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OpenTrials
Completed

NCT Number: NCT06622252

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHOC Children's

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Parental Perceived Stress

    Time frame: baseline, immediately after the intervention, and 3 months post intervention

    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

  2. Parental emotional functioning (ANXIETY)

    Time frame: baseline, immediately after the intervention, and 3 months post intervention

    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.

  3. Parental emotional functioning (DEPRESSION)

    Time frame: baseline, immediately after the intervention, and 3 months post intervention

    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.

  4. Parental Quality of Life

    Time frame: baseline, immediately after the intervention, and 3 months post intervention

    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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Children's Hospital of Orange County

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Oct 2, 2024
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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