Integrative Health Interventions in Symptom Management of Pediatric Patients

Cancer Clinical Trial

Official title:

QuICK: A Quality of Life Study of Integrative and Complementary Therapies for Kids (An Exploratory Feasibility Study of Data Collection)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05594693
• Other study ID #: 21-3665.cc
• Secondary ID: NCI-2022-05216
• Status: Recruiting
• Start date: June 16, 2022
• Est. completion date: November 2026

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: Jennifer Raybin, PhD
• Phone: 5034187802
• Email: Raybin[@]ohsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2026
• Est. primary completion date: February 2025
• Gender: All
• Age group: 30 Days to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Pediatric Cancer

Intervention

Other:
• Questionnaire
Electronic self-report questionnaires before and after integrative interventions, and monthly.
• Physical Exam
Physical measures before and after integrative interventions, and monthly. Thoracic kyphosis will be measured with a non-invasive gravity dependent inclinometer (Isomed Inc.).

Locations

Country	Name	City	State
United States	Childrens Hospital Colorado	Aurora	Colorado
United States	University of Colorado Hospital	Aurora	Colorado
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	OHSU Knight Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the type of of therapy administered per cohort	The team will determine which therapy will be used when administering the questionnaire	12 months
Primary	Determine the type of therapy administered per participant	The team will determine which therapy will be used when administering the questionnaire	12 months
Primary	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.	12 months
Primary	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.	12 months
Primary	Accrual rate based on eligible patients	The accrual rate based on percentage of eligible patients who are approached vs how many sign consent.	12 months
Primary	Patient satisfaction of integrative intervention	Identify patient satisfaction of integrative intervention by having the patient rate the integrative intervention	12 months
Primary	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.	12 months
Primary	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.	12 months
Primary	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.	12 months
Primary	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.	12 months
Primary	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.	12 months
Primary	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.	12 months