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FOCUS:Families OverComing Under Stress

Primary Purpose

Cancer, Depression, PostTraumatic Stress Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FOCUS Resilience Enhancement Program

Waitlist (No Study Treatment)

About this trial

This is an interventional supportive care trial for Cancer

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy 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.

Sites / Locations

Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

FOCUS Resilience Enhancement Program

Waitlist Treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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

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

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

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

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

Change in score of caregiver's quality of life as measured by the Caregiver Quality of Life Index - Cancer (CQOLC).

Change in score of family functioning as measured by the McMasters Family Assessment Device (FAD).

Change in score of couples relational functioning as measured by the Revised Dyadic Adjustment Scale (RDAS).

Change in parents' score of child functioning as measured by the Strengths and Difficulties Questionnaire (SDQ).

Change in patient satisfaction score as measured by the FOCUS Impact Rating Scale (FIRS).

Full Information

NCT ID

NCT02992405

First Posted

December 12, 2016

Last Updated

February 5, 2019

Sponsor

Cedars-Sinai Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02992405

Brief Title

FOCUS:Families OverComing Under Stress

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

December 5, 2016 (Actual)

Primary Completion Date

May 18, 2018 (Actual)

Study Completion Date

May 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Depression, PostTraumatic Stress Disorder, Anxiety

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FOCUS Resilience Enhancement Program

Arm Type

Experimental

Arm Description

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

Arm Title

Waitlist Treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

FOCUS Resilience Enhancement Program

Other Intervention Name(s)

Therapy

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Waitlist (No Study Treatment)

Intervention Description

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).

Primary Outcome Measure Information:

Title

Feasibility of program as defined by dropout rate

Description

A randomized controlled trial will be considered feasible if the dropout rate is less than or equal to 20%.

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

10 weeks

Title

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

Time Frame

10 weeks

Title

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

Time Frame

10 weeks

Title

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

Time Frame

10 weeks

Title

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

Time Frame

10 weeks

Title

Change in score of caregiver's quality of life as measured by the Caregiver Quality of Life Index - Cancer (CQOLC).

Time Frame

10 weeks

Title

Change in score of family functioning as measured by the McMasters Family Assessment Device (FAD).

Time Frame

10 weeks

Title

Change in score of couples relational functioning as measured by the Revised Dyadic Adjustment Scale (RDAS).

Time Frame

10 weeks

Title

Change in parents' score of child functioning as measured by the Strengths and Difficulties Questionnaire (SDQ).

Time Frame

10 weeks

Title

Change in patient satisfaction score as measured by the FOCUS Impact Rating Scale (FIRS).

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Saltzman, PhD

Organizational Affiliation

Cedars-Sinal Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

12. IPD Sharing Statement

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