Quality of LifeNCT06622252
Intervention Development and Evaluation to Reduce Disparities in Quality of Life for Latino Families Impacted by Cancer
A study testing 13-week session program in people with Quality of Life and Pediatric Cancer, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Pediatric Cancer, Caregiver Burden
- What is being tested?
- 13-week session program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2021to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- 13-week session program
- Medical subject headings
- Neoplasms, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13-week session programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, immediately after the intervention, and 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start20 Aug 2021
- Primary completion1 Sep 2023
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Orange County
- Responsible party
- Principal investigator, Michelle Fortier, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622252
- Sponsor's protocol ID
- 20216922
- Other IDs
- ALS-5577146
- Status last verified
- Feb 2025
- First submitted
- 3 Sep 2024
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Development and Evaluation to Reduce Disparities in Quality of Life for Latino Families Impacted by Cancer
- ClinicalTrials.gov ID
- NCT06622252
- Acronym / sponsor ID
- 20216922
- Conditions
- Quality of Life, Pediatric Cancer, Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Children's Hospital of Orange County
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Session (Corazones) Group | Experimental | Other: 13-week session programCaregivers 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. |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 13-week session programThe 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. | Other | Intervention Session (Corazones) Group |
Primary outcome
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
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 13-week session program in people with Quality of Life and Pediatric Cancer, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Perceived Stress (time frame: baseline, immediately after the intervention, and 3 months post intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.