Clinical trial NCT06622252: Intervention Development and Evaluation to Reduce Disparities in Quality of Life for Latino Families Impacted by Cancer
Official title: Intervention Development and Evaluation to Reduce Disparities in Quality of Life for Latino Families Impacted by Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Quality of Life
Pediatric Cancer
Caregiver Burden
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Orange County
First posted: 2024-10-02
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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

Primary outcomes:
measure: Parental Perceived Stress
timeFrame: baseline, immediately after the intervention, and 3 months post intervention
measure: Parental emotional functioning (ANXIETY)
timeFrame: baseline, immediately after the intervention, and 3 months post intervention
measure: Parental emotional functioning (DEPRESSION)
timeFrame: baseline, immediately after the intervention, and 3 months post intervention
measure: Parental Quality of Life
timeFrame: baseline, immediately after the intervention, and 3 months post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: CHOC Children's
state: California
Study officials:
References: