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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the GOLD Program treatment for families of youth with cancer?

Research shows that resilience-promoting programs for families of children with cancer can improve coping skills, reduce anxiety, and enhance family adaptation. These programs often include providing information and emotional coping strategies, which have been linked to better mental health outcomes for both children and their families. ^{1 2 3 4 5}

Is the GOLD Program for Childhood Cancer Family Support safe for participants?

The research on resilience-promoting programs for families of children with cancer suggests these programs are generally safe, focusing on providing information and emotional coping strategies to improve mental health outcomes like resilience and reduced anxiety. ^{3 6 7 8 9}

How is the GOLD Program treatment different from other treatments for families of children with cancer?

The GOLD Program is unique because it focuses on reducing anxiety and promoting resilience in families of children with cancer through a brief intervention that includes providing information and emotional coping strategies. Unlike other treatments that may focus solely on the child or medical aspects, this program aims to improve the overall family dynamic and emotional well-being. ^{3 6 10 11 12}

Research Team

Victoria E. Cosgrove, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Utilization of Psychotherapeutic Interventions by Pediatric Psychosocial Providers. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Resilience-Promoting Programs in Families of Children With Cancer: A Systematic Review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Review of family-based psychosocial interventions for childhood cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Treating persistent distress and anxiety in parents of children with cancer: an initial feasibility trial. [2018]

6. England 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. [2023]

7. Iran pubmed.ncbi.nlm.nih.gov

Impact of Ego-resilience and Family Function on Quality of Life in Childhood Leukemia Survivors. [2019]

8. England 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. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

The family bereavement program: efficacy evaluation of a theory-based prevention program for parentally bereaved children and adolescents. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Parents' experiences of a Family Support Program when a parent has incurable cancer. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Psychological treatment for family members of children with cancer: A systematic review and meta-analysis. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Helping the parents of children with malignancy. [2019]