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

Not Applicable

Recruiting

• Conditions: Cancer
• Interventions: Behavioral: GOLD Program; Behavioral: Treatment as usual (TAU)

• Registration Number: NCT05415007
• Lead Sponsor: Stanford University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-03-23
• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-10
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GOLD Psychosocial Program	GOLD 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.
Treatment-as-Usual (TAU)	Treatment as usual (TAU)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Stanford Cancer Institute; 🇺🇸 San Francisco, California, United States