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研究方案:一项针对非裔美国家庭共同应对父母癌症的随机对照试验。

Study protocol: a randomized control trial of African American families fighting parental cancer together.

机构信息

School of Nursing, University of Delaware, 381 McDowell Hall, 25 N. College Ave, Newark, DE, 19716, USA.

Helen F. Graham Cancer Center & Research Institute, Christiana Care Health System, 4701 Ogletown-Stanton Road, Suite 2200, Newark, DE, 19713, USA.

出版信息

BMC Cancer. 2018 Nov 20;18(1):1140. doi: 10.1186/s12885-018-5052-8.

Abstract

BACKGROUND

African American adults experience a disproportionate burden and increased mortality for most solid tumor cancers and their adolescent children are negatively impacted by the illness experience. The purpose of this randomized clinical trial is to evaluate the efficacy of a culturally sensitive family-based intervention program developed for African American families coping with solid tumor parental cancer using an intention-to-treat approach. Primary outcome is adolescent depressive symptoms at end of treatment.

METHODS

A sample of 172 African American families will be enrolled from two diverse oncology centers (Helen Graham Cancer Center in Newark, DE, and Kimmel Cancer Center in Philadelphia, PA). Eligible families will be randomized either to a 5-session intervention Families Fighting Cancer Together (FFCT) or a 5-session parent-only psycho-educational (PED) program. Assessments will occur at weeks 0 (baseline), 8 (end-of-treatment), 24, and 52.

DISCUSSION

Treatments to help African American adolescents cope with the impact of parental cancer are scarce and urgently needed. If successful, this proposed research will change the nature of intervention support options available to African Americans, who are overrepresented and underserved by existing services or programs.

TRIAL REGISTRATION

This project is registered with ClinicalTrials.gov (Protocol #: NCT03567330).

摘要

背景

非裔美国成年人在大多数实体瘤癌症中承受着不成比例的负担和更高的死亡率,他们的青少年子女也受到疾病经历的负面影响。本随机临床试验的目的是评估一种针对非裔美国家庭的基于家庭的干预方案的疗效,该方案针对的是正在应对父母患有实体瘤的非裔美国家庭,采用意向治疗方法。主要结局是治疗结束时青少年的抑郁症状。

方法

将从两个不同的肿瘤中心(特拉华州纽瓦克的海伦·格雷厄姆癌症中心和宾夕法尼亚州费城的金梅尔癌症中心)招募 172 个非裔美国家庭。符合条件的家庭将随机分配到 5 节干预课程“一起抗癌的家庭”(FFCT)或 5 节父母单独的心理教育课程(PED)。评估将在第 0 周(基线)、第 8 周(治疗结束)、第 24 周和第 52 周进行。

讨论

帮助非裔美国青少年应对父母癌症影响的治疗方法非常匮乏,急需开展相关研究。如果成功,这项研究将改变非裔美国人可获得的干预支持选择的性质,他们在现有的服务或项目中代表性不足,服务不足。

试验注册

该项目在 ClinicalTrials.gov 注册(协议编号:NCT03567330)。

相似文献

本文引用的文献

1
Cancer statistics, 2018.癌症统计数据,2018 年。
CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.

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