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Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers

2019年2月20日 更新者:Kristi Graves, PhD、Georgetown University

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

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.

調査の概要

状態

完了

詳細な説明

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.

研究の種類

介入

入学 (実際)

272

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • California
      • San Jose、California、アメリカ、95110
        • Latinas Contra Cancer
    • District of Columbia
      • Washington、District of Columbia、アメリカ、20007
        • Nueva Vida
    • New York
      • New York、New York、アメリカ、10014
        • Gilda's Club New York City
      • New York、New York、アメリカ、95110
        • SHARE

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

85年歳未満 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ: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.
介入なし: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
PROMIS Physical Functioning
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale)
時間枠: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)
時間枠: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)
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Kristi D Graves, Ph.D.、Georgetown University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2013年5月1日

一次修了 (実際)

2017年1月24日

研究の完了 (実際)

2017年12月1日

試験登録日

最初に提出

2014年8月19日

QC基準を満たした最初の提出物

2014年8月20日

最初の投稿 (見積もり)

2014年8月21日

学習記録の更新

投稿された最後の更新 (実際)

2019年6月3日

QC基準を満たした最後の更新が送信されました

2019年2月20日

最終確認日

2019年2月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • AD-13-5635

個々の参加者データ (IPD) の計画

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未定

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