GOLD: Brief Intervention to Reduce Anxiety and Promote Resilience in Families of Youth With Cancer
Purpose
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.
Condition
- Cancer
Eligibility
- Eligible Ages
- Between 8 Years and 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
Active Comparator Treatment-as-Usual (TAU) |
|
Recruiting Locations
San Francisco 5391959, California 5332921 94305
More Details
- NCT ID
- NCT05415007
- Status
- Recruiting
- Sponsor
- Stanford University
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.