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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05415007
• Other study ID #: IRB-54525
• Secondary ID: PEDSVAR0063
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: March 2024

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Victoria E. Cosgrove, PhD
• Phone: 650-995-6848
• Email: veileen[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• GOLD Program
Participant will receive a 2-hour interventional session
• Treatment as usual (TAU)
Participant will receive treatment-As-Usual which consist of information about diagnosis routinely-disseminated by personnel and providers.

Locations

Country	Name	City	State
United States	Stanford Cancer Institute	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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