African American Families Fighting Parental Cancer Together

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.

Study Overview

• Status: Terminated
• Conditions: Anxiety; Depressive Symptoms; Parental Stress
• Intervention / Treatment: Behavioral: Family-based attachment-focused intervention; Behavioral: Psychoeducation

Detailed Description

The investigators will offer a 8-week prevention program to help African American parents and caregivers (e.g., grandparents) diagnosed for the first time with Stages 0, I, II, or III solid tumor cancer or hematologic cancer in the last 24 months who are caring for a 11-21 year old child at home who has been told about the parent's cancer diagnosis. Parents and their adolescent child(ren) will first be asked to complete a set of questionnaires that takes about 60 minutes and then will be told within 2 to 4 weeks whether they have been assigned to 1 of 2 programs that will get chosen by chance, like flipping a coin. Neither the families nor the researchers will choose what program is assigned. Both programs are designed to offer help coping with cancer. Both short- and long-term effects of the program will be evaluated.

Program A involves just parents attending five educational sessions every other week (1 hour/session) with a group of parents who are also coping with cancer with specially trained group leaders. Adolescent children will not participate in these group sessions; this is the treatment as usual comparison group as most cancer centers do not meet with adolescent children who have parents diagnosed with cancer.

Program B involves five group sessions (2 hours/session) every other week with other families like them that include adolescents in some of the sessions and parents and adolescents together in other sessions with specially trained group leaders.

The primary, secondary, and exploratory aims of this research are:

Primary Aim:

Aim 1. Compare the efficacy of Families Fighting Cancer Together (FFCT) to Treatment-as-Usual (TAU) in reducing depressive symptoms (CDI) in AA adolescents at post-treatment using an intention-to-treat (ITT) analysis.

Secondary Aim:

Aim 2. Compare the efficacy of Families Fighting Cancer Together (FFCT) to Treatment-as-Usual (TAU) in reducing parental stress (PCQ) in AA parents at post-treatment using ITT analysis.

Exploratory Aims:

Aim 3a. Determine trajectories of adolescent depressive symptoms (CDI), anxiety (RCMAS), and parental stress (PCQ) from baseline to 12-month follow-up.

Aim 3b. Determine whether perceived levels of group support (HGE), adolescent gender and age, parent's marital and socioeconomic status, and parent's cancer staging modify the effects of treatment on adolescent depression (CDI) and anxiety (RCMAS).

Aim 3c. Determine whether pre-post changes in parent-adolescent attachment and communication mediate the association between treatment and adolescent depressive symptoms (CDI) and anxiety (RCMAS) at 6- and 12-month follow-ups.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • Helen F Graham Cancer Center & Research Institute at Christiana Care
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 5 2-hour biweekly sessions involving parent and/or adolescent(s).
Active Comparator: Psychoeducation; Provides equivalent number of American Cancer Society psychoeducational sessions.	Behavioral: Psychoeducation; Provides equivalent number of American Cancer Society psychoeducational sessions involving only parents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduce 8-week parental stress among African American parents on the Parenting Concerns Questionnaire (PCQ)	Compare the efficacy of Families Fighting Cancer Together (FFCT) to Psychoeducation (PED) in reducing parenting stress on the Parenting Concerns Questionnaire (PCQ) in AA parents at post-treatment using ITT analysis.	Baseline to 8 weeks (end of treatment)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduce 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 (CDI-2) symptoms in AA adolescents at 12 months using an intention-to-treat (ITT) analysis.	Baseline to 12 months
Reduce depressive symptoms among African American adolescents on the Revised Children's Manifest Anxiety Scale (RCMAS-2)	Compare the efficacy of Families Fighting Cancer Together (FFCT) to Psychoeducation (PED) in reducing anxiety on the Revised Children's Manifest Anxiety Scale (RCMAS-2) in AA adolescents at 12 months using an intention-to-treat (ITT) analysis.	Baseline to 12 months
Reduce 8-week parental stress among African American parents on the Parenting Concerns Questionnaire (PCQ)	Compare the efficacy of Families Fighting Cancer Together (FFCT) to Psychoeducation (PED) in reducing parental stress on the Parenting Concerns Questionnaire (PCQ) in AA parents at 12 months using ITT analysis.	Baseline to 12 months

Collaborators and Investigators

• Sponsor: University of Delaware
• Collaborators: Sidney Kimmel Cancer Center at Thomas Jefferson University; Helen F. Graham Cancer Center & Research Institute at Christiana Care
• Investigators: Principal Investigator: Adam Davey, Ph.D., University of Delaware

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2018
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 1165185-1

Plan for Individual participant data (IPD)

Study Data/Documents

1. Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No