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

Nicole S McKinney, Shannon Virtue, Frances Marcus Lewis, Alliric I Willis, Tanisha Pettyjohn, La-Rhonda Harmon, Adam Davey, Nicole S McKinney, Shannon Virtue, Frances Marcus Lewis, Alliric I Willis, Tanisha Pettyjohn, La-Rhonda Harmon, Adam Davey

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).

Keywords: African Americans; adolescent.; cancer.; intervention groups.; randomized control trial.; solid tumor..

Conflict of interest statement

Ethics approval and consent to participate

The University of Delaware Institutional Review Board approved this research trial (Protocol # 1165185–1) and served as the single IRB of record, consistent with National Institutes of Health NOT-OD-16-094 (https://grants.nih.gov/grants/guide/notice-files/not-od-16-094.html). Helen F. Graham Cancer Center of Christiana Care Hospital System (Dr. Shannon Virtue, site PI) and Sidney Kimmel Cancer Center of Jefferson University (Dr. Alliric Willis, site PI) served as the primary recruitment sites for this project. The study will be performed in accordance with the Declaration of Helsinki and satisfy the regulatory requirements in the United States of America. Written informed consent will be obtained from all adult participants included in the study. Written informed assent will be obtained from all participants aged 12–17 years with parents also providing written informed consent prior to participation.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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