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Clinical Trials/NCT05415007
NCT05415007
Recruiting
N/A

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

Stanford University1 site in 1 country40 target enrollmentSeptember 21, 2022
ConditionsCancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cancer
Sponsor
Stanford University
Enrollment
40
Locations
1
Primary Endpoint
Number of caregivers who enroll in the GOLD program
Status
Recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 21, 2022
End Date
June 30, 2027
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 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
  • Inclusion and Exclusion Criteria: Children
  • Recent (\<12 mo) cancer diagnosis in child
  • 8-17 Years old

Outcomes

Primary Outcomes

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

  • Acceptability of the GOLD Program for caregivers(1 month)

Study Sites (1)

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