African American Families Fighting Parental Cancer Together

Anxiety Clinical Trial

Official title:

African American Families Fighting Parental Cancer Together

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03567330
• Other study ID #: 1165185-1
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: University of Delaware
• Contact: Adam Davey, Ph.D.
• Phone: 302-831-3856
• Email: davey[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms
• Parental Stress

Intervention

Behavioral:
• Family-based attachment-focused intervention
5 2-hour biweekly sessions involving parent and/or adolescent(s).
• Psychoeducation
Provides equivalent number of American Cancer Society psychoeducational sessions involving only parents.

Locations

Country	Name	City	State
United States	Helen F Graham Cancer Center & Research Institute at Christiana Care	Newark	Delaware
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Delaware	Helen F. Graham Cancer Center & Research Institute at Christiana Care, Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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)

External Links

•   Families Fighting Cancer Together