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Trial Title:
Integrative Health Interventions in Symptom Management of Pediatric Patients
NCT ID:
NCT05594693
Condition:
Cancer
Pediatric Cancer
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Questionnaire
Description:
Electronic self-report questionnaires before and after integrative interventions, and
monthly.
Arm group label:
Patients Referred by the Pain Service or Palliative Care Service
Intervention type:
Other
Intervention name:
Physical Exam
Description:
Physical measures before and after integrative interventions, and monthly. Thoracic
kyphosis will be measured with a non-invasive gravity dependent inclinometer (Isomed
Inc.).
Arm group label:
Patients Referred by the Pain Service or Palliative Care Service
Other name:
Inclinometer
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
30 Days
Maximum age:
30 Years
Locations:
Facility:
Name:
Childrens Hospital Colorado
Address:
City:
Aurora
Zip:
80045
Country:
United States
Facility:
Name:
University of Colorado Hospital
Address:
City:
Aurora
Zip:
80045
Country:
United States
Facility:
Name:
OHSU Knight Cancer Institute
Address:
City:
Portland
Zip:
97239
Country:
United States
Start date:
June 16, 2022
Completion date:
November 2026
Lead sponsor:
Agency:
University of Colorado, Denver
Agency class:
Other
Collaborator:
Agency:
OHSU Knight Cancer Institute
Agency class:
Other
Source:
University of Colorado, Denver
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05594693
