CancerNCT02992405
FOCUS:Families OverComing Under Stress
A study testing FOCUS Resilience Enhancement Program and Waitlist (No Study Treatment) in people with Cancer and Depression, run by Cedars-Sinai Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Depression, PostTraumatic Stress Disorder
- What is being tested?
- FOCUS Resilience Enhancement Program and Waitlist (No Study Treatment)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2016to 18 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Evaluation of Feasibility and Effect Size of a Resilience Enhancement Program for Couples and Families Contending With Cancer (FOCUS)
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.
Read the 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
- Being tested
- FOCUS Resilience Enhancement Program, Waitlist (No Study Treatment)
- Medical subject headings
- Neoplasms, Depression, Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOCUS Resilience Enhancement ProgramBehavioural
Also called Therapy
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)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| FOCUS Resilience Enhancement Program | Experimental | Those assigned to the immediate treatment group will participate in the 10-week treatment. Receives: Behavioral: FOCUS Resilience Enhancement Program |
| Waitlist Treatment | Experimental | After the 10-week immediate treatment period, wait-list control participants will be administered the treatment. Receives: Behavioral: Waitlist (No Study Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 10 weeks
Secondary outcomes (10)
Change in score of depression as measured by the Patient Health Questionnaire 9 (PHQ-9).
Measured: 10 weeks
Change in score of anxiety as measured by the General Anxiety Disorder 7 (GAD-7).
Measured: 10 weeks
Change in score of post traumatic stress as measured by the PTSD Checklist - Civilian (PCL-C).
Measured: 10 weeks
Change in score of stress in Human Functioning as measured by the Sense of Coherency (SOC).
Measured: 10 weeks
Change in score of quality of life as measured by the Functional Assessment of Cancer Therapy - General Version (FACT-G).
Measured: 10 weeks
Change in score of caregiver's quality of life as measured by the Caregiver Quality of Life Index - Cancer (CQOLC).
Measured: 10 weeks
Change in score of family functioning as measured by the McMasters Family Assessment Device (FAD).
Measured: 10 weeks
Change in score of couples relational functioning as measured by the Revised Dyadic Adjustment Scale (RDAS).
Measured: 10 weeks
Change in parents' score of child functioning as measured by the Strengths and Difficulties Questionnaire (SDQ).
Measured: 10 weeks
Change in patient satisfaction score as measured by the FOCUS Impact Rating Scale (FIRS).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start5 Dec 2016
- Primary completion18 May 2018
- Study completion18 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Saltzman, Cedars-Sinai Medical Center
- Investigators
- William Saltzman, PhD, Principal investigator, Cedars-Sinal Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992405
- Sponsor's protocol ID
- IIT2016-02-SALTZMAN-FOCUS
- Status last verified
- Feb 2019
- First submitted
- 12 Dec 2016
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Feasibility and Effect Size of a Resilience Enhancement Program for Couples and Families Contending With Cancer (FOCUS)
- ClinicalTrials.gov ID
- NCT02992405
- Acronym / sponsor ID
- IIT2016-02-SALTZMAN-FOCUS
- Conditions
- Cancer, Depression, PostTraumatic Stress Disorder, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 18 May 2018 (actual)
- Study completion
- 18 May 2018 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOCUS Resilience Enhancement Program | Experimental | Behavioral: FOCUS Resilience Enhancement ProgramThose assigned to the immediate treatment group will participate in the 10-week treatment. |
| Waitlist Treatment | Experimental | Behavioral: Waitlist (No Study Treatment)After the 10-week immediate treatment period, wait-list control participants will be administered the treatment. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOCUS Resilience Enhancement ProgramAlso: TherapyEach 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). | Behavioural | FOCUS Resilience Enhancement Program |
| 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). | Behavioural | Waitlist Treatment |
Primary outcome
Feasibility of program as defined by dropout rate
Time frame: 10 weeks
A randomized controlled trial will be considered feasible if the dropout rate is less than or equal to 20%.
10 secondary outcomes
Change in score of depression as measured by the Patient Health Questionnaire 9 (PHQ-9).
Time frame: 10 weeks
Change in score of anxiety as measured by the General Anxiety Disorder 7 (GAD-7).
Time frame: 10 weeks
Change in score of post traumatic stress as measured by the PTSD Checklist - Civilian (PCL-C).
Time frame: 10 weeks
Change in score of stress in Human Functioning as measured by the Sense of Coherency (SOC).
Time frame: 10 weeks
Change in score of quality of life as measured by the Functional Assessment of Cancer Therapy - General Version (FACT-G).
Time frame: 10 weeks
Change in score of caregiver's quality of life as measured by the Caregiver Quality of Life Index - Cancer (CQOLC).
Time frame: 10 weeks
Change in score of family functioning as measured by the McMasters Family Assessment Device (FAD).
Time frame: 10 weeks
Change in score of couples relational functioning as measured by the Revised Dyadic Adjustment Scale (RDAS).
Time frame: 10 weeks
Change in parents' score of child functioning as measured by the Strengths and Difficulties Questionnaire (SDQ).
Time frame: 10 weeks
Change in patient satisfaction score as measured by the FOCUS Impact Rating Scale (FIRS).
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Saltzman, PhD principal investigator
Cedars-Sinal Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOCUS Resilience Enhancement Program and Waitlist (No Study Treatment) in people with Cancer and Depression, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of program as defined by dropout rate (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.