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

Stanford University

Status: Enrolling

Conditions: Cancer

Treatments: Behavioral: GOLD Program; Behavioral: Treatment as usual (TAU)

Study type: Interventional

Funder types: Other

Identifiers

NCT05415007

IRB-54525

NCI-2023-00703 (Registry Identifier)

PEDSVAR0063 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion and 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

GOLD Psychosocial Program

Experimental group

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.

Treatment:

Behavioral: GOLD Program

Treatment-as-Usual (TAU)

Active Comparator group

Treatment:

Behavioral: Treatment as usual (TAU)