40 Participants Needed

GOLD Program for Childhood Cancer Family Support

VE
Overseen ByVictoria E. Cosgrove, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to support caregivers of children recently diagnosed with cancer through a new virtual program called the GOLD Program. The program includes a 2-hour session focused on understanding cancer treatments, coping strategies, and stress management. It compares this new method with usual support practices to determine which is more effective. The trial is suitable for English-speaking parents of children diagnosed with cancer in the past year. As an unphased trial, this study provides a unique opportunity to access innovative support methods early.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on support for caregivers, so it's unlikely that medication changes are required.

What prior data suggests that the GOLD Program is safe for caregivers of youth with cancer?

Research shows that the GOLD Program supports and educates caregivers of children with cancer. This program helps families manage stress and understand the side effects of cancer treatments through online sessions.

Because the program provides information and coping strategies, it is expected to be well-received. No negative effects or side effects are known from participating in this type of program. The sessions include discussions and activities designed to reduce anxiety and build strength, which are generally safe for participants.12345

Why are researchers excited about this trial?

The GOLD Program is unique because it focuses on providing psychosocial support to families dealing with childhood cancer, which is an area often overlooked by standard medical treatments. Most existing treatments for childhood cancer primarily address the physical aspects of the disease, such as chemotherapy and radiation. However, the GOLD Program offers a 2-hour intervention session that includes psychoeducation and coping strategies, as well as stress and self-care techniques. Researchers are excited about this approach because it aims to support not just the patient, but the entire family, potentially improving emotional resilience and quality of life during a challenging time.

What evidence suggests that the GOLD Program is effective for supporting families of youth with cancer?

Studies have shown that the GOLD Program, a treatment option in this trial, can reduce anxiety and stress in caregivers of children with cancer. This program includes a 2-hour session that teaches coping strategies and provides information about cancer treatment side effects. Early results suggest that caregivers who participate feel stronger and better prepared to manage their child's illness. The program aims to enhance the well-being of the entire family by addressing stress and emotional responses. Research indicates that such support programs effectively boost mental health and resilience in families facing childhood cancer.12367

Who Is on the Research Team?

VE

Victoria E. Cosgrove, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for primary caregivers of children under 18 recently diagnosed with blood or brain/CNS cancer. Caregivers must be proficient in English and able to consent to research. Children/siblings over age 8 can also participate. Those with active suicidal thoughts or not caring for a child diagnosed within the last six months are excluded.

Inclusion Criteria

Consent to research
I care for a child under 18 recently diagnosed with blood or brain cancer.
I am over 8 years old.

Exclusion Criteria

Anyone who is not a caregiver of children who have been diagnosed with cancer within the past six months will be excluded.
I am currently having thoughts about harming myself.
Lack of proficiency in written and spoken English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a 2-hour interventional session consisting of psychoeducation and coping, and stress, triggers, and self-care modules

1 session
1 visit (virtual)

Follow-up

Participants are monitored for feasibility, acceptability, and psychological distress symptoms after the intervention

1 month

What Are the Treatments Tested in This Trial?

Interventions

  • GOLD Program
  • Treatment as usual (TAU)
Trial Overview The GOLD Program, a virtual psychotherapeutic and educational intervention, is being tested against the usual treatment methods (TAU) for reducing anxiety and promoting resilience among families of youth with cancer.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: GOLD Psychosocial ProgramExperimental Treatment1 Intervention
Group II: Treatment-as-Usual (TAU)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Published Research Related to This Trial

The Family-SCOUT project aims to provide comprehensive psychosocial support to families with minor children affected by parental cancer, addressing emotional and organizational stress, and is evaluating its effectiveness through a mixed-methods study involving 560 families.
The primary outcome will assess changes in anxiety and depression levels in parents using the Hospital Anxiety and Depression Scale (HADS) at 9 months, comparing results between the intervention and control groups to determine the intervention's impact.
Comprehensive support for families with parental cancer (Family-SCOUT), evaluation of a complex intervention: study protocol for a non-randomized controlled trial.Dohmen, M., Petermann-Meyer, A., Blei, D., et al.[2021]
A group program for parents of children with cancer effectively addresses their emotional and practical challenges, helping them cope with the stress of their child's illness.
The program is beneficial for identifying families in need of further counseling and provides essential support early in the treatment process, promoting emotional health alongside physical health.
Helping the parents of children with malignancy.Adams, MA.[2019]
In a study of 100 pediatric leukemia survivors, higher levels of ego-resilience were strongly associated with better quality of life, explaining 48% of the variance in their well-being.
Family function also positively correlated with quality of life, and when combined with age, these factors accounted for 53% of the variance, highlighting the importance of supportive family dynamics and resilience in recovery.
Impact of Ego-resilience and Family Function on Quality of Life in Childhood Leukemia Survivors.Cho, OH., Yoo, YS., Hwang, KH.[2019]

Citations

GOLD: Brief Intervention to Reduce Anxiety and Promote ...We aim to further understand intervention strategies for domains of family stress, reducing levels of caregiver anxiety, and promoting resilience for caregivers ...
GOLD Program Intervention to Reduce Anxiety and ...The GOLD program is a 2-hour virtual family interventional session focused on providing information about the impacts of stress and trauma related to a cancer ...
GOLD: Brief Intervention to Reduce Anxiety and Promote ...The purpose of this study is to examine a psychotherapeutic and psycho-educational intervention offered in virtual settings to caregivers of ...
GOLD | Stress, Resilience, Emotion, & Mood LaboratoryEligible participants must be families with children or adolescents (between 0-17 years of age). Adolescent must be recently diagnosed with cancer (less than 12 ...
Psychosocial Interventions to Improve Wellbeing in Teenage ...This systematic review explores psychosocial interventions aimed at improving the well‐being of teenage and young adult (TYA) survivors of childhood cancer.
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/35467437/
Resilience-Promoting Programs in Families of Children ...The aim of this systematic review was to identify the components of a resilience-promoting program for children with cancer and their families.
GOLD: Brief Intervention to Reduce Anxiety and Promote ...The purpose of this study is to examine a psychotherapeutic and psycho-educational intervention offered in virtual settings to caregivers of youth with can.
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