CancerNCT05415007
GOLD: Brief Intervention to Reduce Anxiety and Promote Resilience in Families of Youth With Cancer
A study testing GOLD Program and Treatment as usual (TAU) in people with Cancer, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cancer
- What is being tested?
- GOLD Program and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Child (0-17yrs) with recent (<12 mo) cancer diagnosis
- Fluent in English
- Consent to research
- Recent (<12 mo) cancer diagnosis in child
- 8-17 Years old
- Provides assent to participate in the study
Who cannot join
- Lack of proficiency in written and spoken English
- Parent is under age 18
- Active Suicidal Ideation
- Child with cancer does not provide assent
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Cancer Institute
San Francisco, California, 94305
Victoria E. Cosgrove, PhD, 650-995-6848, veileen@stanford.edu
Sheri Spunt, MD
About this study
Official title: Brief Intervention to Reduce Anxiety and Promote Resilience in Caregivers of Youth With Cancer
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- GOLD Program, Treatment as usual (TAU)
- Keywords
- Any types of cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GOLD ProgramBehavioural
Participant will receive a 2-hour interventional session
Treatment as usual (TAU)Behavioural
Participant will receive treatment-As-Usual which consist of information about diagnosis routinely-disseminated by personnel and providers.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: GOLD Program |
| Treatment-as-Usual (TAU) | Active comparator | Not described Receives: Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start21 Sep 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoria E. Cosgrove, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415007
- Sponsor's protocol ID
- IRB-54525
- Other IDs
- PEDSVAR0063, NCI-2023-00703
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2022
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention to Reduce Anxiety and Promote Resilience in Caregivers of Youth With Cancer
- ClinicalTrials.gov ID
- NCT05415007
- Acronym / sponsor ID
- IRB-54525
- Conditions
- Cancer
- Keywords
- Any types of cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GOLD Psychosocial Program | Experimental | Behavioral: GOLD ProgramParticipant 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. |
| Treatment-as-Usual (TAU) | Active comparator | Behavioral: Treatment as usual (TAU) |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Child (0-17yrs) with recent (<12 mo) cancer diagnosis
- Fluent in English
- Consent to research
- Recent (<12 mo) cancer diagnosis in child
- 8-17 Years old
Key exclusion criteria (7 listed)
- Lack of proficiency in written and spoken English
- Parent is under age 18
- Active Suicidal Ideation
- Child with cancer does not provide assent
- Cannot read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GOLD ProgramParticipant will receive a 2-hour interventional session | Behavioural | GOLD Psychosocial Program |
| Treatment as usual (TAU)Participant will receive treatment-As-Usual which consist of information about diagnosis routinely-disseminated by personnel and providers. | Behavioural | Treatment-as-Usual (TAU) |
Primary outcome
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.
1 secondary outcome
Acceptability of the GOLD Program for caregivers
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victoria E. Cosgrove, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GOLD Program and Treatment as usual (TAU) in people with Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria E. Cosgrove, PhD (650-995-6848, veileen@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of caregivers who enroll in the GOLD program (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.