- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02222337
Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers
Nueva Vida Intervention: Improving QOL in Latina Breast Cancer Survivors and Their Caregivers
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
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San Jose, California, Förenta staterna, 95110
- Latinas Contra Cancer
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 20007
- Nueva Vida
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New York
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New York, New York, Förenta staterna, 10014
- Gilda's Club New York City
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New York, New York, Förenta staterna, 95110
- SHARE
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
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.
|
|
Inget ingripande: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
PROMIS Physical Functioning
Tidsram: 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
|
6 months
|
|
PROMIS Satisfaction With Social Roles
Tidsram: 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
|
6 months
|
|
PROMIS Anxiety
Tidsram: 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
|
6 months
|
|
PROMIS Depression
Tidsram: 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
|
6 months
|
|
PROMIS Fatigue
Tidsram: 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
|
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale)
Tidsram: 6-months
|
Communication with providers in terms of overall satisfaction with communication.
Range for subscale is 1-5; higher scores indicate higher communication satisfaction.
|
6-months
|
|
Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI)
Tidsram: 6 Months
|
Self-efficacy; cancer survivors' confidence in coping with cancer and its treatment
|
6 Months
|
|
Satisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL)
Tidsram: 6-months
|
Satisfaction with health care received by the breast cancer survivor from her oncology health care providers or general health care providers
|
6-months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Kristi D Graves, Ph.D., Georgetown University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AD-13-5635
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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