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

NCT ID: NCT06622252

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-20
• Study Completion Date: 2025-07-31

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.

Detailed Description

Phase 1:

Following informed consent, participants will be asked to complete measures at baseline, post intervention(T2), and 3 months post intervention (T3). Once baseline questionnaires are completed, subjects will participate in a 13-week intervention, comprised of live sessions aimed to address the components of, health literacy, caregiver wellness, and culturally competent care. Content of the sessions include culinary medicine, psycho-education, complementary alternative medicine, gardening, dance-based movement, question-answer forums and spirituality.

Participants will have access to a study specific a site which host recordings of all intervention sessions delivered throughout the intervention period and will track frequency and duration of video usage. Additionally, participants will have the opportunity to connect with each other outside of weekly sessions, using the chat feature within the video hosting platform.

All parts of the 13-session intervention will be delivered virtually via Zoom to ensure accessibility. Sessions will be scheduled on the dates and times most convenient for participants to encourage regular caregiver attendance. Zoom links will be shared with participants on a weekly basis via text or email. All sessions will be delivered in Spanish by native Spanish speakers with the exception of week 7 of the intervention. A translator will be present to facilitate this session.

Sessions are intended for caregivers specifically, however, other members of the family may join if they choose to. Sessions may require supplies for participant participation and engagement. In these circumstances the research team will provide supply kits to each participant. Additionally, participants will be loaned tablets as well as mobile hotspots throughout the intervention period to ensure equal opportunity for participation in this virtual pilot intervention. A member of the research team will be present at each session taking notes and assisting with any technical issue that may arise.

Immediately following the program, caregivers will be asked to participate in focus group or individual interview (qualitative) and to complete a measure of content and usability (quantitative) In addition the investigators will also interview our session experts/presenters to get their overall impressions of their intervention component. These interviews will be audio recorded.

Phase 2:

Procedures for phase 2 will remain the same for participants randomized to the intervention group. However, participants in the control group will only be asked to complete study questionnaires. To allow equal opportunity to control participants, caregivers will have the opportunity to attend intervention sessions after the 3 month follow up surveys are completed. Caregivers will not be compensated for attendance and sessions will not be recorded at this point.

Conditions

Quality of Life; Pediatric Cancer; Caregiver Burden

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Session (Corazones) Group

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 Type: EXPERIMENTAL

13-week session program

Intervention Type: 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.

Control Group (standard of care)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

13-week session program

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 Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital of Orange County

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Michelle Fortier

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHOC Children's

Orange, California, United States

Countries

United States

Other Identifiers

ALS-5577146

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20216922

Identifier Type: -

Identifier Source: org_study_id