Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT02992405
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:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT02992405
Study Brief:
Protocol Section:
NCT02992405