GOLD: Brief Intervention to Reduce Anxiety and Promote Resilience in Families of Youth With Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GOLD Psychosocial Program Participant will receive a 2-hour interventional session. Its content will consist of two modules: (1) psychoeducation and coping, providing information in content areas such as side effects of cancer treatments, fever protocols, role disruption and (2) stress, triggers, and self care, where caregivers will be briefed on symptoms of and reactions to traumatic stress in order to help parents accurately label thoughts and emotions related to their child's cancer diagnosis. |
Behavioral: GOLD Program
Participant will receive a 2-hour interventional session
|
| Active Comparator: Treatment-as-Usual (TAU)
|
Behavioral: Treatment as usual (TAU)
Participant will receive treatment-As-Usual which consist of information about diagnosis routinely-disseminated by personnel and providers.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Primary caregiver of a youth (under age 18) with a recent diagnosis (less than 6 months) of blood or brain/CNS cancer
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Consent to research
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For children/siblings who wish to participate, over the age of 8
Exclusion Criteria:
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Lack of proficiency in written and spoken English
-
Active suicidal ideation
Anyone who is not a caregiver of children who have been diagnosed with cancer within the past six months will be excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford Cancer Institute | San Francisco | California | United States | 94305 |
Sponsors and Collaborators
- Stanford University
Investigators
- Principal Investigator: Victoria E. Cosgrove, PhD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-54525
- PEDSVAR0063