Caregiver Program for Pediatric Cancer

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special program can reduce stress and improve the quality of life for Spanish-speaking Latino caregivers of children diagnosed with cancer. Participants will either join a 13-week session program conducted via Zoom or receive the usual support care. This trial is ideal for caregivers of children who are oncology patients at the Children's Hospital of Orange County, have received a diagnosis within the last year, and can speak, read, or write in Spanish. As an unphased trial, it offers caregivers a unique opportunity to access potentially beneficial support programs tailored to their needs.

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 prior data suggests that this caregiver program is safe for participants?

Research shows that the 13-week program for caregivers has manageable side effects. It aims to help caregivers of children with cancer by reducing stress and improving their quality of life. Participants generally receive the program well, experiencing no major negative effects. Studies on similar caregiver programs have also found them safe, with participants reporting positive experiences without serious problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Caregiver Program for Pediatric Cancer because it offers a virtual, structured support system for caregivers via Zoom, which is not common in standard care. Unlike typical options that may involve sporadic support groups or individual therapy, this program provides a consistent 13-session schedule, potentially enhancing caregiver resilience and emotional well-being. Additionally, the program includes in-depth interviews to capture caregivers' experiences, offering researchers valuable insights that could improve future support interventions.

What evidence suggests that this caregiver program is effective in reducing stress and improving quality of life for Latino caregivers of children with cancer?

Research shows that programs designed to help caregivers of children with cancer can greatly reduce stress and improve their quality of life. Studies have found that these programs increase caregivers' confidence in handling their duties, with some reporting higher self-confidence scores. These support programs provide emotional relief, making it easier for caregivers to manage the challenges of their child's illness. Additionally, the family-focused approach in these programs often reduces emotional distress. This trial will evaluate the effectiveness of a structured support session, specifically the 13-week program, which could help caregivers manage stress and enhance their overall well-being. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. withpower.com withpower.com/trial/phase-caregiver-burden-7-2021-aa20f

Caregiver Program for Pediatric Cancer · Info for Participants ... 13-week session program will have tolerable side effects & efficacy for patients with Caregiver Burden, Cancer, Quality of Life, Pediatric Cancer and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4670577/

Effects of Enhanced Caregiver Training Program on Cancer ... The baseline mean self-efficacy among participating caregivers was high at 70.4 (72.0 for Enhanced-CT vs. 69.0 for EDUC). Caregivers in the Enhanced-CT group ...

3. esmoopen.com esmoopen.com/article/S2059-7029(24)01262-6/fulltext

results of a multicenter non-randomized controlled trial A comprehensive support program for families with parental cancer (Family-SCOUT): results of a multicenter non-randomized controlled trial

4. researchprotocols.org researchprotocols.org/2025/1/e73304

Effect of a Family-Centered Empowerment Model–Based ... This study aims to recruit family caregivers of children with malignant neoplasms to develop a corresponding intervention program based on the ...

5. publications.aap.org publications.aap.org/pediatrics/article/156/4/e2025071134/204188/Acceptance-and-Commitment-Therapy-for-Parents-of

Acceptance and Commitment Therapy for Parents of ... The primary outcomes were parental psychological distress and QoL. Secondary outcomes were parental experience of child's illness, experiential ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11656978/

Assessing caregiver stress and resource needs in pediatric ... This study aimed to analyze the levels of caregiver stress and their resource needs within pediatric cancer care.

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.22.02208

The Childhood Cancer Data Initiative: Using the Power of ... Encouragingly, 5-year pediatric cancer survival rates have increased over the past 50 years, improving from 58% in 1975 to an estimated 85% in ...

8. cancer.gov cancer.gov/about-cancer/coping/family-friends/family-caregivers-hp-pdq

Informal Caregivers in Cancer (PDQ®) - NCI 58% were women. 88% cared for a relative. 39% lived with the person being cared for. 50% reported high emotional stress related to ...