GOLD: Brief Intervention to Reduce Anxiety and Promote Resilience in Families of Youth With Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GOLD Program, Treatment as usual (TAU).
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: 8 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Brief Intervention to Reduce Anxiety and Promote Resilience in Caregivers of Youth With Cancer
Overview
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
- Behavioral GOLD Program
Participant will receive a 2-hour interventional session - Behavioral Treatment as usual (TAU)
Participant will receive treatment-As-Usual which consist of information about diagnosis routinely-disseminated by personnel and providers.
Primary outcome measures
- Number of caregivers who enroll in the GOLD program [Time frame: 1 month]
Secondary outcome measures (1)
- Acceptability of the GOLD Program for caregivers [Time frame: 1 month]
Eligibility 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 Exclusion Criteria: Children
Inclusion:
- Recent (<12 mo) cancer diagnosis in child
- 8-17 Years old
- Provides assent to participate in the study
Exclusion:
- Cannot read English
- Parent is not enrolled in the study
Anyone who is not a caregiver of children who have been diagnosed with cancer within the past 12 months will be excluded.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Stanford Cancer Institute — San Francisco
Identifiers
NCT: NCT05415007 · IRB-54525 · PEDSVAR0063 · NCI-2023-00703