Trial Outcomes & Findings for Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers (NCT NCT02222337)

Last Updated: 2019-06-03

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

272 participants

Primary outcome timeframe

6 months

Results posted on

2019-06-03

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	140	132
Overall Study COMPLETED	114	108
Overall Study NOT COMPLETED	26	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Baseline analysis was conducted by 1) randomization, and 2) participant type. Thus, although there were 140 intervention participants and 130 usual care participants, these groups were separated further to be analyzed by survivor and caregiver status. Further, data was missing for certain measures; numbers analyzed are adjusted accordingly.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6 months

Population: Cancer survivors

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

Outcome measures

Outcome measures
Measure	Usual Care Survivors n=57 Participants 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.	Usual Care Caregivers n=51 Participants 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.	Nueva Vida Intervetion Survivors n=57 Participants 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.	Nueva Vida Intervention Caregivers n=57 Participants 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.
PROMIS Physical Functioning	44.61 units on a scale Standard Deviation 8.71	53.82 units on a scale Standard Deviation 7.34	45.07 units on a scale Standard Deviation 9.20	52.99 units on a scale Standard Deviation 7.70

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Usual Care Survivors n=57 Participants 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.	Usual Care Caregivers n=51 Participants 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.	Nueva Vida Intervetion Survivors n=57 Participants 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.	Nueva Vida Intervention Caregivers n=57 Participants 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.
PROMIS Satisfaction With Social Roles	52.84 units on a scale Standard Deviation 10.11	58.64 units on a scale Standard Deviation 5.93	54.07 units on a scale Standard Deviation 9.87	59.45 units on a scale Standard Deviation 6.75

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Usual Care Survivors n=57 Participants 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.	Usual Care Caregivers n=51 Participants 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.	Nueva Vida Intervetion Survivors n=57 Participants 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.	Nueva Vida Intervention Caregivers n=57 Participants 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.
PROMIS Anxiety	53.93 units on a scale Standard Deviation 12.04	48.41 units on a scale Standard Deviation 8.61	50.90 units on a scale Standard Deviation 11.99	48.70 units on a scale Standard Deviation 8.76

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Usual Care Survivors n=57 Participants 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.	Usual Care Caregivers n=51 Participants 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.	Nueva Vida Intervetion Survivors n=57 Participants 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.	Nueva Vida Intervention Caregivers n=57 Participants 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.
PROMIS Depression	47.43 units on a scale Standard Deviation 9.46	43.95 units on a scale Standard Deviation 7.16	47.35 units on a scale Standard Deviation 11.13	44.49 units on a scale Standard Deviation 7.48

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Usual Care Survivors n=57 Participants 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.	Usual Care Caregivers n=51 Participants 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.	Nueva Vida Intervetion Survivors n=57 Participants 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.	Nueva Vida Intervention Caregivers n=57 Participants 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.
PROMIS Fatigue	49.07 units on a scale Standard Deviation 12.85	53.06 units on a scale Standard Deviation 12.38	47.83 units on a scale Standard Deviation 10.48	46.68 units on a scale Standard Deviation 10.77

SECONDARY outcome

Timeframe: 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.

Communication with providers in terms of overall satisfaction with communication. Range for subscale is 1-5; higher scores indicate higher communication satisfaction.

Outcome measures

Outcome measures
Measure	Usual Care Survivors n=70 Participants 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.	Usual Care Caregivers n=65 Participants 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.	Nueva Vida Intervetion Survivors 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.	Nueva Vida Intervention Caregivers 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.
Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale)	3.52 units on a scale Standard Deviation 1.94	3.23 units on a scale Standard Deviation 1.69	—	—

SECONDARY outcome

Timeframe: 6 Months

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

Outcome measures

Outcome measures
Measure	Usual Care Survivors n=70 Participants 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.	Usual Care Caregivers n=65 Participants 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.	Nueva Vida Intervetion Survivors 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.	Nueva Vida Intervention Caregivers 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.
Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI)	106.96 units on a scale Standard Deviation 19.59	107.96 units on a scale Standard Deviation 17.35	—	—

SECONDARY outcome

Timeframe: 6-months

Satisfaction with health care received by the breast cancer survivor from her oncology health care providers or general health care providers

Outcome measures

Outcome measures
Measure	Usual Care Survivors n=70 Participants 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.	Usual Care Caregivers n=65 Participants 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.	Nueva Vida Intervetion Survivors 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.	Nueva Vida Intervention Caregivers 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.
Satisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL)	35.04 units on a scale Standard Deviation 4.48	34.63 units on a scale Standard Deviation 4.38	—	—

Adverse Events

Nueva Vida Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kristi Graves, PhD

Lombardi Comprehensive Cancer Center, Georgetown University

Phone: 202-687-1591

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place