range for subscale is 1-5; higher scores indicate higher communication satisfaction.

Countries

United States

Participant flow

Pre-assignment details

We reconciled the prior enrollment number in the Protocol Section (i.e., 272) that had conflicted with the number of participants started in the Participant Flow module (i.e., 270). The discrepancy was because two participants enrolled but withdrew prior to the baseline interview. We thus did not have any data on these 2 participants.

Participants by arm

ArmCount
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. 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 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.
140
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.
130
Total270

Baseline characteristics

CharacteristicNueva Vida InterventionUsual CareTotal
Age, Categorical
Caregivers
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
Caregivers
>=65 years
6 Participants6 Participants12 Participants
Age, Categorical
Caregivers
Between 18 and 65 years
61 Participants57 Participants118 Participants
Age, Categorical
Survivors
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
Survivors
>=65 years
10 Participants9 Participants19 Participants
Age, Categorical
Survivors
Between 18 and 65 years
59 Participants56 Participants115 Participants
Communication - Patient Satisfaction with Care (PSQ-18 Communication Subscale)2.28 units on a scale
STANDARD_DEVIATION 0.91
2.28 units on a scale
STANDARD_DEVIATION 0.93
2.28 units on a scale
STANDARD_DEVIATION 0.92
Ethnicity (NIH/OMB)
Caregivers
Hispanic or Latino
69 Participants64 Participants133 Participants
Ethnicity (NIH/OMB)
Caregivers
Not Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Caregivers
Unknown or Not Reported
1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Survivors
Hispanic or Latino
70 Participants65 Participants135 Participants
Ethnicity (NIH/OMB)
Survivors
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Survivors
Unknown or Not Reported
0 Participants0 Participants0 Participants
PROMIS Anxiety
Caregivers
51.9 units on a scale
STANDARD_DEVIATION 9.76
50.35 units on a scale
STANDARD_DEVIATION 9.26
51.15 units on a scale
STANDARD_DEVIATION 9.52
PROMIS Anxiety
Survivors
54.3 units on a scale
STANDARD_DEVIATION 12.97
52.94 units on a scale
STANDARD_DEVIATION 9.95
53.65 units on a scale
STANDARD_DEVIATION 11.59
PROMIS Depression
Caregivers
46.72 units on a scale
STANDARD_DEVIATION 9.32
45.10 units on a scale
STANDARD_DEVIATION 8.24
45.94 units on a scale
STANDARD_DEVIATION 8.82
PROMIS Depression
Survivors
51.35 units on a scale
STANDARD_DEVIATION 12.11
48.22 units on a scale
STANDARD_DEVIATION 9.52
49.84 units on a scale
STANDARD_DEVIATION 11.01
PROMIS Fatigue
Caregivers
45.12 units on a scale
STANDARD_DEVIATION 11.24
44.14 units on a scale
STANDARD_DEVIATION 9.95
44.64 units on a scale
STANDARD_DEVIATION 10.61
PROMIS Fatigue
Survivors
52.95 units on a scale
STANDARD_DEVIATION 13.03
49.57 units on a scale
STANDARD_DEVIATION 11.99
51.33 units on a scale
STANDARD_DEVIATION 12.61
PROMIS Physical Functioning
Caregivers
53.71 units on a scale
STANDARD_DEVIATION 7.54
53.72 units on a scale
STANDARD_DEVIATION 7.14
53.72 units on a scale
STANDARD_DEVIATION 7.32
PROMIS Physical Functioning
Survivors
44.14 units on a scale
STANDARD_DEVIATION 9.15
44.33 units on a scale
STANDARD_DEVIATION 9.64
44.23 units on a scale
STANDARD_DEVIATION 9.35
PROMIS Satisfaction With Social Roles
Caregivers
55.18 units on a scale
STANDARD_DEVIATION 8.09
55.36 units on a scale
STANDARD_DEVIATION 7.88
55.27 units on a scale
STANDARD_DEVIATION 7.96
PROMIS Satisfaction With Social Roles
Survivors
47.79 units on a scale
STANDARD_DEVIATION 7.67
48.99 units on a scale
STANDARD_DEVIATION 7.71
48.37 units on a scale
STANDARD_DEVIATION 7.68
Race (NIH/OMB)
Caregivers
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Caregivers
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Caregivers
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Caregivers
More than one race
25 Participants22 Participants47 Participants
Race (NIH/OMB)
Caregivers
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Caregivers
Unknown or Not Reported
26 Participants21 Participants47 Participants
Race (NIH/OMB)
Caregivers
White
19 Participants21 Participants40 Participants
Race (NIH/OMB)
Survivors
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Survivors
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Survivors
Black or African American
3 Participants5 Participants8 Participants
Race (NIH/OMB)
Survivors
More than one race
28 Participants31 Participants59 Participants
Race (NIH/OMB)
Survivors
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Survivors
Unknown or Not Reported
17 Participants11 Participants28 Participants
Race (NIH/OMB)
Survivors
White
22 Participants17 Participants39 Participants
Satisfaction with Care Experience of Care and Health Outcomes (ECHOS-NHL)33.68 units on a scale
STANDARD_DEVIATION 5.87
34.35 units on a scale
STANDARD_DEVIATION 4.88
34 units on a scale
STANDARD_DEVIATION 5.41
Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI)100.07 units on a scale
STANDARD_DEVIATION 21.28
101.60 units on a scale
STANDARD_DEVIATION 19.11
100.81 units on a scale
STANDARD_DEVIATION 20.2
Sex: Female, Male
Caregivers
Female
42 Participants38 Participants80 Participants
Sex: Female, Male
Caregivers
Male
28 Participants27 Participants55 Participants
Sex: Female, Male
Survivors
Female
70 Participants65 Participants135 Participants
Sex: Female, Male
Survivors
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 1402 / 130
other
Total, other adverse events
0 / 1400 / 130
serious
Total, serious adverse events
0 / 1400 / 130

Outcome results

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

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Usual Care SurvivorsPROMIS Anxiety53.93 units on a scaleStandard Deviation 12.04
Usual Care CaregiversPROMIS Anxiety48.41 units on a scaleStandard Deviation 8.61
Nueva Vida Intervetion SurvivorsPROMIS Anxiety50.90 units on a scaleStandard Deviation 11.99
Nueva Vida Intervention CaregiversPROMIS Anxiety48.70 units on a scaleStandard Deviation 8.76
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

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Usual Care SurvivorsPROMIS Depression47.43 units on a scaleStandard Deviation 9.46
Usual Care CaregiversPROMIS Depression43.95 units on a scaleStandard Deviation 7.16
Nueva Vida Intervetion SurvivorsPROMIS Depression47.35 units on a scaleStandard Deviation 11.13
Nueva Vida Intervention CaregiversPROMIS Depression44.49 units on a scaleStandard Deviation 7.48
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

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Usual Care SurvivorsPROMIS Fatigue49.07 units on a scaleStandard Deviation 12.85
Usual Care CaregiversPROMIS Fatigue53.06 units on a scaleStandard Deviation 12.38
Nueva Vida Intervetion SurvivorsPROMIS Fatigue47.83 units on a scaleStandard Deviation 10.48
Nueva Vida Intervention CaregiversPROMIS Fatigue46.68 units on a scaleStandard Deviation 10.77
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

Time frame: 6 months

Population: Cancer survivors

ArmMeasureValue (MEAN)Dispersion
Usual Care SurvivorsPROMIS Physical Functioning44.61 units on a scaleStandard Deviation 8.71
Usual Care CaregiversPROMIS Physical Functioning53.82 units on a scaleStandard Deviation 7.34
Nueva Vida Intervetion SurvivorsPROMIS Physical Functioning45.07 units on a scaleStandard Deviation 9.2
Nueva Vida Intervention CaregiversPROMIS Physical Functioning52.99 units on a scaleStandard Deviation 7.7
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

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Usual Care SurvivorsPROMIS Satisfaction With Social Roles52.84 units on a scaleStandard Deviation 10.11
Usual Care CaregiversPROMIS Satisfaction With Social Roles58.64 units on a scaleStandard Deviation 5.93
Nueva Vida Intervetion SurvivorsPROMIS Satisfaction With Social Roles54.07 units on a scaleStandard Deviation 9.87
Nueva Vida Intervention CaregiversPROMIS Satisfaction With Social Roles59.45 units on a scaleStandard Deviation 6.75
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.

Time frame: 6-months

Population: Some participants passed away, withdrew, or were lost to follow up after baseline. Data was missing for certain measures; numbers analyzed are adjusted accordingly. Analysis was conducted by 1) randomization, and 2) participant type.

ArmMeasureValue (MEAN)Dispersion
Usual Care SurvivorsCommunication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale)3.52 units on a scaleStandard Deviation 1.94
Usual Care CaregiversCommunication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale)3.23 units on a scaleStandard Deviation 1.69
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

Time frame: 6-months

Population: Some participants passed away, withdrew, or were lost to follow up after baseline. Data was missing for certain measures; numbers analyzed are adjusted accordingly. Analysis was conducted by 1) randomization, and 2) participant type.

ArmMeasureValue (MEAN)Dispersion
Usual Care SurvivorsSatisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL)35.04 units on a scaleStandard Deviation 4.48
Usual Care CaregiversSatisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL)34.63 units on a scaleStandard Deviation 4.38
Secondary

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

Self-efficacy; cancer survivors' confidence in coping with cancer and its treatment

Time frame: 6 Months

Population: Some participants passed away, withdrew, or were lost to follow up after baseline. Data was missing for certain measures; numbers analyzed are adjusted accordingly. Analysis was conducted by 1) randomization, and 2) participant type.

ArmMeasureValue (MEAN)Dispersion
Usual Care SurvivorsSelf-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI)106.96 units on a scaleStandard Deviation 19.59
Usual Care CaregiversSelf-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI)107.96 units on a scaleStandard Deviation 17.35

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026