Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers
Sponsor
Georgetown University (Other)
Overall Status
Completed
CT.gov ID
NCT02222337
Collaborator
Nueva Vida, Inc. (Industry), Latinas Contra Cancer (Other), Gilda's Club NYC (Other), SHARE (Other)
272
4
2
55
68
1.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
272 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Nueva Vida Intervention: Improving QOL in Latina Breast Cancer Survivors and Their Caregivers
Study Start Date
:
May 1, 2013
Actual Primary Completion Date
:
Jan 24, 2017
Actual Study Completion Date
:
Dec 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- PROMIS Physical Functioning [6 months]
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
- PROMIS Satisfaction With Social Roles [6 months]
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
- PROMIS Anxiety [6 months]
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
- PROMIS Depression [6 months]
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
- PROMIS Fatigue [6 months]
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
Secondary Outcome Measures
- Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale) [6-months]
Communication with providers in terms of overall satisfaction with communication. Range for subscale is 1-5; higher scores indicate higher communication satisfaction.
- Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI) [6 Months]
Self-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-months]
Satisfaction with health care received by the breast cancer survivor from her oncology health care providers or general health care providers
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 85 Years
Sexes Eligible for Study:
All
Accepts 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:
-
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Latinas Contra Cancer | San Jose | California | United States | 95110 |
| 2 | Nueva Vida | Washington | District of Columbia | United States | 20007 |
| 3 | Gilda's Club New York City | New York | New York | United States | 10014 |
| 4 | SHARE | New York | New York | United States | 95110 |
Sponsors and Collaborators
- Georgetown University
- Nueva Vida, Inc.
- Latinas Contra Cancer
- Gilda's Club NYC
- SHARE
Investigators
- Principal Investigator: Kristi D Graves, Ph.D., Georgetown University
Study Documents (Full-Text)
More Information
Additional Information:
Publications
Responsible Party:
Kristi Graves, PhD,
Associate Professor,
Georgetown University
ClinicalTrials.gov Identifier:
NCT02222337
Other Study ID Numbers:
- AD-13-5635
First Posted:
Aug 21, 2014
Last Update Posted:
Jun 3, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Kristi Graves, PhD,
Associate Professor,
Georgetown University
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Nueva Vida Intervention | Usual Care |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 140 | 132 |
| COMPLETED | 114 | 108 |
| NOT COMPLETED | 26 | 24 |
Baseline Characteristics
| Arm/Group Title | Nueva Vida Intervention | Usual Care | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | Total of all reporting groups |
| Overall Participants | 140 | 130 | 270 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
59
42.1%
|
56
43.1%
|
115
42.6%
|
| >=65 years |
10
7.1%
|
9
6.9%
|
19
7%
|
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
61
43.6%
|
57
43.8%
|
118
43.7%
|
| >=65 years |
6
4.3%
|
6
4.6%
|
12
4.4%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
70
50%
|
65
50%
|
135
50%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Female |
42
30%
|
38
29.2%
|
80
29.6%
|
| Male |
28
20%
|
27
20.8%
|
55
20.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
70
50%
|
65
50%
|
135
50%
|
| Not Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Hispanic or Latino |
69
49.3%
|
64
49.2%
|
133
49.3%
|
| Not Hispanic or Latino |
0
0%
|
1
0.8%
|
1
0.4%
|
| Unknown or Not Reported |
1
0.7%
|
0
0%
|
1
0.4%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
3
2.1%
|
5
3.8%
|
8
3%
|
| White |
22
15.7%
|
17
13.1%
|
39
14.4%
|
| More than one race |
28
20%
|
31
23.8%
|
59
21.9%
|
| Unknown or Not Reported |
17
12.1%
|
11
8.5%
|
28
10.4%
|
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
1
0.8%
|
1
0.4%
|
| White |
19
13.6%
|
21
16.2%
|
40
14.8%
|
| More than one race |
25
17.9%
|
22
16.9%
|
47
17.4%
|
| Unknown or Not Reported |
26
18.6%
|
21
16.2%
|
47
17.4%
|
| Satisfaction with Care Experience of Care and Health Outcomes (ECHOS-NHL) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
33.68
(5.87)
|
34.35
(4.88)
|
34
(5.41)
|
| Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
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) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
2.28
(0.91)
|
2.28
(0.93)
|
2.28
(0.92)
|
| PROMIS Anxiety (units on a scale) [Mean (Standard Deviation) ] | |||
| 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)
|
| PROMIS Depression (units on a scale) [Mean (Standard Deviation) ] | |||
| Survivors |
51.35
(12.11)
|
48.22
(9.52)
|
49.84
(11.01)
|
| Caregivers |
46.72
(9.32)
|
45.10
(8.24)
|
45.94
(8.82)
|
| PROMIS Fatigue (units on a scale) [Mean (Standard Deviation) ] | |||
| Survivors |
52.95
(13.03)
|
49.57
(11.99)
|
51.33
(12.61)
|
| Caregivers |
45.12
(11.24)
|
44.14
(9.95)
|
44.64
(10.61)
|
| PROMIS Physical Functioning (units on a scale) [Mean (Standard Deviation) ] | |||
| Survivors |
44.14
(9.15)
|
44.33
(9.64)
|
44.23
(9.35)
|
| Caregivers |
53.71
(7.54)
|
53.72
(7.14)
|
53.72
(7.32)
|
| PROMIS Satisfaction With Social Roles (units on a scale) [Mean (Standard Deviation) ] | |||
| Survivors |
47.79
(7.67)
|
48.99
(7.71)
|
48.37
(7.68)
|
| Caregivers |
55.18
(8.09)
|
55.36
(7.88)
|
55.27
(7.96)
|
Outcome Measures
| Title | PROMIS Physical Functioning |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cancer survivors |
| Arm/Group Title | Usual Care Survivors | Usual Care Caregivers | Nueva Vida Intervetion Survivors | Nueva Vida Intervention Caregivers |
|---|---|---|---|---|
| Arm/Group Description | Survivors randomized to 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. | Caregivers randomized to 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. | Survivors randomized to the Nueva Vida Intervention: 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. 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. | Caregivers randomized to the Nueva Vida Intervention: 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. 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. |
| Measure Participants | 57 | 51 | 57 | 57 |
| Mean (Standard Deviation) [units on a scale] |
44.61
(8.71)
|
53.82
(7.34)
|
45.07
(9.20)
|
52.99
(7.70)
|
| Title | PROMIS Satisfaction With Social Roles |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Usual Care Survivors | Usual Care Caregivers | Nueva Vida Intervetion Survivors | Nueva Vida Intervention Caregivers |
|---|---|---|---|---|
| Arm/Group Description | Survivors randomized to 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. | Caregivers randomized to 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. | Survivors randomized to the Nueva Vida Intervention: 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. 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. | Caregivers randomized to the Nueva Vida Intervention: 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. 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. |
| Measure Participants | 57 | 51 | 57 | 57 |
| Mean (Standard Deviation) [units on a scale] |
52.84
(10.11)
|
58.64
(5.93)
|
54.07
(9.87)
|
59.45
(6.75)
|
| Title | PROMIS Anxiety |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Usual Care Survivors | Usual Care Caregivers | Nueva Vida Intervetion Survivors | Nueva Vida Intervention Caregivers |
|---|---|---|---|---|
| Arm/Group Description | Survivors randomized to 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. | Caregivers randomized to 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. | Survivors randomized to the Nueva Vida Intervention: 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. 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. | Caregivers randomized to the Nueva Vida Intervention: 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. 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. |
| Measure Participants | 57 | 51 | 57 | 57 |
| Mean (Standard Deviation) [units on a scale] |
53.93
(12.04)
|
48.41
(8.61)
|
50.90
(11.99)
|
48.70
(8.76)
|
| Title | PROMIS Depression |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Usual Care Survivors | Usual Care Caregivers | Nueva Vida Intervetion Survivors | Nueva Vida Intervention Caregivers |
|---|---|---|---|---|
| Arm/Group Description | Survivors randomized to 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. | Caregivers randomized to 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. | Survivors randomized to the Nueva Vida Intervention: 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. 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. | Caregivers randomized to the Nueva Vida Intervention: 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. 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. |
| Measure Participants | 57 | 51 | 57 | 57 |
| Mean (Standard Deviation) [units on a scale] |
47.43
(9.46)
|
43.95
(7.16)
|
47.35
(11.13)
|
44.49
(7.48)
|
| Title | PROMIS Fatigue |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Usual Care Survivors | Usual Care Caregivers | Nueva Vida Intervetion Survivors | Nueva Vida Intervention Caregivers |
|---|---|---|---|---|
| Arm/Group Description | Survivors randomized to 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. | Caregivers randomized to 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. | Survivors randomized to the Nueva Vida Intervention: 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. 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. | Caregivers randomized to the Nueva Vida Intervention: 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. 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. |
| Measure Participants | 57 | 51 | 57 | 57 |
| Mean (Standard Deviation) [units on a scale] |
49.07
(12.85)
|
53.06
(12.38)
|
47.83
(10.48)
|
46.68
(10.77)
|
| Title | Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Nueva Vida Intervention | Usual Care |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 70 | 65 |
| Mean (Standard Deviation) [units on a scale] |
3.52
(1.94)
|
3.23
(1.69)
|
| Title | Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI) |
|---|---|
| Description | Self-efficacy; cancer survivors' confidence in coping with cancer and its treatment |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Nueva Vida Intervention | Usual Care |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 70 | 65 |
| Mean (Standard Deviation) [units on a scale] |
106.96
(19.59)
|
107.96
(17.35)
|
| Title | Satisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Nueva Vida Intervention | Usual Care |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 70 | 65 |
| Mean (Standard Deviation) [units on a scale] |
35.04
(4.48)
|
34.63
(4.38)
|
Adverse Events
| Time Frame | Adverse event data were collected from time of enrollment through 6-month follow-up (3 years). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Nueva Vida Intervention | Usual Care | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| Nueva Vida Intervention | Usual Care | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/140 (0.7%) | 2/130 (1.5%) | ||
Serious Adverse Events |
||||
| Nueva Vida Intervention | Usual Care | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/140 (0%) | 0/130 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Nueva Vida Intervention | Usual Care | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/140 (0%) | 0/130 (0%) | ||
Limitations/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.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Kristi Graves, PhD |
|---|---|
| Organization | Lombardi Comprehensive Cancer Center, Georgetown University |
| Phone | 202-687-1591 |
| Kristi.Graves@georgetown.edu |
Responsible Party:
Kristi Graves, PhD,
Associate Professor,
Georgetown University
ClinicalTrials.gov Identifier:
NCT02222337
Other Study ID Numbers:
- AD-13-5635
First Posted:
Aug 21, 2014
Last Update Posted:
Jun 3, 2019
Last Verified:
Feb 1, 2019