Intervention Development and Evaluation to Reduce Disparities in Quality of Life for Latino Families Impacted by Cancer

NCT06622252 | Completed

• 2 other identifiers: 20216922ALS-5577146
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Quality of Life; Pediatric Cancer; Caregiver Burden

Outcome Measures

Primary Outcomes (4)

• Parental Perceived Stress

  Parental stress will be assessed using the Perceived Stress Scale (PSS). The PSS is a widely used 14-item self-report measure of perceived stress. Parents will be asked to rate statements such as "In the past month, how often have you been upset because of something that happened unexpectedly?" and "In the past month how often have you felt that things were going your way?" Subjects rate the items on a 5-point Likert-type scale with higher scores reflecting greater perceived stress. Seven items are reverse-keyed and items are summed to obtain the final score. Scores range from 0 -56 with higher scores indicating higher level of perceived stress. The PSS has been shown to have adequate reliability and validity

  baseline, immediately after the intervention, and 3 months post intervention

• Parental emotional functioning (ANXIETY)

  Parental emotional functioning will be measured using the Patient-Reported Outcome Measures (PROMIS) short form 8a (Anxiety). This form assesses 8 items of emotional stress and produces a standardized score ranging from 8-40 with higher raw scores signifying poorer emotional functioning.

  baseline, immediately after the intervention, and 3 months post intervention

• Parental emotional functioning (DEPRESSION)

  Parental emotional functioning will be measured using the Patient-Reported Outcome Measures (PROMIS) short form 8a (Depression). This form assesses 8 items of emotional stress and produces a standardized score ranging from 8-40 with higher raw scores signifying poorer emotional functioning.

  baseline, immediately after the intervention, and 3 months post intervention

• Parental Quality of Life

  Parental quality of life (Health Survey) will be assessed using the Medical Outcomes Survey (MOS Short Form-36), which is a widely used measure of both physical and mental functioning. scores range from 0-100 with lower scores representing more disability. The higher the score the less disability. Reliability and validity are good.

  baseline, immediately after the intervention, and 3 months post intervention

Study Arms (2)

Intervention Session (Corazones) Group

EXPERIMENTAL

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.

Other: 13-week session program

Control Group (standard of care)

NO 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.

Interventions

13-week session program OTHER

The newly designed intervention was split into three major components - Healthy Literacy, Caregiver Wellness, and Culturally Competent Care and is delivered throughout a 13-session program delivered via Zoom. Sessions are guided by a psychologist, nutritionist, spirituality specialist, social worker, case coordinator, oncologist and traditional Chinese medicine practitioner. Sessions are intended for caregivers specifically, however, other members of the family may join if they choose to.

Intervention Session (Corazones) Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregiver of a Children's Hospital of Orange County (CHOC) oncology patient between the ages of 2-17 years old
• Caregiver of a CHOC oncology patient within 12 months of cancer diagnosis
• Caregiver of CHOC oncology patient must be able to speak and/or read and write in Spanish.
• Caregiver identifies as Latino

You may not qualify if:

• Presence of developmental disabilities, cognitive impairment, or severe psychiatric illness that would preclude participation in intervention sessions or interviews among caregivers and patients
• Caregiver unable to speak, read, and write in Spanish

Sponsors & Collaborators

• University of California, Irvine: lead
• Children's Hospital of Orange County: collaborator

Study Sites (1)

CHOC Children's

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Neoplasms; Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The first phase of this study involved qualitative and quantitative data collection and intervention feasibility testing using a single-arm within-subjects design. Our Community Based Participatory Research (CBPR) work to date has identified several barriers and targets for intervention. Accordingly, the newly designed intervention was split into three major components - Healthy Literacy, Caregiver Wellness, and Complementary Alternative Medicine. The second phase of this study is a preliminary randomized control trial.

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: October 2, 2024
• Study Start: August 20, 2021
• Primary Completion: September 1, 2023
• Study Completion: July 31, 2025
• Last Updated: October 16, 2025

Record last verified: 2025-02

Locations

US (1)