NCT02992405

FOCUS:Families OverComing Under Stress

Evaluation of Feasibility and Effect Size of a Resilience Enhancement Program for Couples and Families Contending With Cancer (FOCUS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Cancer
• Depression
• PostTraumatic Stress Disorder
• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	FOCUS Resilience Enhancement Program	Each couple or family will have 10 weekly 75 minute sessions comprising the treatment protocol.Questionnaires will be administered at baseline-before the immediate treatment phase (T1) and after the 10-week treatment is completed (T2).
BEHAVIORAL	Waitlist (No Study Treatment)	Participants assigned to the Waitlist (No Treatment) group will receive the study intervention only after the 10 weeks of the immediate treatment phase has been completed. Questionnaires will be administered at baseline-before the immediate treatment phase (T1) and after the immediate treatment phase is completed (T2).

Timeline

• Start date: 2016-12-05
• Primary completion: 2018-05-18
• Completion: 2018-05-18
• First posted: 2016-12-14
• Last updated: 2019-02-07

Locations

1 site across 1 country: United States