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.
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03567330.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
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.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Delaware
- Primary ID1165185-1
- Secondary IDsNCI-2020-01294
- ClinicalTrials.gov IDNCT03567330