FOCUS:Families OverComing Under Stress
Status
Conditions
Treatments
Details and patient eligibility
About
The FOCUS program (study treatment) is an established evidence-based intervention whose redesign for families and couples dealing with serious and chronic illnesses will provide a creative and promising supplement to the existing support services at Cedars-Sinai Medical Center. All participants will receive the 10-weeks of 75-minute weekly study treatment, but will be split into two groups, the immediate treatment group and the wait list treatment group, who will receive the study treatment after the immediate 10 weeks of treatment is completed.
Full description
Despite advances in the development of brief evidence-based programs for families and couples contending with illness, trauma or loss, the support services provided at even top-tier medical facilities are overwhelmingly focused on the individual patient. In most cases, combined treatment with spouses and family members is the exception rather than the rule.
FOCUS is one of the very few programs that has a strong evidence base and has been used in medical settings. It is a preventive, skill-based training program that is customized for each couple or family and is designed to build upon existing strengths in order to enhance family and individual resilience.
A cancer diagnosis is a family affair. Research has shown that the family or spousal relationship can be instrumental in lessening patient distress and supporting treatment compliance and positive adjustment across the various stages of treatment, survivorship, recurrence / relapse, and end-of-life. Reductions in patient depression and anxiety through couple or family interventions may reduce overall healthcare utilization and cost while improving care quality.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Written informed consent will be obtained from each participating adult subject and written assent from each minor participating in the program. Specific criteria for inclusion into the program are as follows:
- Couples must have at least one partner and families at least one parent who is or has been diagnosed with cancer at least 30 days prior to study start and not more than one year from last treatment visit.
- Couples or parents must be at least 18 years old and must be English speakers.
- At least one member of the couple must score >60 on the Anxiety or Depression scale on the Brief Symptom Index 18 administered during the screening visit and/or have notable difficulties in relationship or family functioning, as resulted in a ≥2 score in FAD subscale or at least one RDAS subscale question answered 'more often than not' or more frequent.
- The families participating in the study must have at least one child older than the age of five.
- Participating families must have at least one parent who can provide legal consent for the participation of their child(ren) in the program.
- Participants must be willing and able to complete 10 sessions within 14 weeks.
- Participants undergoing active management or care plans for abuse or psychopathology may enroll in study if reports of ongoing management are provided.
Exclusion criteria
- There must not be any participant with urgent and/or immediate health needs (where a possible 10-week wait time poses more than minimal risks).
- There must not be active (within the last 30 days and/or during study intervention) and unmanaged domestic violence or abuse, substance abuse, or extreme forms of psychopathology such as psychosis that would interfere with the treatment.
- Primary presenting personal and/or relational issues are largely unrelated to the cancer diagnosis and treatment, as determined by the screening clinician.
Trial design
Primary purpose
Allocation
Interventional model
Masking
32 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal