Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT05415007

Recruiting

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

Interventional

Phase not listed

Stanford Cancer Institute

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.

Show Detailed Description

Treatment Category

Behavioral

Required Mutations

None

Trial Started

2022-09-21

Last Updated by Sponsor

2025-07-15

Estimated Completion

2026-12-31

Eligibility

Inclusion Criteria

* Child (0-17yrs) with recent (<12 mo) cancer diagnosis

* Fluent in English

* Consent to research

* Recent (<12 mo) cancer diagnosis in child

* 8-17 Years old

* Provides assent to participate in the study

Exclusion Criteria

* Lack of proficiency in written and spoken English

* Parent is under age 18

* Active Suicidal Ideation

* Child with cancer does not provide assent

* 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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Design Details

AllocationRandomized

Intervention ModelParallel Assignment

MaskingNone (Open Label)

Number to Enroll40

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: 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.

Interventions:

GOLD Program
Treatment as usual (TAU)

Outcome Measures

Primary Outcome Measures

Number of caregivers who enroll in the GOLD program1 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 caregivers1 month

Acceptability will be measure by the percentage of caregivers who provide complete data, and who are retained through 1-month follow-up