This clinical trial tests how well the GOLD program works in supporting families that have had a child recently diagnosed with cancer. The researchers want to further understand intervention strategies for domains of family stress, reducing levels of caregiver anxiety, and promoting resilience for caregivers, as well as examine the nature and intensity of psychosocial stress in families where a child is in treatment for pediatric cancer. Gaining a better understanding of family stress could help expand the availability of mental health services in pediatric oncology. The GOLD program is a 2-hour virtual family interventional session focused on providing information about the impacts of stress and trauma related to a cancer diagnosis/treatment, guidance regarding family communication, recommendations for available psychosocial resources, and oncology-specific psychoeducation.
Additional locations may be listed on ClinicalTrials.gov for NCT05415007.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo AltoStatus: Active
Contact: Victoria Cosgrove
Phone: 650-995-6848
Lucile Packard Children's Hospital Stanford UniversityStatus: Active
Contact: Victoria Cosgrove
PRIMARY OBJECTIVES:
I. To examine the feasibility of enrolling and retaining caregivers in a study to assess the GOLD program in families with a new pediatric cancer diagnosis.
II. To determine the feasibility of performing the data collection procedures as planned.
III. To determine whether caregivers find the GOLD program to be acceptable.
IV. To determine whether the GOLD program impacts primary outcomes in the context of a modest pilot study.
SECONDARY OBJECTIVES:
I. 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).
II. To further our understanding of family stress and expand the idea for a need of mental health services in pediatric oncology.
III. To further understand intervention strategies for domains of family stress, reducing levels of caregiver anxiety, and promoting resilience for caregivers.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants participate in the GOLD intervention program, and complete surveys on study. Participants have the option to attend a 30-minute virtual follow-up interview.
ARM II: Participants placed on the waitlist for 1-month, and then complete the intervention as in arm I.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorVictoria Cosgrove
