GOLD Program for Childhood Cancer Family Support

Overseen By Victoria E. Cosgrove, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Non-English speakers, Under 18, Suicidal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

40 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

Who Is on the Research Team?

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?

Group I: GOLD Psychosocial Program Experimental Treatment 1 Intervention

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.

Group II: Treatment-as-Usual (TAU) Active Control 1 Intervention

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Ego-resilience and Family Function on Quality of Life in Childhood Leukemia Survivors. Cho, OH., Yoo, YS., Hwang, KH.[2019]

A survey of 242 psychosocial providers revealed that psychoeducation is the most commonly offered intervention for children with cancer and their families, regardless of the patient's age or treatment stage.

While evidence-based therapies like cognitive behavioral therapy and mindfulness are frequently used, there is a need for more interventions specifically designed for pediatric oncology, and providers identified barriers such as staffing and communication that hinder quality care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of Psychotherapeutic Interventions by Pediatric Psychosocial Providers. Fair, C., Thompson, A., Barnett, M., et al.[2022]

A pilot study involving five parents of children with cancer showed that a brief cognitive-behavioral intervention significantly reduced parental distress, anxiety, and depressive symptoms after their child's diagnosis.

The study indicates that it is feasible to identify parents experiencing prolonged psychological distress and that providing them with targeted support in a pediatric oncology setting can be beneficial for their well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating persistent distress and anxiety in parents of children with cancer: an initial feasibility trial. Warner, CM., Ludwig, K., Sweeney, C., et al.[2018]

A guided, internet-based cognitive behavioral therapy intervention (EJDeR) was developed to support parents of children who completed cancer treatment, and initial results indicate it is acceptable but has lower adherence rates among fathers.

Interviews with 73 parents revealed a variety of concerns, including feelings of loneliness, low mood, and parenting difficulties, which will inform adaptations to EJDeR to better address these issues and improve its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concerns experienced by parents of children treated for cancer: A qualitative study to inform adaptations to an internet-administered, low-intensity cognitive behavioral therapy intervention. Lundgren, J., Thiblin, E., Lutvica, N., et al.[2023]

A systematic review of eight studies identified key components of resilience-promoting programs for children with cancer and their families, including providing information on coping strategies and emotional support.

These programs led to improved resilience and coping skills, as well as reduced symptoms of depression, anxiety, and posttraumatic stress, highlighting their potential to enhance the quality of life for affected families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resilience-Promoting Programs in Families of Children With Cancer: A Systematic Review. Park, M., Choi, EK., Lee, HJ., et al.[2022]

Psychological treatments for family members of children with cancer showed significant positive effects on reducing anxiety and improving problem-solving skills, with effect sizes of 0.339 and 0.385, respectively, based on a meta-analysis of 40 studies.

Longer-duration, lower-intensity interventions were most effective, particularly for families with younger children undergoing treatment, although the benefits tended to decrease over time after the intervention ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological treatment for family members of children with cancer: A systematic review and meta-analysis. Sánchez-Egea, R., Rubio-Aparicio, M., Sánchez-Meca, J., et al.[2020]

The Family Bereavement Program (FBP) significantly improved parenting skills, coping strategies, and caregiver mental health among 156 families with parentally bereaved children, showing its efficacy as a supportive intervention.

At the 11-month follow-up, the FBP was associated with reduced internalizing and externalizing problems in bereaved children, particularly benefiting girls and those who initially had higher problem scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The family bereavement program: efficacy evaluation of a theory-based prevention program for parentally bereaved children and adolescents. Sandler, IN., Ayers, TS., Wolchik, SA., et al.[2019]

The Family Support Program effectively helped parents with incurable cancer understand their children's needs and reactions, leading to improved family communication and reduced conflicts during a difficult time.

Parents expressed a strong desire for the Family Support Program to be made available to all families facing terminal cancer, highlighting its importance in providing necessary information and coping strategies for both parents and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents' experiences of a Family Support Program when a parent has incurable cancer. Bugge, KE., Helseth, S., Darbyshire, P.[2022]

Psychosocial support for children with cancer is crucial from the moment of diagnosis, with effective adaptation linked to the child's understanding of their situation and the emotional support from their family.

Research has shown that parental distress and available social supports significantly impact a child's adjustment to cancer treatment, highlighting the need for comprehensive support programs for both children and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial issues during the acute treatment of pediatric cancer. Koocher, GP.[2019]

A systematic review of 21 studies on family-based psychosocial interventions for childhood cancer shows that these interventions can be feasible and acceptable, with evidence of beneficial outcomes for families involved.

While only a few interventions were classified as empirically validated treatments, the majority demonstrated positive effects, highlighting the potential effectiveness of involving multiple family members in support strategies for pediatric oncology patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of family-based psychosocial interventions for childhood cancer. Meyler, E., Guerin, S., Kiernan, G., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05415007

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 ...

2.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-00703

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 ...

3.

trialstoday.org

trialstoday.org/list/print/NCT05415007

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 ...

4.

med.stanford.edu

med.stanford.edu/streamlab/research/GOLD.html

GOLD | Stress, Resilience, Emotion, & Mood Laboratory

Eligible participants must be families with children or adolescents (between 0-17 years of age). Adolescent must be recently diagnosed with cancer (less than 12 ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11806280/

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.gov

pubmed.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.

7.

ancora.ai

ancora.ai/fr/details/NCT05415007

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.