African American Families Fighting Parental Cancer Together

NCT03567330 | Terminated

• 1 other identifier: 1165185-1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to test the usefulness of a family-based program for African American parents/primary caregivers with newly diagnosed solid tumor cancer and their adolescent children. The program is designed to promote family communication reduce and depressive symptoms for adolescence.

Conditions

Depressive Symptoms; Anxiety; Parental Stress

Outcome Measures

Primary Outcomes (1)

• Reduce 8-week depressive symptoms among African American adolescents on the Child Depression Inventory (CDI-2)

  Compare the efficacy of Families Fighting Cancer Together (FFCT) to Psychoeducation (PED) in reducing Child Depression Inventory symptoms (CDI-2) in AA adolescents at post-treatment using an intention-to-treat (ITT) analysis.

  Baseline to 8 weeks (end of treatment)

Secondary Outcomes (1)

• Reduce 8-week parental stress among African American parents on the Parenting Concerns Questionnaire (PCQ)

  Baseline to 8 weeks (end of treatment)

Other Outcomes (3)

• Reduce depressive symptoms among African American adolescents on the Child Depression Inventory (CDI-2)

  Baseline to 12 months

• Reduce depressive symptoms among African American adolescents on the Revised Children's Manifest Anxiety Scale (RCMAS-2)

  Baseline to 12 months

• Reduce 8-week parental stress among African American parents on the Parenting Concerns Questionnaire (PCQ)

  Baseline to 12 months

Study Arms (2)

Experimental

EXPERIMENTAL

Family-based attachment-focused intervention for families where parent/caregiver is within 12 months of first diagnosis of a stage I-III solid tumor cancer.

Behavioral: Family-based attachment-focused intervention

Psychoeducation

ACTIVE COMPARATOR

Provides equivalent number of American Cancer Society psychoeducational sessions.

Behavioral: Psychoeducation

Interventions

Family-based attachment-focused intervention BEHAVIORAL

5 2-hour biweekly sessions involving parent and/or adolescent(s).

Experimental

Psychoeducation BEHAVIORAL

Provides equivalent number of American Cancer Society psychoeducational sessions involving only parents.

Psychoeducation

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents must identify as non-Hispanic Black
• Must be diagnosed for the first time with stage 0, I, II, or III solid tumor cancer (e.g., breast, prostate, colorectal, lung) or hematologic cancer in the last 24 months
• Must be parent or primary caregiver of at least 1 adolescent living (target child) at home (ages 11-21) who has been told about the diagnosis

You may not qualify if:

• Parents with serious mental health illness that prevents them from participating in the group sessions (e.g., clinically relevant depressive symptomatology as evidenced by the Center for Epidemiological Studies Depression Scale \>27)
• Parents with psychotic features or severe cognitive impairment
• Parents not fluent in English.
• Severely depressed adolescents (CDI-2; T-scores of 70 and higher on the total 28-item CDI-2 scale
• Severely anxious adolescents (RCMAS-2; We will use a cutoff score of 71 (T-score) or higher to screen out African American adolescents with severe anxiety) at baseline
• Adolescents with psychotic features
• Adolescents with cognitive impairment (e.g., mental retardation, severe developmental disorders) as evidenced by educational records, parental report and/or clinical impression
• Adolescents currently in active outpatient mental health treatment.

Sponsors & Collaborators

• University of Delaware: lead
• Helen F. Graham Cancer Center & Research Institute at Christiana Care: collaborator
• Sidney Kimmel Cancer Center at Thomas Jefferson University: collaborator

Study Sites (2)

Helen F Graham Cancer Center & Research Institute at Christiana Care

Newark, Delaware, 19713, United States

Location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• McKinney NS, Virtue S, Lewis FM, Willis AI, Pettyjohn T, Harmon LR, Davey A. Study protocol: a randomized control trial of African American families fighting parental cancer together. BMC Cancer. 2018 Nov 20;18(1):1140. doi: 10.1186/s12885-018-5052-8.

  PMID: 30453906 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Adam Davey, Ph.D.

  University of Delaware

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors and analysts will be blinded to treatment condition. Participants and providers cannot be effectively blinded to treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Behavioral Health and Nutrition

Model Details: Group (cluster) randomized trial. Total number of participants is 200, including 100 men and 100 women.

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 25, 2018
• Study Start: October 2, 2018
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

US (2)