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 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.
Study Type
OBSERVATIONAL
Enrollment
100
Electronic self-report questionnaires before and after integrative interventions, and monthly.
Physical measures before and after integrative interventions, and monthly. Thoracic kyphosis will be measured with a non-invasive gravity dependent inclinometer (Isomed Inc.).
Childrens Hospital Colorado
Aurora, Colorado, United States
University of Colorado Hospital
Aurora, Colorado, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
Determine the type of of therapy administered per cohort
The team will determine which therapy will be used when administering the questionnaire
Time frame: 12 months
Determine the type of therapy administered per participant
The team will determine which therapy will be used when administering the questionnaire
Time frame: 12 months
The mean length of time of intervention per cohort
The team will identify which therapy will be used when administering the questionnaire. The type of therapy will determine the length of time.
Time frame: 12 months
The mean length of time of intervention per patient
The team will identify which therapy will be used when administering the questionnaire. The type of therapy will determine the length of time.
Time frame: 12 months
Accrual rate based on eligible patients
The accrual rate based on percentage of eligible patients who are approached vs how many sign consent.
Time frame: 12 months
Patient satisfaction of integrative intervention
Identify patient satisfaction of integrative intervention by having the patient rate the integrative intervention
Time frame: 12 months
Determine level of symptom interference in active treatment using the PRO-CTCAE
The Pediatric Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system is content valid for children ages 7 years and older The 15 core CTCAE terms are abdominal pain, constipation, diarrhea, mucositis, nausea, vomiting, fatigue, pain, anorexia, headache, peripheral sensory neuropathy, anxiety, depression, insomnia, and cough. The measure uses a 4-point Likert-type scale to assess frequency, severity, and level of interference.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 months
Determine Patient QOL using Pediatric PROMIS
Determine patient Quality of Life (QOL) using Pediatric Patient Reported Outcomes Measurement Information System (PROMIS). Acceptable item and scale reliability have been documented. Items are scored from 0 (never) to 4 (almost always) for symptom interference and psychological measures, and from 0 (with no trouble) to 4 (not able to do) for performance measures. All domains use a 5-point Likert scale and are reported as individual domain scores.
Time frame: 12 months
Determine Emotional Pain Using the Faces Scale
The Faces Scale has been used for evaluating emotional responses to pain on children 3-17 years old. It is a one page form with nine faces in order of happy to upset. Numerical values are given to each face as determined by childrens' perspectives for an affective value by asking 200 children to directly scale the feelings depicted by the faces.
Time frame: 12 months
Determine Patient Satisfaction Using a 5-point Likert Scale
A satisfaction questionnaire will be included as the final question in the post-intervention tool and in the three-month follow up tool. Satisfaction with each type of intervention received will be measured by a five-point Likert scale.
Time frame: 12 months
Determine Number of Patients with Active Heart Rate Monitoring During Intervention
Collect data on the percentage of patients who have active heart rate monitoring during the intervention to give a general of the possibility of gathering vital sign data in the future.
Time frame: 12 months
Determine Patient Posture Using an Inclinometer
Thoracic kyphosis will be measured with a non-invasive gravity dependent inclinometer (Isomed Inc.). The patient will assume a relaxed standing position with feet together. The evaluator palpates the spinous processes of thoracic vertebrae (T) 1, T2, T12, and lumbar vertebrae (L)1 for inclinometer placement. First, the caudal inclinometer is placed on T12 and L1, and then the cranial inclinometer is placed at T1 and T2. The angle on each of the inclinometers is then read and recorded. The thoracic kyphosis angle is calculated by the sum of the two inclinometer readings.
Time frame: 12 months