Integrative Health Interventions in Symptom Management of Pediatric Patients

NCT05594693 | Completed DMC

• 2 other identifiers: 21-3665.ccNCI-2022-05216
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Pediatric Cancer; Cancer

Outcome Measures

Primary Outcomes (12)

• Determine the type of of therapy administered per cohort

  The team will determine which therapy will be used when administering the questionnaire

  12 months

• Determine the type of therapy administered per participant

  The team will determine which therapy will be used when administering the questionnaire

  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.

  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.

  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.

  12 months

• Patient satisfaction of integrative intervention

  Identify patient satisfaction of integrative intervention by having the patient rate the integrative intervention

  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.

  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.

  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.

  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.

  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.

  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.

  12 months

Study Arms (1)

Patients Referred by the Pain Service or Palliative Care Service

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

Other: Questionnaire; Other: Physical Exam

Interventions

Physical Exam OTHER

Physical measures before and after integrative interventions, and monthly. Thoracic kyphosis will be measured with a non-invasive gravity dependent inclinometer (Isomed Inc.).

Also known as: Inclinometer

Patients Referred by the Pain Service or Palliative Care Service

Questionnaire OTHER

Electronic self-report questionnaires before and after integrative interventions, and monthly.

Patients Referred by the Pain Service or Palliative Care Service

Eligibility Criteria

• Age: 30 Days - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• OHSU Knight Cancer Institute: collaborator

Study Sites (3)

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires; Restraint, Physical

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Study Officials

• Jennifer Raybin

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: October 26, 2022
• Study Start: June 16, 2022
• Primary Completion: October 25, 2022
• Study Completion: February 26, 2024
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)