FOCUS:Families OverComing Under Stress

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.

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:

1. 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.

2. Couples or parents must be at least 18 years old and must be English speakers.

3. 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.

4. The families participating in the study must have at least one child older than the
age of five.

5. Participating families must have at least one parent who can provide legal consent for
the participation of their child(ren) in the program.

6. Participants must be willing and able to complete 10 sessions within 14 weeks.

7. Participants undergoing active management or care plans for abuse or psychopathology
may enroll in study if reports of ongoing management are provided.

Exclusion Criteria:

1. 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).

2. 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.

3. Primary presenting personal and/or relational issues are largely unrelated to the
cancer diagnosis and treatment, as determined by the screening clinician.