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| ID | Type | Description | Link |
|---|---|---|---|
| PEDSVAR0063 | Other Identifier | OnCore | |
| NCI-2023-00703 | Registry Identifier | National Cancer Institute: Clinical Trials Reporting Program |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GOLD Psychosocial Program | Experimental | 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. |
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| Treatment-as-Usual (TAU) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GOLD Program | Behavioral | Participant will receive a 2-hour interventional session |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of caregivers who enroll in the GOLD program | Measurement will be based on the percentage of caregivers who provide consent, and are retained in the program through 1-month follow-up. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the GOLD Program for caregivers | Acceptability will be measure by the percentage of caregivers who provide complete data, and who are retained through 1-month follow-up | 1 month |
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Inclusion and Exclusion Criteria: Parents
Inclusion
Exclusion:
Inclusion and Exclusion Criteria: Children
Inclusion:
Exclusion:
Anyone who is not a caregiver of children who have been diagnosed with cancer within the past 12 months will be excluded.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria E. Cosgrove, PhD | Contact | 650-995-6848 | veileen@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Victoria E. Cosgrove, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute | Recruiting | San Francisco | California | 94305 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as usual (TAU) | Behavioral | Participant will receive treatment-As-Usual which consist of information about diagnosis routinely-disseminated by personnel and providers. |
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