Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anxiety
  • Depressive Symptoms
  • Parental Stress
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Group (cluster) randomized trial.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.Primary Purpose: Treatment

Participation Requirements

Age
Between 12 years and 125 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT03567330
Collaborators
  • Helen F. Graham Cancer Center & Research Institute at Christiana Care
  • Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
Principal Investigator: Adam Davey, Ph.D. University of Delaware