Breast Cancer, Quality of Life
Conditions
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
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
Study design
Eligibility
Inclusion criteria
* Survivors: Latina, has been diagnosed with breast cancer, speaks English or Spanish, has a Caregiver who is willing to participate. * Caregivers: a primary caregiver for a Latina breast cancer survivor, speak English or Spanish
Exclusion criteria
1. Inability to understand spoken English and/or Spanish and/or 2. Cognitive impairment that precludes informed consent (determined by the PIs or Co-Investigators who are mental health professionals).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 270 |
Baseline characteristics
| Characteristic | Nueva Vida Intervention | Usual Care | Total |
|---|---|---|---|
| Age, Categorical Caregivers <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Caregivers >=65 years | 6 Participants | 6 Participants | 12 Participants |
| Age, Categorical Caregivers Between 18 and 65 years | 61 Participants | 57 Participants | 118 Participants |
| Age, Categorical Survivors <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Survivors >=65 years | 10 Participants | 9 Participants | 19 Participants |
| Age, Categorical Survivors Between 18 and 65 years | 59 Participants | 56 Participants | 115 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 Participants | 64 Participants | 133 Participants |
| Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Survivors Hispanic or Latino | 70 Participants | 65 Participants | 135 Participants |
| Ethnicity (NIH/OMB) Survivors Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Survivors Unknown or Not Reported | 0 Participants | 0 Participants | 0 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 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Caregivers More than one race | 25 Participants | 22 Participants | 47 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 26 Participants | 21 Participants | 47 Participants |
| Race (NIH/OMB) Caregivers White | 19 Participants | 21 Participants | 40 Participants |
| Race (NIH/OMB) Survivors American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Survivors Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Survivors Black or African American | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Survivors More than one race | 28 Participants | 31 Participants | 59 Participants |
| Race (NIH/OMB) Survivors Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Survivors Unknown or Not Reported | 17 Participants | 11 Participants | 28 Participants |
| Race (NIH/OMB) Survivors White | 22 Participants | 17 Participants | 39 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 Participants | 38 Participants | 80 Participants |
| Sex: Female, Male Caregivers Male | 28 Participants | 27 Participants | 55 Participants |
| Sex: Female, Male Survivors Female | 70 Participants | 65 Participants | 135 Participants |
| Sex: Female, Male Survivors Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 140 | 2 / 130 |
| other Total, other adverse events | 0 / 140 | 0 / 130 |
| serious Total, serious adverse events | 0 / 140 | 0 / 130 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Survivors | PROMIS Anxiety | 53.93 units on a scale | Standard Deviation 12.04 |
| Usual Care Caregivers | PROMIS Anxiety | 48.41 units on a scale | Standard Deviation 8.61 |
| Nueva Vida Intervetion Survivors | PROMIS Anxiety | 50.90 units on a scale | Standard Deviation 11.99 |
| Nueva Vida Intervention Caregivers | PROMIS Anxiety | 48.70 units on a scale | Standard Deviation 8.76 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Survivors | PROMIS Depression | 47.43 units on a scale | Standard Deviation 9.46 |
| Usual Care Caregivers | PROMIS Depression | 43.95 units on a scale | Standard Deviation 7.16 |
| Nueva Vida Intervetion Survivors | PROMIS Depression | 47.35 units on a scale | Standard Deviation 11.13 |
| Nueva Vida Intervention Caregivers | PROMIS Depression | 44.49 units on a scale | Standard Deviation 7.48 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Survivors | PROMIS Fatigue | 49.07 units on a scale | Standard Deviation 12.85 |
| Usual Care Caregivers | PROMIS Fatigue | 53.06 units on a scale | Standard Deviation 12.38 |
| Nueva Vida Intervetion Survivors | PROMIS Fatigue | 47.83 units on a scale | Standard Deviation 10.48 |
| Nueva Vida Intervention Caregivers | PROMIS Fatigue | 46.68 units on a scale | Standard Deviation 10.77 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Survivors | PROMIS Physical Functioning | 44.61 units on a scale | Standard Deviation 8.71 |
| Usual Care Caregivers | PROMIS Physical Functioning | 53.82 units on a scale | Standard Deviation 7.34 |
| Nueva Vida Intervetion Survivors | PROMIS Physical Functioning | 45.07 units on a scale | Standard Deviation 9.2 |
| Nueva Vida Intervention Caregivers | PROMIS Physical Functioning | 52.99 units on a scale | Standard Deviation 7.7 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Survivors | PROMIS Satisfaction With Social Roles | 52.84 units on a scale | Standard Deviation 10.11 |
| Usual Care Caregivers | PROMIS Satisfaction With Social Roles | 58.64 units on a scale | Standard Deviation 5.93 |
| Nueva Vida Intervetion Survivors | PROMIS Satisfaction With Social Roles | 54.07 units on a scale | Standard Deviation 9.87 |
| Nueva Vida Intervention Caregivers | PROMIS Satisfaction With Social Roles | 59.45 units on a scale | Standard Deviation 6.75 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Survivors | Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale) | 3.52 units on a scale | Standard Deviation 1.94 |
| Usual Care Caregivers | Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale) | 3.23 units on a scale | Standard Deviation 1.69 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Survivors | Satisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL) | 35.04 units on a scale | Standard Deviation 4.48 |
| Usual Care Caregivers | Satisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL) | 34.63 units on a scale | Standard Deviation 4.38 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Survivors | Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI) | 106.96 units on a scale | Standard Deviation 19.59 |
| Usual Care Caregivers | Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI) | 107.96 units on a scale | Standard Deviation 17.35 |