African American Families Fighting Parental Cancer Together

African American Families Fighting Parental Cancer Together

Sponsors

Lead Sponsor: University of Delaware

Collaborator: Helen F. Graham Cancer Center & Research Institute at Christiana Care
Sidney Kimmel Cancer Center at Thomas Jefferson University

Source University of Delaware
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 10-week prevention program to help African American parents and caregivers (e.g., grandparents) diagnosed for the first time with Stages I, II, or III solid tumor cancer in the last 12 months who are caring for a 12-18 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.

Overall Status Recruiting
Start Date October 2, 2018
Completion Date June 30, 2022
Primary Completion Date June 30, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Reduce 8-week depressive symptoms among African American adolescents on the Child Depression Inventory (CDI-2) Baseline to 8 weeks (end of treatment)
Secondary Outcome
Measure Time Frame
Reduce 8-week parental stress among African American parents on the Parenting Concerns Questionnaire (PCQ) Baseline to 8 weeks (end of treatment)
Enrollment 172
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Family-based attachment-focused intervention

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

Arm Group Label: Experimental

Intervention Type: Behavioral

Intervention Name: Psychoeducation

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

Arm Group Label: Psychoeducation

Eligibility

Criteria:

Inclusion Criteria:

- Parents must identify as non-Hispanic Black

- Must be diagnosed for the first time with stage I, II, or III solid tumor cancer (e.g., breast, prostate, colorectal, lung) in the last 12 months

- Must be parent or primary caregiver of at least 1 adolescent living (target child) at home (ages 12-18) 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.

Gender: All

Minimum Age: 12 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Adam Davey, Ph.D. Principal Investigator University of Delaware
Overall Contact

Last Name: Adam Davey, Ph.D.

Phone: 302-831-3856

Email: [email protected]

Location
Facility: Status: Contact:
Helen F Graham Cancer Center & Research Institute at Christiana Care | Newark, Delaware, 19713, United States Recruiting Shannon Virtue, PsyD 302-623-4701 [email protected]
Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia, Pennsylvania, 19107, United States Recruiting Alliric Willis, MD 215-955-5528 [email protected]
Location Countries

United States

Verification Date

October 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Delaware

Investigator Full Name: Adam Davey

Investigator Title: Professor, Behavioral Health and Nutrition

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Experimental

Type: Experimental

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.

Label: Psychoeducation

Type: Active Comparator

Description: Provides equivalent number of American Cancer Society psychoeducational sessions.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Group (cluster) randomized trial.

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking Description: Assessors and analysts will be blinded to treatment condition. Participants and providers cannot be effectively blinded to treatment condition.

Source: ClinicalTrials.gov