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NCT Number: NCT05415007

GOLD: Brief Intervention to Reduce Anxiety and Promote Resilience in Families 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.

Recruiting

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Key information

Conditions

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Cancer Institute

San Francisco, California, 94305, United States

Location status: Recruiting

Location contact

Sheri Spunt, MD

SUB_INVESTIGATOR

Victoria E. Cosgrove, PhD

CONTACT

[email protected]

650-995-6848

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GOLD Program

Behavioral

Participant will receive a 2-hour interventional session

Treatment as Usual (TAU)

Behavioral

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

Primary outcomes

  1. Number of caregivers who enroll in the GOLD program

    Time frame: 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 outcomes

  1. Acceptability of the GOLD Program for caregivers

    Time frame: 1 month

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

Study contacts

Contact information is provided by the study sponsor or research team.

Victoria E. Cosgrove, PhD

CONTACT

[email protected]

650-995-6848

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jun 10, 2022
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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