Clinical trial NCT05594693: Integrative Health Interventions in Symptom Management of Pediatric Patients
Official title: QuICK: A Quality of Life Study of Integrative and Complementary Therapies for Kids (An Exploratory Feasibility Study of Data Collection)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Pediatric Cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: OHSU Knight Cancer Institute
First posted: 2022-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 30
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at CHCO include premature infants through young adults. Any of these patients could benefit from integrative treatments. The treatments will only be offered after medical team approval and parental consent. All treatments will be provided by credentialed and licensed providers and will follow CHCO approved policies and procedures.

Brief summary: As healthcare demands high-quality cost-effective care and patients seek self-management strategies, integrative medicine has become more of an interest to patients, physicians, and administrators. The NIH has a dedicated center (National Center for Complementary and Integrative Health) for integrative therapies. Additionally, these treatments must meet evidence-based criteria for efficacy to be considered for reimbursement and in order for clinical settings to integrate them into the standard of care.

Detailed description: The care of children at the quaternary children's hospital is focused in traditional Western medicine modalities of diagnosis, surgery, and medical treatment with pharmacologic medications. However, integrative health modalities, such as acupuncture, massage, Reiki, nutritional supplements, or oral complementary therapies (such as cannabinoids) have been increasingly discussed by our patients, especially during Palliative Care Consults. As healthcare demands high-quality cost-effective care and patients seek self-management strategies, integrative medicine has become more of an interest to patients, physicians, and administrators. The NIH has a dedicated center (National Center for Complementary and Integrative Health) for integrative therapies. Additionally, these treatments must meet evidence-based criteria for efficacy to be considered for reimbursement and in order for clinical settings to integrate them into the standard of care. The objective of this project is to examine feasibility, timing, appropriate measures, and provide the basis for future in-depth study of the outcomes of individual integrative symptom management strategies.

Hypotheses:

Children, adolescents, and young adults will be able to complete electronic self-report questionnaires and physical measures before and after integrative interventions, and monthly.

Caregivers will be able to complete electronic proxy questionnaires before and after integrative interventions, and monthly.

Integrative interventions will be associated with changes on the questionnaires and physical measures such as a decrease in frequency, severity, or level of interference with symptoms.

Participants will rate their satisfaction with integrative interventions positively.

Eligibility criteria: Inclusion Criteria:

* Any CHCO patient referred for integrative interventions by the Pain Service or the Palliative Care Service

Exclusion Criteria:

* Patients who have non-consenting providers or caregivers
* Any patient the medical team feels is inappropriate for the study

Primary outcomes:
measure: Determine the type of of therapy administered per cohort
timeFrame: 12 months
measure: Determine the type of therapy administered per participant
timeFrame: 12 months
measure: The mean length of time of intervention per cohort
timeFrame: 12 months
measure: The mean length of time of intervention per patient
timeFrame: 12 months
measure: Accrual rate based on eligible patients
timeFrame: 12 months
measure: Patient satisfaction of integrative intervention
timeFrame: 12 months
measure: Determine level of symptom interference in active treatment using the PRO-CTCAE
timeFrame: 12 months
measure: Determine Patient QOL using Pediatric PROMIS
timeFrame: 12 months
measure: Determine Emotional Pain Using the Faces Scale
timeFrame: 12 months
measure: Determine Patient Satisfaction Using a 5-point Likert Scale
timeFrame: 12 months
measure: Determine Number of Patients with Active Heart Rate Monitoring During Intervention
timeFrame: 12 months
measure: Determine Patient Posture Using an Inclinometer
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Childrens Hospital Colorado
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Jennifer Raybin
role: PRINCIPAL_INVESTIGATOR
References: