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

NCT ID: NCT05415007

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-21
• Study Completion Date: 2027-06-30

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

GOLD Psychosocial 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.

Group Type: EXPERIMENTAL

GOLD Program

Intervention Type: BEHAVIORAL

Participant will receive a 2-hour interventional session

Treatment-as-Usual (TAU)

Group Type: ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type: BEHAVIORAL

Participant will receive treatment-As-Usual which consist of information about diagnosis routinely-disseminated by personnel and providers.

Interventions

GOLD Program

Participant will receive a 2-hour interventional session

Intervention Type: BEHAVIORAL

Treatment as usual (TAU)

Participant will receive treatment-As-Usual which consist of information about diagnosis routinely-disseminated by personnel and providers.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

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:

• 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victoria E. Cosgrove, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Cancer Institute

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Victoria E. Cosgrove, PhD

Role: CONTACT

veileen@stanford.edu

650-995-6848

Facility Contacts

Victoria E. Cosgrove, PhD

Role: primary

veileen@stanford.edu

650-995-6848

Other Identifiers

PEDSVAR0063

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2023-00703

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB-54525

Identifier Type: -

Identifier Source: org_study_id