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

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

NCT ID: NCT06622252

Condition: Quality of Life
Pediatric Cancer
Caregiver Burden

Conditions: Official terms:
Caregiver Burden

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: 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.

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: 13-week session program
Description: 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.
Arm group label: Intervention Session (Corazones) Group

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: University of California, Irvine

Address:
City: Orange
Zip: 92868
Country: United States

Start date: August 20, 2021

Completion date: July 31, 2025

Lead sponsor:
Agency: University of California, Irvine
Agency class: Other

Collaborator:
Agency: Children's Hospital of Orange County
Agency class: Other

Source: University of California, Irvine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06622252