Caregiver Program for Pediatric Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Developmental disabilities, Cognitive impairment, Severe psychiatric illness, others

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

Compensation: Varies

Number of Visits: 13

33 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment in the Caregiver Program for Pediatric Cancer?

The research highlights the importance of addressing the needs of caregivers for children with cancer, suggesting that structured programs can help meet these needs and improve care. Additionally, involving community physicians in treatment plans has been shown to reduce stress and improve outcomes for both patients and caregivers. ^{1 2 3 4 5}

Is the Caregiver Program for Pediatric Cancer safe for participants?

The research does not provide specific safety data for the Caregiver Program for Pediatric Cancer, but similar caregiver support interventions have been shown to reduce stress and improve quality of life, suggesting they are generally safe for participants. ^{6 7 8 9 10}

How does the Caregiver Program for Pediatric Cancer differ from other treatments?

The Caregiver Program for Pediatric Cancer is unique because it focuses on supporting caregivers through a 13-week session program, which is different from traditional medical treatments that primarily target the child. This program aims to improve the quality of life for both children with cancer and their caregivers by providing psychological support and reducing the need for frequent hospital visits. ^{2 7 10 11 12}

What is the purpose of this trial?

The purpose of this study is to determine if a culturally relevant caregiver intervention is effective in decreasing stress and improving quality of life in Spanish speaking Latino caregivers of children diagnosed with cancer compared to a control group.

Eligibility Criteria

This trial is for Spanish-speaking Latino caregivers of children with cancer. It aims to help them reduce stress and improve their quality of life.

Inclusion Criteria

Caregiver identifies as Latino

Caregiver of CHOC oncology patient must be able to speak and/or read and write in Spanish

I am a caregiver for a child aged 2-17 with cancer at CHOC.

Exclusion Criteria

Caregiver unable to speak, read, and write in Spanish

I do not have any mental health conditions that would stop me from participating in study sessions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in a 13-week culturally relevant caregiver intervention delivered via Zoom, including sessions on health literacy, caregiver wellness, and culturally competent care.

13 weeks

13 virtual sessions

Post-Intervention Assessment

Participants complete measures immediately after the intervention and participate in focus groups or individual interviews.

1-2 weeks

Follow-up

Participants are monitored for quality of life, perceived stress, and emotional functioning 3 months post intervention.

3 months

Treatment Details

Interventions

• 13-week session program

Trial Overview The study tests a 13-week session program designed specifically for these caregivers, comparing its effectiveness against a control group.

Participant Groups

Group I: Intervention Session (Corazones) Group Experimental Treatment 1 Intervention

Caregivers in this group will be asked to participate in a 13-session program (Corazones) delivered via Zoom. Caregivers will be asked to complete study questionnaires at the beginning of the study (Baseline), after completing the 13 zoom-based sessions (T2) and 3 months after participating in the program (T3). Caregivers will also be asked to participate in an interview with members of the research team to discuss their experiences participating in the program.

Group II: Control Group (standard of care) Active Control 1 Intervention

Caregivers will be asked to complete study questionnaires at the beginning of the study (Baseline), following week 2 of the intervention timeline, after week 12 of the intervention timeline (T2), and 3 months after the intervention groups completes their sessions (T3). Caregivers in this group will be offered the opportunity to participate in sessions after T3 surveys are completed. Attendance will not be compensated.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Children's Hospital of Orange County

Collaborator

Trials

38

Recruited

5,700+

Findings from Research

Children with cancer, particularly those with medulloblastoma and acute lymphocytic leukemia (ALL), have better outcomes when treated at university cancer centers compared to nonuniversity centers, highlighting the importance of treatment protocols and specialized resources.

Involving community physicians in the management of pediatric cancer can enhance care by providing support in chemotherapy, infection management, and emotional support, ultimately improving patient outcomes and reducing the financial and emotional burden on families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The community physician's involvement in clinical trials and home treatment. Shah, NR.[2019]

References

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

The challenge of quality care for family caregivers in pediatric cancer care. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of a discharge-planning program and home visits for meeting the physical care needs of children with cancer. [2021]

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

Stress and psychological adjustment in caregivers of children with cancer. [2022]

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

Validation of a Tool to Assess the Multidimensional Needs of the Parents of Children With Cancer. [2022]

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

The community physician's involvement in clinical trials and home treatment. [2019]

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

Sleep disruption in caregivers of pediatric stem cell recipients. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Pediatric psycho-oncology in Russia: Caregiver mental health and sleep outcomes on the oncology wards. [2021]

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

Effectiveness of a Three-Stage Intervention in Reducing Caregiver Distress During Pediatric Hematopoietic Stem Cell Transplantation: A Randomized Controlled Trial. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Safety and family satisfaction of a home-delivered chemotherapy program for children with cancer. [2021]

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

Home chemotherapy for children with cancer. [2019]

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

Feasibility and preliminary outcomes from a pilot study of a brief psychological intervention for families of children newly diagnosed with cancer. [2022]

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

Childhood cancer: a two-year prospective study of the psychological adjustment of children and parents. [2007]