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

NCT05415007 | Recruiting DMC

• 3 other identifiers: IRB-54525PEDSVAR0063NCI-2023-00703
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Any types of cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acceptability of the GOLD Program for caregivers

  1 month

Study Arms (2)

GOLD Psychosocial Program

EXPERIMENTAL

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

Treatment-as-Usual (TAU)

ACTIVE COMPARATOR

Behavioral: Treatment as usual (TAU)

Interventions

GOLD Program BEHAVIORAL

Participant will receive a 2-hour interventional session

GOLD Psychosocial Program

Treatment as usual (TAU) BEHAVIORAL

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

Treatment-as-Usual (TAU)

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• Child (0-17yrs) with recent (\<12 mo) cancer diagnosis
• Fluent in English
• Consent to research
• Lack of proficiency in written and spoken English
• Parent is under age 18
• Active Suicidal Ideation
• Child with cancer does not provide assent
• Recent (\<12 mo) cancer diagnosis in child
• Years old
• Provides assent to participate in the study
• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Cancer Institute

San Francisco, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Therapeutics

Study Officials

• Victoria E. Cosgrove, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria E. Cosgrove, PhD

CONTACT

650-995-6848; veileen@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 10, 2022
• Study Start: September 21, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

US (1)