Clinical trial · Interventional
FOCUS:Families OverComing Under Stress
Evaluation of Feasibility and Effect Size of a Resilience Enhancement Program for Couples and Families Contending With Cancer (FOCUS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Depression | — | UNRESOLVED | — |
| PostTraumatic Stress Disorder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOCUS Resilience Enhancement Program | Behavioral | — | UNRESOLVED |
| Waitlist (No Study Treatment) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FOCUS Resilience Enhancement Program
- description
- Those assigned to the immediate treatment group will participate in the 10-week treatment.
- interventionNames
- Behavioral: FOCUS Resilience Enhancement Program
- type
- EXPERIMENTAL
- label
- Waitlist Treatment
- description
- After the 10-week immediate treatment period, wait-list control participants will be administered the treatment.
- interventionNames
- Behavioral: Waitlist (No Study Treatment)
Primary outcomes (1)
- measure
- Feasibility of program as defined by dropout rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available