FOCUS:Families OverComing Under Stress

NCT02992405 | Completed

• 1 other identifier: IIT2016-02-SALTZMAN-FOCUS
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Depression; PostTraumatic Stress Disorder; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change in score of depression as measured by the Patient Health Questionnaire 9 (PHQ-9).

  10 weeks

• Change in score of anxiety as measured by the General Anxiety Disorder 7 (GAD-7).

  10 weeks

• Change in score of post traumatic stress as measured by the PTSD Checklist - Civilian (PCL-C).

  10 weeks

• Change in score of stress in Human Functioning as measured by the Sense of Coherency (SOC).

  10 weeks

• Change in score of quality of life as measured by the Functional Assessment of Cancer Therapy - General Version (FACT-G).

  10 weeks

Study Arms (2)

FOCUS Resilience Enhancement Program

EXPERIMENTAL

Those assigned to the immediate treatment group will participate in the 10-week treatment.

Behavioral: FOCUS Resilience Enhancement Program

Waitlist Treatment

EXPERIMENTAL

After the 10-week immediate treatment period, wait-list control participants will be administered the treatment.

Behavioral: Waitlist (No Study Treatment)

Interventions

FOCUS Resilience Enhancement Program BEHAVIORAL

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).

Also known as: Therapy

FOCUS Resilience Enhancement Program

Waitlist (No Study Treatment) BEHAVIORAL

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).

Waitlist Treatment

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Neoplasms; Depression; Stress Disorders, Post-Traumatic; Anxiety Disorders

Interventions

Therapeutics; Waiting Lists

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• William Saltzman, PhD

  Cedars-Sinal Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 14, 2016
• Study Start: December 5, 2016
• Primary Completion: May 18, 2018
• Study Completion: May 18, 2018
• Last Updated: February 7, 2019

Record last verified: 2019-02

Locations

US (1)