GOLD: Brief Intervention to Reduce Anxiety and Promote Resilience in Families of Youth With Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Brief Intervention to Reduce Anxiety and Promote Resilience in Caregivers of Youth With Cancer

Conditions
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Bone and Joints, Brain and Nervous System, Leukemia, NOS, Lymphoid Leukemia, Myeloid and Monocytic Leukemia

Intervention / Treatment
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* Behavioral: GOLD Program
* Behavioral: Treatment as usual (TAU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary caregiver of a youth (under age 18) with a recent diagnosis (less than 6 months) of blood or brain/CNS cancer Consent to research For children/siblings who wish to participate, over the age of 8 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GOLD Psychosocial Program<br>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<br>* Participant will receive a 2-hour interventional session<br>|
| Active Comparator: Treatment-as-Usual (TAU)<br> | Behavioral: Treatment as usual (TAU)<br>* Participant will receive treatment-As-Usual which consist of information about diagnosis routinely-disseminated by personnel and providers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |