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

Primary Purpose

Bone and Joints, Brain and Nervous System, Leukemia, NOS

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GOLD Program
Treatment as usual (TAU)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bone and Joints

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary caregiver of a youth (under age 18) with a recent diagnosis (less than 6 months) of blood or brain/CNS cancer
  • Consent to research
  • For children/siblings who wish to participate, over the age of 8

Exclusion Criteria:

  • Lack of proficiency in written and spoken English
  • Active suicidal ideation

Anyone who is not a caregiver of children who have been diagnosed with cancer within the past six months will be excluded.

Sites / Locations

  • Stanford Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GOLD Psychosocial Program

Treatment-as-Usual (TAU)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 8, 2022
Last Updated
July 14, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05415007
Brief Title
GOLD: Brief Intervention to Reduce Anxiety and Promote Resilience in Families of Youth With Cancer
Official Title
Brief Intervention to Reduce Anxiety and Promote Resilience in Caregivers of Youth With Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone and Joints, Brain and Nervous System, Leukemia, NOS, Lymphoid Leukemia, Myeloid and Monocytic Leukemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GOLD Psychosocial Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment-as-Usual (TAU)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
GOLD Program
Intervention Description
Participant will receive a 2-hour interventional session
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
Participant will receive treatment-As-Usual which consist of information about diagnosis routinely-disseminated by personnel and providers.
Primary Outcome Measure Information:
Title
Number of caregivers who enroll in the GOLD program
Description
Measurement will be based on the percentage of caregivers who provide consent, and are retained in the program through 1-month follow-up.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Acceptability of the GOLD Program for caregivers
Description
Acceptability will be measure by the percentage of caregivers who provide complete data, and who are retained through 1-month follow-up
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary caregiver of a youth (under age 18) with a recent diagnosis (less than 6 months) of blood or brain/CNS cancer Consent to research For children/siblings who wish to participate, over the age of 8 Exclusion Criteria: Lack of proficiency in written and spoken English Active suicidal ideation Anyone who is not a caregiver of children who have been diagnosed with cancer within the past six months will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria E. Cosgrove, PhD
Phone
650-995-6848
Email
veileen@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria E. Cosgrove, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Cancer Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria E. Cosgrove, PhD
Phone
650-995-6848
Email
veileen@stanford.edu
First Name & Middle Initial & Last Name & Degree
Sheri Spunt, MD

12. IPD Sharing Statement

Learn more about this trial

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

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