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Completed

NCT Number: NCT05594693

Integrative Health Interventions in Symptom Management of Pediatric Patients

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.

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Key information

Conditions

Cancer Neoplasms Pediatric Cancer

Age range

30 day–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Childrens Hospital Colorado, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

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

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.).

Other names: Inclinometer

Primary outcomes

  1. Determine the type of of therapy administered per cohort

    Time frame: 12 months

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

  2. Determine the type of therapy administered per participant

    Time frame: 12 months

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

  3. The mean length of time of intervention per cohort

    Time frame: 12 months

    The team will identify which therapy will be used when administering the questionnaire. The type of therapy will determine the length of time.

  4. The mean length of time of intervention per patient

    Time frame: 12 months

    The team will identify which therapy will be used when administering the questionnaire. The type of therapy will determine the length of time.

  5. Accrual rate based on eligible patients

    Time frame: 12 months

    The accrual rate based on percentage of eligible patients who are approached vs how many sign consent.

  6. Patient satisfaction of integrative intervention

    Time frame: 12 months

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

  7. Determine level of symptom interference in active treatment using the PRO-CTCAE

    Time frame: 12 months

    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.

  8. Determine Patient QOL using Pediatric PROMIS

    Time frame: 12 months

    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.

  9. Determine Emotional Pain Using the Faces Scale

    Time frame: 12 months

    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.

  10. Determine Patient Satisfaction Using a 5-point Likert Scale

    Time frame: 12 months

    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.

  11. Determine Number of Patients with Active Heart Rate Monitoring During Intervention

    Time frame: 12 months

    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. Determine Patient Posture Using an Inclinometer

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • OHSU Knight Cancer Institute

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2024
First posted
Oct 26, 2022
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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