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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: GOLD Program; Behavioral: Treatment as usual (TAU)

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victoria E. Cosgrove, PhD; Phone Number: 650-995-6848; Email: veileen@stanford.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94305
      • Recruiting
      • Stanford Cancer Institute
      • Contact: Victoria E. Cosgrove, PhD; Phone Number: 650-995-6848; Email: veileen@stanford.edu
      • Sub-Investigator: Sheri Spunt, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Victoria E. Cosgrove, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 12, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Any types of cancer
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Leukemia, Lymphoid
• Other Study ID Numbers: IRB-54525; PEDSVAR0063 (Other Identifier: OnCore); NCI-2023-00703 (Registry Identifier: National Cancer Institute: Clinical Trials Reporting Program)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No