Cancer
Conditions
Keywords
Any types of cancer
Brief summary
The purpose of this study is to examine a psychotherapeutic and psycho-educational intervention offered in virtual settings to caregivers of youth with cancer. Human subjects must be used because they are the object of the intervention.
Detailed description
PRIMARY OBJECTIVE(S)- To examine the feasibility and accessibility of a brief intervention for caregivers of youth with newly-diagnosed cancer as a preliminary, data-generating step toward applying for a larger NCI R34 grant evaluating the efficacy of the program in a randomized controlled trial. SECONDARY OBJECTIVE(S)- We hope to learn whether a psycho-educational, psychotherapeutic intervention offered in a virtual setting to caregivers of children diagnosed with cancer is feasible, is acceptable, and can prevent, minimize, or improve symptoms of psychological distress (including symptoms of anxiety, depression, and post-traumatic stress disorder). We also hope to further our understanding of family stress and expand the idea for a need of mental health services in pediatric oncology. We aim to further understand intervention strategies for domains of family stress, reducing levels of caregiver anxiety, and promoting resilience for caregivers. This is important because these symptoms can affect the quality of life of caregivers and affect their ability to adhere to their children's treatments.
Interventions
BEHAVIORALGOLD Program
Participant will receive a 2-hour interventional session
BEHAVIORALTreatment as usual (TAU)
Participant will receive treatment-As-Usual which consist of information about diagnosis routinely-disseminated by personnel and providers.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Inclusion and
Exclusion criteria
Parents Inclusion * Child (0-17yrs) with recent (\<12 mo) cancer diagnosis * Fluent in English * Consent to research Exclusion: * Lack of proficiency in written and spoken English * Parent is under age 18 * Active Suicidal Ideation * Child with cancer does not provide assent Inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of caregivers who enroll in the GOLD program | 1 month | Measurement will be based on the percentage of caregivers who provide consent, and are retained in the program through 1-month follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the GOLD Program for caregivers | 1 month | Acceptability will be measure by the percentage of caregivers who provide complete data, and who are retained through 1-month follow-up |
Countries
United States
Contacts
CONTACTVictoria E. Cosgrove, PhD
PRINCIPAL_INVESTIGATORVictoria E. Cosgrove, PhD
Stanford University
Outcome results
None listed