African American Families Fighting Parental Cancer Together

November 19, 2024 updated by: Adam Davey, University of Delaware
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Baseline to 8 weeks (end of treatment)
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)
Time Frame: Baseline to 8 weeks (end of treatment)
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)
Time Frame: Baseline to 12 months
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)
Time Frame: Baseline to 12 months
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)
Time Frame: Baseline to 12 months
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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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