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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOCUS Resilience Enhancement Program | Experimental | Those assigned to the immediate treatment group will participate in the 10-week treatment. |
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| Waitlist Treatment | Experimental | After the 10-week immediate treatment period, wait-list control participants will be administered the treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Saltzman, PhD | Cedars-Sinal Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003863 | Depression |
| D013313 | Stress Disorders, Post-Traumatic |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| 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). |
|
| 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 |
| Change in score of caregiver's quality of life as measured by the Caregiver Quality of Life Index - Cancer (CQOLC). | 10 weeks |
| Change in score of family functioning as measured by the McMasters Family Assessment Device (FAD). | 10 weeks |
| Change in score of couples relational functioning as measured by the Revised Dyadic Adjustment Scale (RDAS). | 10 weeks |
| Change in parents' score of child functioning as measured by the Strengths and Difficulties Questionnaire (SDQ). | 10 weeks |
| Change in patient satisfaction score as measured by the FOCUS Impact Rating Scale (FIRS). | 10 weeks |
| D001523 | Mental Disorders |