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African American Families Fighting Parental Cancer Together

Primary Purpose

Depressive Symptoms, Anxiety, Parental Stress

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-based attachment-focused intervention
Psychoeducation
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms

Eligibility Criteria

11 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Helen F Graham Cancer Center & Research Institute at Christiana CareRecruiting
  • Sidney Kimmel Cancer Center at Thomas Jefferson UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Psychoeducation

Arm Description

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.

Provides equivalent number of American Cancer Society psychoeducational sessions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 23, 2018
Last Updated
November 8, 2022
Sponsor
University of Delaware
Collaborators
Helen F. Graham Cancer Center & Research Institute at Christiana Care, Sidney Kimmel Cancer Center at Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT03567330
Brief Title
African American Families Fighting Parental Cancer Together
Official Title
African American Families Fighting Parental Cancer Together
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2018 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware
Collaborators
Helen F. Graham Cancer Center & Research Institute at Christiana Care, Sidney Kimmel Cancer Center at Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Anxiety, Parental Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group (cluster) randomized trial. Total number of participants is 200, including 100 men and 100 women.
Masking
Outcomes Assessor
Masking Description
Assessors and analysts will be blinded to treatment condition. Participants and providers cannot be effectively blinded to treatment condition.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Description
Provides equivalent number of American Cancer Society psychoeducational sessions.
Intervention Type
Behavioral
Intervention Name(s)
Family-based attachment-focused intervention
Intervention Description
5 2-hour biweekly sessions involving parent and/or adolescent(s).
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
Provides equivalent number of American Cancer Society psychoeducational sessions involving only parents.
Primary Outcome Measure Information:
Title
Reduce 8-week depressive symptoms among African American adolescents on the Child Depression Inventory (CDI-2)
Description
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.
Time Frame
Baseline to 8 weeks (end of treatment)
Secondary Outcome Measure Information:
Title
Reduce 8-week parental stress among African American parents on the Parenting Concerns Questionnaire (PCQ)
Description
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.
Time Frame
Baseline to 8 weeks (end of treatment)
Other Pre-specified Outcome Measures:
Title
Reduce depressive symptoms among African American adolescents on the Child Depression Inventory (CDI-2)
Description
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.
Time Frame
Baseline to 12 months
Title
Reduce depressive symptoms among African American adolescents on the Revised Children's Manifest Anxiety Scale (RCMAS-2)
Description
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.
Time Frame
Baseline to 12 months
Title
Reduce 8-week parental stress among African American parents on the Parenting Concerns Questionnaire (PCQ)
Description
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.
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Davey, Ph.D.
Phone
302-831-3856
Email
davey@udel.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole S McKinney, Ph.D.
Phone
302-831-8673
Email
nsmckinn@udel.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Davey, Ph.D.
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helen F Graham Cancer Center & Research Institute at Christiana Care
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Virtue, PsyD
Phone
302-623-4701
Email
shannon.virtue@christianacare.org
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alliric Willis, MD
Phone
215-955-5528
Email
alliric.willis@jefferson.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
26048632
Citation
Davey MP, Bilkins B, Diamond G, Willis AI, Mitchell EP, Davey A, Young FM. African American Patients' Psychosocial Support Needs and Barriers to Treatment: Patient Needs Assessment. J Cancer Educ. 2016 Sep;31(3):481-7. doi: 10.1007/s13187-015-0861-9.
Results Reference
background
PubMed Identifier
22949136
Citation
Davey MP, Kissil K, Lynch L, Harmon LR, Hodgson N. A culturally adapted family intervention for African American families coping with parental cancer: outcomes of a pilot study. Psychooncology. 2013 Jul;22(7):1572-80. doi: 10.1002/pon.3172. Epub 2012 Sep 5.
Results Reference
background
PubMed Identifier
22791545
Citation
Davey MP, Kissil K, Lynch L, Harmon LR, Hodgson N. Lessons learned in developing a culturally adapted intervention for African-American families coping with parental cancer. J Cancer Educ. 2012 Dec;27(4):744-51. doi: 10.1007/s13187-012-0398-0.
Results Reference
background
PubMed Identifier
20198717
Citation
Davey MP, Tubbs CY, Kissil K, Nino A. 'We are survivors too': African-American youths' experiences of coping with parental breast cancer. Psychooncology. 2011 Jan;20(1):77-87. doi: 10.1002/pon.1712.
Results Reference
background
PubMed Identifier
30453906
Citation
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.
Results Reference
derived
Links:
URL
http://sites.udel.edu/ffc-together
Description
Families Fighting Cancer Together

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African American Families Fighting Parental Cancer Together

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