FOCUS:Families OverComing Under Stress

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992405
• Other study ID #: IIT2016-02-SALTZMAN-FOCUS
• Status: Completed
• Phase: N/A
• Start date: December 5, 2016
• Est. completion date: May 18, 2018

Study information

• Verified date: February 2019
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 18, 2018
• Est. primary completion date: May 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Cancer
• Depression
• PostTraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of program as defined by dropout rate	A randomized controlled trial will be considered feasible if the dropout rate is less than or equal to 20%.	10 weeks
Secondary	Change in score of depression as measured by the Patient Health Questionnaire 9 (PHQ-9).		10 weeks
Secondary	Change in score of anxiety as measured by the General Anxiety Disorder 7 (GAD-7).		10 weeks
Secondary	Change in score of post traumatic stress as measured by the PTSD Checklist - Civilian (PCL-C).		10 weeks
Secondary	Change in score of stress in Human Functioning as measured by the Sense of Coherency (SOC).		10 weeks
Secondary	Change in score of quality of life as measured by the Functional Assessment of Cancer Therapy - General Version (FACT-G).		10 weeks
Secondary	Change in score of caregiver's quality of life as measured by the Caregiver Quality of Life Index - Cancer (CQOLC).		10 weeks
Secondary	Change in score of family functioning as measured by the McMasters Family Assessment Device (FAD).		10 weeks
Secondary	Change in score of couples relational functioning as measured by the Revised Dyadic Adjustment Scale (RDAS).		10 weeks
Secondary	Change in parents' score of child functioning as measured by the Strengths and Difficulties Questionnaire (SDQ).		10 weeks
Secondary	Change in patient satisfaction score as measured by the FOCUS Impact Rating Scale (FIRS).		10 weeks